Focus on Medical Devices

Life Sciences Group Seminar Thursday, November 17, 2011

Timothy M. Squire Partner 416 868 3462 [email protected]

GUEST SPEAKER: Daniel Yoon Regulatory Information Officer Medical Devices Bureau, Health Canada

I N S T I T U T E

Your Health and Safety... Our priority

Votre santé et votre Securité… notre priorité

Overview of the Medical Device Licensing Process Daniel Yoon Medical Devices Bureau Health Canada November 17, 2011

Health Products & Food Branch Health Products & Food Branch Therapeutic Products Directorate

Biologics & Genetic Therapies Directorate

Natural Health Products Directorate

Health Products & Food Litigation Secretariat

Office of Consumer Affairs & Public Involvement

Food Directorate

Office of Regulatory & International Affairs

Policy & Strategic Planning Directorate

Office of Nutrition Policy & Promotion

Inspectorate

Marketed Health Products Directorate

Regional Offices Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

Therapeutic Products Directorate A/Director General B. Sabourin Office of Patented Medicines & Liaison

Office of Business Transformation

Senior Medical Advisor Bureau Bureau of Metabolism, Oncology, & Reproductive Sciences

Bureau of Gastroenterology, Infection & Viral Diseases

Medical Devices Bureau D. Boyer

Bureau of Cardiology, Allergy & Neurological Sciences

Bureau of Pharmaceutical Sciences

Policy Bureau

Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

Medical Devices Bureau A/Director Don Boyer Administration Shannon Laferriere

Associate Director Carey Agnew

•Administration •Personnel & Human Resources •Finance

Device Evaluation Division P Neufeld (Acting) •Safety & Effectiveness Reviews •Cardiovascular •In Vitro Diagnostic •Musculoskeletal •General & Restorative •Investigational Testing •Special Access Programme

Device Licensing Services Division N Shadeed •Licensing Services •Regulatory & Scientific •Information Dissemination •License Processing •Quality Systems

Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

Definition of a Device

“DEVICE” means any article, instrument, apparatus of contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in: a) The diagnosis, treatment, mitigation, or prevention of a disease, disorder, or abnormal physical state, or its symptoms, in human beings or animals, b) Restoring, correcting or modifying a body function or the body structure of human beings or animals.

Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

Definition of a Device

c) The diagnosis of pregnancy in human beings or animals, or d) The care of human beings or animals during pregnancy and at and after birth of the offspring, including care of the offspring, and includes a contraceptive device but does not include a drug. “MEDICAL DEVICE” means a device within the meaning of the Act, but does not include any device that is intended for use in relation to animals

Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

Manufacturer

• A manufacturer in the Regulations: – Sells a medical device under their own name, trade-mark, design, trade name or other name owned or controlled by the person – Is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the device, assigning it a purpose – Performs or has someone perform on their behalf Manufacturer = Name on the label

Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

Food and Drugs Act

General Prohibitions: • Advertising, labelling or sale of devices to the general public for specific medical conditions (section 3) • Sale of devices that are unsafe when used according to directions (section 19) • Sale, advertising, labelling, packaging, treatment and processing of devices in a false, misleading or deceptive manner (section 20) • Devices must meet with standards where prescribed (section 21)

Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

Regulatory Provisions: Essentials

• Health Canada regulates the advertising, manufacture and sale of medical devices in Canada • The Food and Drugs Act and Medical Devices Regulations are the tools used to ensure that safe and effective devices are available • Manufacturers of devices apply to Health Canada to receive either a Licence or an Authorization to sell their devices

Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

Manufacturer / Importer / Distributor

...no person shall import or sell a Class II, III or IV medical device unless the manufacturer of the device holds a licence in respect of that device or, if the medical device has been subjected to a change described in section 34, an amended medical device licence Importers / Distributors / Manufacturers of Class I devices not employing a licensed importer / distributor require an Establishment Licence

Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

Regulatory Framework

Canada has captured successful elements from other regulatory systems – – – –

Risk based classification system – EU Post-Market – USFDA Quality System Requirement – EU Pre-Market Licensing – USFDA

Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

Classification of a Medical Device

• The Medical Devices Regulations set out a system for classifying medical devices into one of four classes; Class I representing the lowest risk and Class IV representing the highest risk. • The degree of regulatory oversight assigned to a medical device is dependent upon it classification

Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

Schedule 1 – The Classification Rules

• To determine the classification of a device, you must apply all of the rules in Schedule 1 – Part 1 applies to devices in general – Part 2 applies to in vitro diagnostic devices

• You must consider the labelled indications for use, or claims made for the device

Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

Classification System Logic

• Non-IVDDs – Large number of variables – Rapid technological advances – Classification criteria based on • The human body • Inherent device related potential hazards • Customary device use (O.R., I.C.U., N.I.C.U.)

Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

In vitro Diagnostic Devices (IVDD)

• “In vitro diagnostic device" or "IVDD" means a medical device that is intended to be used in vitro for the examination of specimens taken from the body. • The higher the risk associated with a false positive / false negative, the higher the Class

Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

Regulatory Framework • • • • • •

Class I (low risk)  Class IV (high risk) Pre-market resources apply primarily to Class III & IV Product Licensing applies to Class II, III & IV QS requirements apply to Class II, III and IV Post-market requirements apply to all Classes Establishment Licensing applies primarily to importers / distributors / Class I manufacturers

Class IV – 5% Class III – 15% Class II – 40% Class I – 40% (NB: approx. 1M individual devices currently licensed) Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

Regulatory Framework

• Licensing – need to know the industry / products we regulate – however – needs to be done in a timely / efficient manner (Class II – 15 days, Class III – 75 days, Class IV – 90 days) • Class II devices – attestation device meets requirements – responsibility rests with manufacturer • QS (ISO 13485) – partnered with Standards Council of Canada – established third party auditing program – paid for by industry – program is still evolving but remains a model for regulators • Annual Licence Renewal – accurate information as to what products are on the Canadian market (legally)

Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

Examples of Classified Devices

• Class I :

Reusable surgical instruments, bandages, cell culture media

• Class II:

Blood pressure monitors, electrodes, corrective contact lenses, pregnancy test kits, single use surgical instruments, catheters

• Class III:

Ventilators, cardiac monitors, hip implants, knee implants, lasers, Chlamydia test kits, glucose meters

• Class IV:

Defibrillators, pacemakers, coronary stents, HIV test kits, neurosurgical shunts Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

Quality Management System Certification

Depending on the risk, the QMS under which a device is • Manufactured shall satisfy ISO 13485:2003 (Class II devices) – Design and development can be excluded • Designed and manufactured shall satisfy ISO 13485:2003 (Class III & IV devices)

Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

Quality Management System Certification Major features of ISO 13485 • •

• •

Specifies the requirements for the QMS that can be used by an organization for the design and development, production, installation and servicing of medical devices Covers areas such as – Design and development, manufacturing and testing – Labelling, storage, transport, packaging and servicing – Reporting, preventive and corrective actions – Management responsibilities, human resources, infrastructure and work environment – Documentation and records – Internal audits and improvement Does not specify how to do an activity, but require procedures as to how the activities are done and controlled Requires the inclusion of all applicable regulatory requirements in the QMS Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

Quality Management System Certification

• Manufacturer obligated to select a registrar recognized by HC in order to comply with the Canadian QMS requirements – Registrar provides third party auditing and certification services to manufacturer under specific conditions defined by HC – HC not involved in fee or service arrangements between parties

• Registrar not allowed – To provide advice, consulting services or interpretations on the MDR – To act as the manufacturer’s representative with regards to regulatory issues

Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

Quality Management System Certification

Participants • • • •

ITS Dekra Lloyds LGA

• LNE/G-Med • TÜV USA • TÜV Rheinland • TÜV SÜD

• UL • NSAI • DQS • BSI

• SGS • SAI • TGA

Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

Device Licence Class II Identification Information

Attestation of Compliance with:

ISO 13485:2003

-Safety and Effectiveness (S&E)

Quality System

-Intended Use/Purpose to verify class -Application Type Certificate from CMDCAS recognized auditing organization

Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

Device Licence Class III Identification Information

Same as Class II plus:

ISO 13485:2003

-Label

Quality System

-List of recognized standards used in mfg -Description of material in mfg and packaging -Method of sterilization -Summaries and conclusions of S&E studies

Certificate from CMDCAS recognized auditing organization

-Marketing History (# sold, where, problem reports and recalls) Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

Device Licence Class IV Identification Information

Same as Class II plus:

ISO 13485:2003

-Label, risk assessment, risk reduction measures & quality plan

Quality System

-Material specifications Certificate from CMDCAS recognized auditing organization

-Manufacturing Process -Detailed Information – S&E: -Pre-clinical and clinical studies -Process validation studies -Software validation studies -Literature studies

Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

Other Regulatory Provisions

• • • •

Mandatory Problem Report Recalls Complaint Handling / Distribution Records Special Access - devices for emergency use or if conventional therapies have failed, are unavailable or are unsuitable • Investigation Testing – clinical trials involving human subjects

Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

Licences Renewed Annually 35000 30000

26178 26802

25000 20000

20769

28331

30217

22955

18114 15556

15000 10000 5000 0 2003 2004 2005 2006 2007 2008 2009 2010 Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

Licences Held by Country (Jan. 2011) Denmark 567 2%

Sweden 304 1%

All others 2705 9%

Switzerland 601 2% Japan 752 2%

United States 18332 59%

France 891 3% Great Britain 1198 4% Canada 2360 8%

United States Germany Canada Great Britain France Japan Switzerland Denmark Sweden All others

Germany 3020 10%

Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

New Initiatives

• Patient management software • Electronic applications • Cost recovery • STED

Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

Patient Management Software

• Considered a medical device if it – (1) provides the only means and opportunity to capture or acquire data from a medical device for aiding directly in diagnosis or treatment of a patient; or – (2) replaces a diagnostic or treatment decision made by a physician • Regulated as either Class I (Rule 12) or Class II (Rule 10)

Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

Electronic Applications

• Pilot project began in 2010 with new Class IV applications • Expanded to include Class IV amendments, new and amendment Class III applications • Manufacturers now requested to submit in both paper and electronic format • Begins the transition to paperless applications

Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

Cost Recovery Initiative

• Licensing fees have not increased since their introduction in 1998 • New fees came into force April 1, 2011 – Class II: $200$350 – Class III: $1980 ($2420 for near patient IVDD)$5050 ($8600 for near patient IVDD) – Class IV: variable$11 750 ($10 960 for devices containing biological material, $20 030 for near patient IVDD)

Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

Cost Recovery Initiative

• Amendment fees – Significant change related to manufacturing: $1270 (Class III and IV) – Any other significant change or change that would affect the device class: $4730 (Class III), $5390 (Class IV) • No fees for faxbacks, private label applications and Class II amendments • Fees to increase annually by 2% Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

Cost Recovery Initiative

• MDB must meet performance standards for 90% of applications to avoid penalties – Class II: 15 days – Class III: 60 days from Screening Acceptance Letter – Class IV: 75 days from Screening Acceptance Letter

Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

STED

• Summary Technical Documentation, similar to the eCTD • Developed by Study Group 1 of the Global Harmonization Task Force (GHTF) • Intended to harmonize requirements across jurisdictions • Health Canada now accepting applications in STED format

Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

New Address

• MDB moving November 25, 2011 • Applications should be sent to 2934 Baseline Rd., Tower B A.L. 3403A Ottawa, ON K1A 0K9

Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

Questions?

Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

Medical Device Promotion In Canada

Restrictions On Pre-market Promotion And Responding To RFPs What Device Manufactures Can And Cannot Do Timothy Squire, Fasken Martineau November 17, 2011

Does This Sound Familiar? • A company executive talks about a medical device in your pipeline during a media interview • You just found out that a device you have been selling requires a medical device license (e.g. software, Class II not Class I) • A medical consultant or clinical investigator publishes a paper on your medical device under development • Your sales team has started promoting an improved version 2.0 of your licensed device without a medical device license amendment • An account hears about the approval of a new medical device in the US and asks about it • A device marketed by your company in the US is promoted at an international conference/trade show held in Canada • Your sales team has included an “almost licensed” medical device in response to an RFP

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Prohibition on Pre-Market Promotion • Section 27 Medical Devices Regulations: “No person shall advertise a Class II, III or IV medical device for the purpose of sale unless (a) the manufacturer holds a license in respect of that device or, if the device has been subjected to a change described in section 34, an amended medical device license […]”

• Section 34 of the Medical Devices Regulations requires a medical device license amendment where there is a significant change (Class III and IV), change in Class, change in manufacturer, change in identifier, change in indication (Class II)

What Constitutes “Advertisement”? • Section 2 Food and Drugs Act: “advertisement“ includes any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic or device.”

• “any means whatever” can include both verbal and written representations - in any media or setting • “directly or indirectly” can include situations where sale or future sale of the device is hinted or implied • Key Question: Where is the line between legitimate information exchange about an unlicensed device and indirect promotion for sale? • Answer: Depends on the context and overall purpose of the communication

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Information vs. Promotion • No Health Canada Guidance Document on the subject of Medical Device promotion • Look to Health Canada’s drug product policy The Distinction Between Advertising and Other Activities as an informal guide • Information vs. Promotion: • The context in which the message is disseminated • The primary and secondary audience • Who delivers the message • The contents of the message • The frequency of the message

Thanks…But What Should I Really Do? 1. 2.

Keep sales and marketing teams up to date on device development Require that communications regarding pre-market devices are REACTIVE not PROACTIVE: • Prohibit sales representatives from initiating any discussion with potential customers or others about pre-market devices • Script standard responses to potential questions about pre-market devices • Implement an Unsolicited Information procedure 3. Otherwise, carefully pre-plan all events where pre-market device information will or might be disclosed: • Press releases • International conferences held in Canada • Responses to RFPs • Bind consultants under a duty of non-disclosure 4. Build all of this in to a written Corporate Compliance Policy 5. Train company personnel regularly

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Medical Device Catalogue Exception •

Section 27 Medical Devices Regulations: “No person shall advertise a Class II, III or IV medical device for the purpose of sale unless (a) the manufacturer holds a license in respect of that device or, if the device has been subjected to a change described in section 34, an amended medical device license […]”

Medical Device Catalogue Exception •

Section 27 Medical Devices Regulations: “No person shall advertise a Class II, III or IV medical device for the purpose of sale unless (a) the manufacturer holds a license in respect of that device or, if the device has been subjected to a change described in section 34, an amended medical device license; or (b) the advertisement is placed only in a catalogue that includes a clear and visible warning that the devices advertised in the catalogue may not have been licensed in accordance with Canadian law.”

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Medical Device Catalogue Exception •

Section 27 Medical Devices Regulations: “No person shall advertise a Class II, III or IV medical device for the purpose of sale unless (a) the manufacturer holds a license in respect of that device or, if the device has been subjected to a change described in section 34, an amended medical device license; or (b) the advertisement is placed only in a catalogue that includes a clear and visible warning that the devices advertised in the catalogue may not have been licensed in accordance with Canadian law.”

•

Use this catalogue exception if you can – but use with caution

•

The catalogue exception does not open the door to other types of unlawful pre-market promotion

Responding to RFPs • Health Canada letter to hospitals, December 14, 2009: “Advertising Class II, III or IV medical devices prior to obtaining a medical device license is prohibited. A manufacturer’s response to a Request for Proposal (RFP) is also considered to be an “offer for sale”; therefore, if a manufacturer responds to a RFP with a submission of an unlicensed medical device, it would be in contravention of the Regulations. Before entering into any contractual agreement with a manufacturer, we strongly recommend that health care facilities verify that the medical device is licensed by Health Canada.”

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Responding to RFPs • Bottom Line: Against the law to offer to fulfill an RFP with an unlicensed or “almost licensed” medical device • Violation of the Medical Devices Regulations • Could potentially void any contract with the purchaser on the grounds of public policy • Manufacturers and purchasers have been warned – but it is still happening • Can I include any information about unlicensed devices in my bid package?

Not In Compliance – What Now? • Steps to remedy unlawful pre-market promotion depend on whether Health Canada is aware of the violation • If Health Canada is aware of the violation (e.g. Inspectorate brought the violation to your attention) then cooperate: • Timely and cooperative response can help reach a manageable solution • Aggressive approach can lead to enforcement action • If Health Canada is not aware of the violation (e.g. violation discovered internally) then: • Immediately cease the unlawful activity and maintain records to memorialize actions taken • Determine whether self-reporting is appropriate

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Health Canada Enforcement • Criminal penalty for violations of the Medical Devices Regulations: • Fine (up to $5,000) or imprisonment (up to 6 months) or both (s.31 Food and Drugs Act) • Interim enforcement powers of Health Canada Inspectorate: • Inspection • Stop sale notice • Suspension of Medical Device License (s. 40 Regs) • Suspension of Establishment License (s.49 Regs)

Health Canada Enforcement • In general, Health Canada is not out to punish manufacturers for violations of the Medical Devices Regulations unless they are chronic offenders or the violation has led to a serious risk to health and safety • Guidance on Medical Device Compliance and Enforcement (GUI-0073) Policy Statement: “Where noncompliance with the requirements of the Regulations or the Act is identified, the Inspectorate ensures that appropriate actions are taken by the company to address the noncompliance, based on the risk to health. If appropriate actions are not taken to comply with the requirements, the company is subject to enforcement action.”

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Timothy Squire Partner 416 868 3462 [email protected]

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REFERENCE MATERIALS

VANCOUVER

CALGARY

TORONTO

OTTAWA

MONTRÉAL

QUÉBEC CITY

LONDON

PARIS

JOHANNESBURG

POLICY Health Products and Food Branch

Issued: January 12, 1996 Administrative Update: August 2005

The Distinction Between Advertising and Other Activities Issue Health Canada recognizes the importance to the pharmaceutical industry and to the general public of being able to disseminate and access non-promotional information regarding drugs for human use. The purpose of this policy is to clarify the distinction between advertising to promote the sale of a drug and activities that are not primarily intended to promote the sale of a drug (e.g., education, scientific exchange, labelling, shareholder's report, etc.). This policy is NOT intended for use in determining whether or not the drug advertising provisions of the Food and Drugs Act and Regulations are observed.

Scope This policy applies to all types of information disseminated in relation to drugs for use in humans.

Background There are numerous provisions within the Food and Drugs Act and Regulations that apply to drug advertising. In order to determine the applicability of those provisions it is first necessary to determine whether or not a particular message can be considered to be advertising. For the purposes of the Act, advertising is defined as including "any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic or device". If a message regarding a drug is not considered to promote sale or disposal, it is not subject to the advertising provisions of the Food and Drugs Act and Regulations. There is a particular need to distinguish between advertising and non-promotional information in the following situations:

-2-

i)

Prior to market authorization: !

ii)

promotion of a drug prior to market authorization is not permitted (Section 9(1) of the Act, Section C.08.002 of the Regulations) because the terms of such authorization have not been established and the proposed indication(s) for use have not been verified.

After market authorization when information on a drug is disseminated to the general public: !

promotion of a prescription drug (Schedule F) to the general public is limited to name, price and quantity (Section C.01.044 of the Regulations).

!

a drug (prescription or nonprescription) may not be advertised to the general public for the treatment, preventative or cure for any Schedule A disease (Section 3 of the Act).

Considerations In determining whether a message falls within the definition of advertising, the purpose of the message is very significant. It must be determined whether the primary purpose of the message is to promote the sale of a drug or to provide information. Where the primary purpose is not clear, the following factors should be considered in determining whether the message is primarily intended to promote the sale of a drug: !

What is the context in which the message is disseminated? e.g., when and how is the message delivered; what is the milieu or medium of dissemination? Is it a science-based message delivered to scientists/healthcare professionals by an expert, e.g., researcher at a conference with a varied agenda, or is it a product-related message delivered to a group of practicing physicians by the pharmaceutical manufacturers sales representative at a meeting with a limited agenda?

!

Who are the primary and secondary audiences? e.g., are the target audiences limited or unlimited in scope; are the primary and the secondary audiences the same? Where they are different, the message to the secondary audience is more likely to be advertising.

-3-

!

Who delivers the message (the provider)? e.g., the drug manufacturer/its agent or an independent third party (e.g., patient support group). Where delivered by an independent party, the message is less likely to be considered as advertising.

!

Who sponsors the message and how? e.g., the drug manufacturer/its agent or an independent third party; is the sponsorship funding targeted to a specific message, or is it added to the general operating budget for an organization, conference etc.? If the message is sponsored by an independent third party and the funding is added to the general operations budget, the message is less likely to be advertising. Where any fee is paid by the manufacturer to have the message disseminated, it is more likely to be advertising.

!

What influence does a drug manufacturer have on the message content? e.g., what are the linkages between the information, the provider and the manufacturer, the provider and the writer, etc.? Where the drug manufacturer exerts influence (e.g., preparing, editing) on the message content, it is more likely to be advertising.

!

What is the content of the message? eg., are the facts described objectively in a balanced manner, or is emphasis placed on a particular drug or its merits; is the message balanced with respect to description of risks as well as benefits of a treatment option? Can the message withstand a test for scientific rigour? Is the information set in an appropriate context, e.g., a discussion of disease management, scientific research?

!

With what frequency is the message delivered? e.g., is it delivered once or repeatedly? Where the same message is delivered repeatedly, the message is more likely to be considered as advertising.

No one factor in itself will determine whether or not a particular message is advertising. Each message must be evaluated on its own merit and other factors may apply.

.

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Examples of messages delivered in different contexts are discussed in Appendix I. The list of examples is intended as a guide only and is not all inclusive. The same factors for consideration will be applied to other types of messages not listed here. This clarification should assist in distinguishing between advertising and nonpromotional information. It is only after having determined that the primary purpose of a message is advertising that an assessment can be made regarding compliance with the regulations pertaining to drug advertising.

APPENDIX I Examples of Message Types in the Context of Advertising and Non-promotional Information

TABLE OF CONTENTS

Page Press Releases/Press Conferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i Patient Support Group Literature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii Patient Information Booklets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii Consumer Brochures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii Videos and Interactive Electronic Databases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv Continuing Medical Education (CME)/Scientific Symposia/Exhibits . . . . . . . . . . . . . . . . . . . . iv International Conferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v Help-seeking Announcements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v 1-800 Telephone Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vi Unsolicited Request for Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vi Journal Supplements/Inserts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vi Clinical Trial Recruitment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii Formulary Kits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viii Institutional Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viii Reference texts, Peer-reviewed Journal Articles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viii

Examples of Message Types in the Context of Advertising and Nonpromotional Information

Press Releases/Press Conferences: It is common practice for a pharmaceutical manufacturer to release information on new developments in research and at the time of launch of a new drug or a new indication for use of a previously authorized product. A press release or information disseminated at a press conference concerning a drug may be a nonpromotional activity in the following circumstances: !

the announcement is directed to shareholders or potential shareholders,

!

the announcement is limited to the name of the drug and its authorized or proposed therapeutic use,

!

no statement is made regarding the degree of safety or efficacy expected,

!

no comparison is drawn with other treatments,

!

in the case of unauthorized drugs, or unauthorized indications, the message cautions that the safety and efficacy are still under investigation and that market authorization has not yet been obtained, and

!

there is no attempt to influence the pick-up, placement or emphasis given in subsequent publication or broadcast, e.g., no payment is made by the manufacturer to influence the visibility (e.g., section) in the press.

In contrast, a press release or information disseminated at a press conference may be advertising where any of the aforementioned conditions are not met, or where other factors indicate that the primary purpose of the message is to promote the sale of a drug, for example: !

undue emphasis is placed on the drug being a "breakthrough",

!

the press release is subsequently sent or provided to another audience, e.g., mailed to physicians,

!

a fee is paid by the sponsor to have the message published, or broadcast, or

!

in the case of an unauthorized drug, it is indicated that the drug is available through the Special Access Programme,

i

Patient Support Group Literature Patient support groups often publish information in the form of brochures/leaflets that are intended to promote a better understanding of a disease and its treatment among members and potential members. It can be difficult to distinguish between advertising and nonpromotional information in this context. Declaration of sponsorship of the brochure by a drug manufacturer does not in itself render the brochure promotional. Patient support group publications that include information on drugs may be a nonpromotional activity in the following circumstances: !

the content is disease related rather than product related,

!

the various treatment options (drug and nondrug) and their respective risks and benefits are discussed in an objective manner,

!

no emphasis is placed on one drug product, e.g., excessive use of a brand name or description as a " breakthrough", and no emphasis is accorded to the merits of one drug product,

!

no reference is made to an unauthorized drug beyond the mention that research is underway in a particular area, in which case, the regulatory status should be indicated (i.e., market authorization not yet obtained), and

!

no reference is made to the availability of unauthorized drugs through the Special Access Programme.

Patient support group publications may be advertising where any of the aforementioned conditions are not met, and where other factors indicate that the primary purpose of the publication is to promote the sale of a drug.

Patient Information Booklets Information in the form of a leaflet, brochure, or booklet published by the manufacturer about a drug product is not advertising if it pertains only to the drug which it accompanies, and is given to a patient for whom the drug is being, or already has been, prescribed. In these circumstances, the information is considered to be part of the labelling and is, therefore, subject to the relevant regulatory and policy requirements relating to labelling rather than advertising. By contrast, such information packages about a specific product that are distributed independently of the product to consumers for whom the drug has not been prescribed, fall within the definition of advertising.

ii

Consumer Brochures: i)

Consumer brochures include leaflets/brochures that may make reference to but do not accompany a drug product, and are made available directly or indirectly to the consumer by a drug manufacturer, or other organization, by various means, e.g., by mail, in retail outlets, in health professionals waiting rooms, etc. Declaration of sponsorship of such a brochure by a drug manufacturer does not in itself render the information promotional. Consumer brochures may be nonpromotional information in the following circumstances: !

the content is disease related rather than product related,

!

the various treatment options (drug and non-drug) and their respective risks and benefits are discussed in an objective manner,

!

no emphasis is placed on one drug product, e.g., excessive use of a brand name or description of a product as a "breakthrough", and no emphasis is accorded to the merits of one drug product,

!

no reference is made to an unauthorized drug beyond the mention that research is underway in a particular area, in which case, the regulatory status should be indicated (i.e., market authorization not yet obtained), and

!

no reference is made to the availability of unauthorized drugs through the Special Access Programme.

Consumer brochures may be advertising where any of the aforementioned conditions are not met, or where other factors indicate that the primary purpose of the publication is to promote the sale of a drug. ii)

Consumer brochures also include leaflets/brochures that are not product-specific but expound on the pharmacological properties/actions of an ingredient, e.g., herb, vitamin, mineral, etc., and are made available in retail outlets selling products containing the same ingredients. Such information packages may be considered to be advertising for a drug product when displayed in close proximity to or distributed with products containing the same ingredient, in the same retail outlet.

iii

Videos and Interactive Electronic Databases Videos are defined as messages recorded on videotape that make reference to drug products and that may be played, with or without a request, e.g., in healthcare professional waiting rooms, pharmacies etc. Interactive electronic databases are defined as electronic information systems that provide menus through which the consumer can control the level of information detail accessed upon request, e.g., drug store kiosks, Internet. The circumstances under which information about drugs disseminated by videos and interactive electronic databases may or may not be advertising are similar to those specified for consumer brochures and Patient Support Group literature.

Continuing Medical Education (CME)/Scientific Symposia/Exhibits CME events and scientific symposia related to drugs are sometimes sponsored by pharmaceutical manufacturers. Such activities may not be advertising when they provide a forum for exchange of information on related clinical and scientific issues. The key factor in determining the status of such an activity is the degree to which the programme is independent of the drug manufacturer. The information may be nonpromotional in the following circumstances: !

sponsorship by a drug manufacturer is not targeted to specific aspects of the agenda,

!

the sponsor's role is adequately disclosed,

!

the programme is directed to scientists and/or health professionals,

!

the programme allows for exchange of information/debate,

!

the content of the agenda is not influenced by the sponsor,

!

the content of an individual presentation is not influenced by the sponsor where it concerns a drug manufactured by that sponsor,

!

there is no inducement provided to participants,

!

there are no ancillary commercial or promotional activities relating to drug products,

!

the limitations of the data and of the drug are adequately discussed,

!

discussion of an unauthorized drug or indication for use includes a statement indicating that the drug/indication has not been authorized for marketing in Canada, and

!

no reference is made to the availability of unauthorized drugs through the Special Access iv

Programme. Such an activity may be advertising where any of the aforementioned conditions are not met or where other factors indicate that the primary purpose of the activity is to promote the sale of a specific drug. Moreover, reports, edited scripts or recorded videos of the proceedings, in whole or in part, that concern a specific drug may be advertising if they are disseminated by the sponsor, or the sponsor's agent, to a wider audience after the meeting.

International Conferences The considerations described above for scientific symposia also apply to international medical/scientific conferences held in Canada. However, in the context of an international conference, display of a drug product prior to market authorization in Canada, or a product that is labelled for a use that has not been authorized in Canada, may be a nonpromotional activity in the following circumstances: !

the conference must clearly be an international event, e.g., a significant proportion of the conference delegates are from other jurisdictions,

!

the material must emanate from the parent company of the manufacturer,

!

the material must only be for use within the confines of the conference, and

!

the material is prominently identified as not being authorized for sale in Canada.

Help Seeking Announcements Help seeking announcements are defined as announcements that ask patients among the general public having a particular medical disorder, or that experience a given set of symptoms, to consult a physician for discussion of treatment, or to call a 1-800 telephone number for further information. Such an announcement may be a nonpromotional activity in the following circumstances: !

no specific drug is identified,

!

there is no implication that a drug is the sole treatment available for the disease or condition, and

!

no drug manufacturer's name is included.

!

Such an activity may be advertising where any of the aforementioned conditions are not v

met, or where other factors indicate that the primary purpose is to promote the sale or disposal of a drug. 1-800 Telephone Numbers Information provided by the sponsor to a member of the general public in response to a call placed on a 1-800 line set out in a help-seeking announcement may be a nonpromotional activity, in the following circumstances: !

the content is disease related rather than product related,

!

the various treatment options (drug and nondrug) and their respective risks and benefits are discussed in an objective manner,

!

no emphasis is placed on one drug product, e.g., excessive use of a brand name or description as a " breakthrough", and no emphasis is accorded to the merits of one drug product,

!

no reference is made to an unauthorized drug beyond the mention that research is underway in a particular area, in which case, the regulatory status should be indicated (i.e., market authorization not yet obtained), and

!

no reference is made to the availability of unauthorized drugs through the Special Access Programme.

Information supplied pursuant to a call placed on the 1-800 telephone line may be advertising where any of the aforementioned conditions are not met or where other factors indicate that the primary purpose is to promote the sale of a drug.

Unsolicited Requests for Information Information provided to an individual about a drug treatment(s) by a pharmaceutical manufacturer in response to a request for information that has not been solicited in any way (by the manufacturer of the drug) is not considered to be advertising for the sale of a drug.

Journal Supplements/Inserts Journal supplements are usually comprised of a collection of articles that deal with related issues or topics, are published as a separate issue of the journal, or as a second part of a regular issue, and are funded by sources other than the journal publisher, e.g., by the pharmaceutical manufacturer. Where publication is sponsored, in whole or in part, by a drug manufacturer, it may be a nonpromotional activity in the following circumstances: vi

!

the content of the insert comprises unedited symposium proceedings that address a variety of issues relating to different disease entities or drug treatments,

!

the content of the insert reports on a variety of treatment approaches for the same medical condition,

!

the publication is targeted to its customary readership,

!

no link is established between conventional advertising and the articles, e.g., by proximity,

!

sponsorship by the pharmaceutical manufacturer is declared in such a way that there is no obvious link to a drug discussed, and

!

the supplement is identified in such a way that it is distinct from the regular journal edition.

In contrast, a journal supplement may be advertising where the aforementioned conditions are not met and where other factors indicate that the primary purpose of the publication is to promote the sale of a drug, for example: !

the supplement, in whole or part, is disseminated by the sponsor rather than by the publisher of the journal itself,

!

the publication or an article contained in it is edited by the sponsor, or

!

a conventional advertisement is placed in close proximity to an article discussing an unauthorized use for the same chemical entity/drug product.

Clinical Trial Recruitment An announcement that is intended to assist in the recruitment of patients or clinical investigators for a clinical trial, including an Open-label or Treatment IND, may be a nonpromotional activity in the following circumstances:

!

the intent of the announcement is clearly identified as being for recruitment of clinical trial participants,

!

the announcement indicates the patient profile required (the disease/symptoms to be treated, age, etc.),

!

the announcement includes a telephone number for obtaining further information that is related only to the clinical trial, and

vii

!

in the case of patient recruitment, no reference is made to the drug manufacturer's name, or to the name of the drug under investigation.

In contrast, an announcement used in the recruitment of clinical trial participants (patient and investigator) may be advertising where any of the aforementioned conditions are not met, or where other factors indicate that the primary intent of the announcement is to promote the sale of a drug, for example: !

the announcement makes claims respecting the safety and efficacy of the drug, or

!

the announcement draws a comparison with other treatments.

Formulary Kits Formulary kits are defined as material prepared for review by pharmaceutics and therapeutics and formulary committees, on which a decision to include a drug product in a formulary may be based. Such information may not be advertising provided the information is limited to that which would normally be required to support such an application. Where such an information package is disseminated, in whole or part, to a wider audience simultaneously, or at a later date, it may be advertising to promote the sale of the drug concerned.

Institutional Messages An institutional message is defined as a communication (e.g., brochure, published article, prospectus, annual report, etc.), which provides information about a pharmaceutical manufacturer, or other institution, concerning its philosophy, activities, product range (by name), financial details, area of future development or research, etc. Such a message may be a nonpromotional activity in the following circumstances: !

the purpose of the communication is clearly to provide information about the institution rather than about the drugs being marketed, developed or researched,

!

information about the drugs being marketed, developed or researched is limited to the name and therapeutic use of the drug, and

!

no emphasis is given to any one or more products, or their benefits.

Reference texts, Peer-reviewed Journal Articles

Dissemination of full, unedited reference texts (textbooks, chapters of textbooks), government publications or reprints of published, peer-reviewed articles from medical or viii

scientific journals, that are identified as being provided courtesy of a pharmaceutical manufacturer, may be a nonpromotional activity provided that: !

no link between the text and promotion of a drug is established by the manufacturer.

Such material may be considered to be advertising where the aforementioned condition is not met or where other factors indicate that the primary purpose is to promote the sale of a drug, for example: !

the material is accompanied by any form of additional information (e.g., printed, word of mouth) designed by or on behalf of the manufacturer for the purpose of promoting a drug (e.g., detail aid),

!

the material was written or edited by an employee or agent of the pharmaceutical manufacturer,

!

a summary or interpretation of the text prepared by the pharmaceutical manufacturer or his agent accompanies the material,

!

reference is made to the availability of an unauthorized drug through the Special Access Programme.

ix

Therapeutic Products Directorate Medical Devices Bureau 150 Tunney’s Pasture Driveway Room 1605 Main Building Tunney's Pasture Address Locator: 0301H1 Ottawa, Ontario K1A 0K9 December 14, 2009 File number: 09-137496-189 To: Hospital Administrators, Hospital Risk Managers, Hospital Infection Control Practitioners, Hospital Purchasing Departments, Hospital Biomedical Engineering Departments, Provincial and Territorial Ministries of Health Subject: Purchase of Licensed Medical Devices for Use in Healthcare Facilities This letter is being sent to remind health care facilities and practitioners that medical devices imported or purchased for use in health care facilities must comply with the Canadian Medical Devices Regulations (Regulations). Class II, III or IV medical devices require authorization by Health Canada (by way of a device licence) before they can be legally imported and sold in Canada. In contrast to licensed devices, unlicensed devices have not undergone any assessment by Health Canada as to their safety, quality or effectiveness. Facilities who import and purchase unlicensed devices may place the health and safety of their staff and patients at risk. Health Canada asks that all health care facility staff responsible for purchasing medical devices have relevant knowledge of the requirements of the Regulations. Informing staff of regulatory requirements will help to assure that your health care facility complies with all applicable requirements. The Medical Devices Regulations may be obtained on the following Web page: http://laws.justice.gc.ca/en/f-27/sor-98-282/text.html. In brief, Section 26 of the Regulations prohibits the importation and sale, including offering for sale by way of advertisement, of a Class II, III or IV medical device, unless the manufacturer of the device holds a medical device licence. Health Canada advises that medical devices that are not licensed for sale in Canada should not be purchased by health care facilities. An exception to the above exists in the case of Class III or IV custom-made devices, medical devices for special access, and medical devices for the purpose of conducting investigational testing. Importation or sale under these circumstances is possible if the relevant sections of the Regulations are met and Health Canada has granted authorization. .../2

-2-

Advertising Class II, III or IV medical devices for sale prior to obtaining a medical device licence is prohibited. A manufacturer’s response to a Request for Proposal (RFP) is also considered to be an “offer for sale;” therefore, if a manufacturer responds to a RFP with a submission of an unlicensed medical device, it would be in contravention of the Regulations. Before entering into any contractual agreement with a manufacturer, we strongly recommend that health care facilities verify that the medical device is licensed by Health Canada. Information on licensed devices can be obtained from the Medical Devices Active Licence Listing (MDALL) available on the Health Canada Web site at www.mdall.ca. This Web site also includes a licence history archive containing devices that were previously licensed for sale and are no longer active. Further information on the importation, sale, advertising, and licensing requirements of the Medical Devices Regulations maybe obtained on the following Web page: http://www.hcsc.gc.ca/dhp-mps/md-im/index-eng.php If a healthcare facility has a question or concern regarding the licensing status of a medical device they should contact the Medical Devices Bureau at 613-957-4786. Yours sincerely,

Original signed by Roland Rotter, Director, Medical Devices Bureau

Health Products and Food Branch Inspectorate Graham Spry Building, 3rd Floor 250 Lanark Avenue Address Locator #2003D Ottawa, Ontario K1A 0K9 August 22, 2008

08-120519-655

To: ALL INTERESTED PARTIES I am pleased to inform you that the document entitles “Guidance on Medical Device Compliance and Enforcement” (GUI-0073) is now available on the Compliance and Enforcement section of Health Canada’s website under “What’s New”. This guidance document states requirements and responsibilities that should be achieved by all parties in accordance with the regulatory requirements of the Food and Drugs Act (the Act) and Medical Device Regulations regarding compliance and enforcement of medical devices in Canada. This guide “Guidance on Medical Device Compliance and Enforcement” replaces the policy aspect of the current POL-0045 document entitles “Medical Device Compliance and Enforcement Directive” published in March 2004, which contains both policy and guidance elements. This Guidance document has currently been developed to update and augment the Compliance and Enforcement Procedures. Inquiries about this document can be address to the Medical Device Compliance Unit, Fax 613954-0941 or by e-mail [email protected] .

Yours truly,

Original signed by Kim Dix for Diana Dowthwaite Director General

OUR MANDATE: To p romote good nutrition and informed use of drugs, food, medical devices and natural health products, and to maximize the safety and efficacy of drugs, food, natural health products, medical devices, biologics and related biotechnology products in the Canadian marketplace and health system.

Health Products and Food Branch Inspectorate Guidance on Medical Device Compliance and Enforcement GUI-0073 Supersedes: March 1st, 2004 (replacing POL-0045) Date issued: August 22, 2008 Date of implementation: August 22, 2008 Disclaimer This document does not constitute part of the Food and Drugs Act (Act) or the Food and Drugs Regulations (Regulations) and in the event of any inconsistency or conflict between that Act or Regulations and this document, the Act or the Regulations take precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the Regulations and the applicable administrative policies. This document is not intended to provide legal advice regarding the interpretation of the Act or Regulations. If a regulated party has questions about their legal obligations or responsibilities under the Act or Regulations, they should seek the advice of legal counsel. Ce document est aussi disponible en français.

Health Canada / Health Products and Food Branch Inspectorate

TABLE OF CONTENTS 1.0 Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 3 2.0 Mandate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 3 3.0 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 3 4.0 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 4 5.0 Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 5 5.1 Policy Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 5 5.2 Guiding Principles for Compliance and Enforcement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 5 5.2.1 Transparency and Fairness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 5 5.2.2 Risk Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 6 5.3 Responsibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 6 5.4 Response to Noncompliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 6 5.4.1 Noncompliance with Device Licensing or Authorization Requirements (Sections 26, 70 or 80) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 7 5.4.2 Establishment Licensing (EL) Noncompliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 9 5.4.2.1 Importation and Sale in Contravention of Section 44 . . . . . . . . . . . . . . . . . . . . . Page 9 5.4.2.2 Refusal to Issue an Establishment Licence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 9 5.4.2.3 Suspension of an Establishment Licence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 10 5.4.2.4 Failure to Renew an Establishment Licence and Cancelled Licences . . . . . . . Page 11 5.4.3 Noncompliance with Stop Sale for Class I Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 11 5.4.4 Noncompliance with Device-Specific Requirements Other than Device Licensing, Authorization or Stop Sale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 11 5.4.5 Noncompliance with Company-Specific Requirements Other than Establishment Licensing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 12 5.5 Enforcement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 12 6.0 Effective Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 13 7.0 Associated Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 13

Guidance on Medical Device Compliance and Enforcement (GUI-0073) / August 22, 2008

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Health Canada / Health Products and Food Branch Inspectorate

1.0 Purpose The purpose of this document is to provide the medical device industry with a clear description of compliance and enforcement actions relating to the Medical Devices Regulations (Regulations) and sections of the Food and Drugs Act (Act) applicable to medical devices. 2.0 Mandate The Inspectorate is responsible for managing the national compliance and enforcement program for medical devices. This program has an establishment licensing component, a proactive inspection component and a responsive compliance verification/investigation component. 3.0 Scope This document is applicable to any situation of noncompliance with the requirements of the Regulations or a section of the Act applicable to medical devices. The main areas of the Regulations are listed below. Part 1 - General 1. Safety and Effectiveness Requirements (sections 9-20) 2. Labelling Requirements (sections 21-23) 3. Contraceptive Device Advertising (section 24) 4. Stop Sale of Class I Medical Devices (section 25) 5. Device Licensing Requirements (sections 26-43) 6. Establishment Licensing Requirements (sections 44-51) 7. Distribution Records Requirements (sections 52-56) 8. Complaint Records Requirements (section 57) 9. Complaint Handling Procedure Requirements (section 58a) 10. Recall Procedure Requirements (section 58b) 11. Mandatory Problem Reporting Requirements (sections 59-61) 12. Recall Notification Requirements (sections 63-65) 13. Implant Registration Requirements (section 66-68) Part 2 - Custom-made and Special Access Devices 1. Authorization Requirements (section 70-74) 2. Labelling Requirements (section 75) 3. Distribution Records Requirements (section 76) 4. Incident Reporting (section 77) 5. Implant Registration Requirements (section 78)

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Health Canada / Health Products and Food Branch Inspectorate

Part 3 - Devices for Investigational Testing involving human subjects 1. Authorization Requirements (section 80, 82-85) 2. Record Requirements (section 81) 3. Labelling Requirements (section 86) 4. Advertising Requirements (section 87) 5. Distribution Records Requirements (section 88) 6. Recall Procedure Requirements (section 88) 7. Complaint Handling Requirements (section 88) 8. Mandatory Problem Reporting Requirements (section 88) 9. Recall Notification Requirements (section 88) 10. Implant Registration Requirements (section 88) Part 4 - Export Certificates 1. Export Certificate (section 89) 2. Signature (section 90) 3. Records (section 91) 4. Retention Time (section 92) This document also applies to those sections of the Act which apply to medical devices, including sections 3, 19, 20 and 21. 4.0 Definitions COMPANY: any regulated party subject to the Food and Drugs Act and the Medical Devices Regulations, including manufacturers, importers, distributors, persons, partnerships and associations. COMPLIANCE: the state of conformity of a regulated party (including a corporation, institution, individual or other legal entity) or a product with a legislative or regulatory requirement or a recognized standard. DISTRIBUTOR: a company, other than a manufacturer, an importer or a retailer who sells a medical device in Canada for the purpose of resale or use, other than for personal use. A person outside of Canada selling medical devices into Canada is also considered to be a distributor. ENFORCEMENT ACTIVITIES: the range of actions that may be taken to induce, encourage or compel observance of the Act and the Regulations.

Guidance on Medical Device Compliance and Enforcement (GUI-0073) / August 22, 2008

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Health Canada / Health Products and Food Branch Inspectorate

IMPORTER: a person, other than the manufacturer of a device, who causes the medical device to be brought into Canada for sale or for use, other than for personal use. MANUFACTURER (as per the Regulations): means a person who sells a medical device under their own name, or under a trade-mark, design, trade name or other name or mark owned or controlled by the person, and who is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the device, or for assigning to it a purpose, whether those tasks are performed by that person or on their behalf. NONCOMPLIANCE: a state of nonconformity with a specific requirement of the Act or Regulations. RECALL: in respect of a medical device that has been sold, means any action taken by the manufacturer, importer or distributor of the device to recall or correct the device, or to notify its owners and users of its defectiveness or potential defectiveness, after becoming aware that the device (a) may be hazardous to health; (b) may fail to conform to any claim made by the manufacturer or importer relating to its effectiveness, benefits, performance characteristics or safety; or (c) may not meet the requirements of the Act or these Regulations. 5.0 Policy 5.1 Policy Statement Where noncompliance with the requirements of the Regulations or the Act is identified, the Inspectorate ensures that appropriate actions are taken by the company to address the noncompliance, based on the risk to health. If appropriate actions are not taken to comply with the requirements, the company is subject to enforcement action. 5.2 Guiding Principles for Compliance and Enforcement The guidance document on compliance and enforcement for medical devices is based on the guiding principles and responsibilities outlined in the “Compliance and Enforcement Policy (POL-0001), Version 2”, found on the Inspectorate web site. 5.2.1 Transparency and Fairness For the requirements of the Regulations listed below, this document identifies uniform and predictable actions which are considered appropriate responses to noncompliance with: 1.

requirement for device licensing or authorization (sections 26, 70 or 80),

2.

the requirement for establishment licensing, and

Guidance on Medical Device Compliance and Enforcement (GUI-0073) / August 22, 2008

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Health Canada / Health Products and Food Branch Inspectorate

3.

the requirement to stop sale of a class I device.

For other requirements of the Act or Regulations, this document presents guidelines for developing actions which are considered appropriate responses to noncompliance with: 1.

device specific requirements other than licensing, authorization or stop sale, and,

2.

company specific requirements other than establishment licensing.

Where justified by circumstances and supported by sound rationale, the Inspectorate may consider alternate actions or approaches to those specified in this document. 5.2.2 Risk Management The degree and timeliness of actions to address noncompliance and any subsequent enforcement actions conducted by the Inspectorate are primarily based on the mitigation of risk to health. Noncompliance with the requirements of the Regulations or the Act may directly affect the safety and effectiveness of a device or group of devices; for example, failure of a device to comply with the requirement to provide adequate directions for use can present a health risk. Health Canada relies on the premarket review process to provide a level of assurance with respect to the safety, effectiveness, and compliance of class III and IV devices prior to permitting their sale in Canada. Noncompliance with device licensing or authorization requirements presents a potential risk to health. Failure to licence devices circumvents the premarket review required in the Regulations. Failure to comply with postmarket requirements, such as complaint investigation or recall reporting, may also pose a risk to health. The principal mechanisms the Regulations use to provide assurance of compliance with these requirements are device licensing for manufacturers and establishment licensing of importers, distributors and manufacturers of class I devices. Noncompliance with either device or establishment licensing requirements creates the potential that companies may not be able to adequately identify or take appropriate corrective action regarding unsafe or ineffective devices which they have manufactured, imported or distributed. 5.3 Responsibility As indicated in POL-0001, where noncompliance is brought to the attention of a company by the Inspectorate or otherwise, it is the company’s responsibility to take timely and appropriate action to comply. Where the action taken is considered inadequate to resolve the noncompliance, the Inspectorate may initiate enforcement actions. The enforcement actions have the primary objective of mitigating the risk associated with the noncompliance. 5.4 Response to Noncompliance Guidance for actions to be taken to respond to noncompliance have been divided into the following five groups: Guidance on Medical Device Compliance and Enforcement (GUI-0073) / August 22, 2008

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Health Canada / Health Products and Food Branch Inspectorate

1.

the requirement for device licensing (DL) or authorization (sections 26, 70 or 80),

2.

the requirement for establishment licensing (EL),

3.

stop sale for class I devices,

4.

device specific requirements other than licensing, authorization or stop sale, and

5.

company specific requirements other than establishment licensing.

5.4.1 Noncompliance with Device Licensing or Authorization Requirements (Sections 26, 70 or 80) This section applies to: 1.

devices subject to device licensing which have never been issued a licence (other than devices subject to Parts 2 or 3 of the Regulations),

2.

licensed devices which have been subject to change requiring an amendment under sections 34(a), (b) or (f) and have not been issued an amended licence,

3.

devices which have had their licence suspended or cancelled, and

4.

devices being imported or sold under the special access, custom-made, or investigational testing provisions of the Regulations (Parts 2 or 3) which require an authorization and have not received one or have had it cancelled.

Requirement to stop noncompliant activity When the Inspectorate has evidence that a medical device has been sold or imported without complying with the requirements of sections 26, 70 or 80 of the Regulations, the Inspectorate issues notice to the company who has imported or sold the unlicenced or unauthorized device. The notice directs the company to immediately stop importation/sale of the device in Canada. This notice may be issued onsite during an inspection or by letter in the case of other compliance activities. If the company is not the manufacturer of the device, the Inspectorate will issue notice to the manufacturer of the device to stop sale of the device in Canada. Requirement to notify customers In the stop sale notice issued to a manufacturer, the Inspectorate will also require that the manufacturer provide written notification to anyone to whom they have sold the device. The notification of customers must be in writing and clearly indicate the device has been imported or sold in contravention of the Medical Devices Regulations and clearly direct recipients to stop any further sale or distribution of the affected devices. The notification to customers is considered to be a recall action and the company must submit section 64 and 65 information in accordance with the Regulations. The recall action should proceed to the end user level if necessary. Importers and distributors receiving the notification from the manufacturer should also notify their customers. Their notification to customers should direct recipients to stop sale and notify anyone to whom they have sold the device (unless distribution records are not available as in the case of a retailer). Importers are also required to comply with sections 64 and 65 of the Regulations. Guidance on Medical Device Compliance and Enforcement (GUI-0073) / August 22, 2008

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For licences which have been suspended, cancelled or are subject to amendment, the notification is required to be sent to anyone who has imported or has been sold the device after the cancellation or suspension date, or after the date when the amendment was required. When noncompliances related to sections 26, 70 or 80 are found, companies may be asked to review other devices they manufacture, import or sell and provide evidence of compliance with licensing and authorization requirements. Requirement for confirmation of actions taken For noncompliances identified during an inspection, confirmation of stop importation and sale is required by the closing meeting. If no confirmation is received, the Inspectorate may take enforcement action to prevent further noncompliant activity. Stop importation/sales issued during an inspection will be listed in the inspection summary section of the inspection report. For stop importation and sale notices issued to a manufacturer, importer or distributor by letter, written confirmation, on the included fax-back form, is required from the company within 5 business days that they have stopped the importation or sale of the affected devices. A copy of their notification and the distribution list must accompany the confirmation. If written confirmation that importation or sale was stopped upon receipt of a stop importation/sale letter is not received within 5 business days, enforcement actions will be initiated in accordance with POL-0001. Request to delay notification In the following circumstances, a company may request that notification of clients be delayed pending the issuance of the required licence, amendment or authorization. Requests for the delay of notification will be reviewed by the Operational Centre responsible for the company. 1. The device in question is class II and the manufacturer can demonstrate that they currently hold device licences. If a delay is granted, the manufacturer must supply evidence that they have applied for a device licence within 5 business days after the stop sale notice was issued. The evidence must include a copy of the quality system certificate which accompanied the application. If the device is not covered under the scope of the certificate, the delay will be cancelled and notification will be required. 2. The noncompliance can be addressed through a licence amendment, which meets the criteria for a fax-back process. If a delay is granted, the manufacturer must supply evidence that the fax-back amendment was sent within 5 business days after the stop sale notice was issued. 3. The device qualifies for licensing under the policy for private label manufacturers. If a delay is granted, the manufacturer must supply evidence that they have applied for a device licence within 5 business days after the stop sale notice was issued. If the application does not contain all the documentation required under the policy, the delay will be cancelled and notification will be required.

Guidance on Medical Device Compliance and Enforcement (GUI-0073) / August 22, 2008

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Health Canada / Health Products and Food Branch Inspectorate

If delays are granted in any of the above circumstances, manufacturers are required to notify the Inspectorate when they receive notification of the outcome of their licensing application. Notification will not be required if the licence or amended licence is issued. If the application is refused, the company will be required to go ahead with notification. Other actions For devices which, 1) are unlicensed or unauthorized, and present a health risk owing to the contravention of other requirements of the Regulations such as safety and effectiveness, or 2) have had their licence suspended owing to failure to meet safety and effectiveness requirements, the company should take additional action to mitigate the risk in accordance with section 5.4.4. This may include a removal of the device from the market or a public advisory. Health Canada may also issue public notices for devices which are not in compliance with device licensing, or Part 2 or 3 authorization requirements. 5.4.2 Establishment Licensing (EL) Noncompliance 5.4.2.1 Importation and Sale in Contravention of Section 44 Where a company imports or sells a medical device without complying with the requirement in section 44 to hold an establishment licence, the Inspectorate issues a written notice to the company advising that these activities must cease until they apply for and receive an establishment licence. They are required to provide a response in writing within 5 business days of the date of the notice. If a satisfactory response is not received within 5 business days and/or application for an establishment licence has not been initiated, a warning letter is issued to the company reiterating the noncompliance and the actions to be taken by the company. A response is required within 5 business days. If a satisfactory response to the warning letter is not received within 5 business days, the company will be subject to appropriate enforcement action as allowed for under the Act and Regulations. 5.4.2.2 Refusal to Issue an Establishment Licence Establishment licences will be refused if there are reasonable grounds to believe that issuing such a licence would constitute a risk to the health or safety of patients, users or other persons. Failure to comply with any requirements of the Act or Regulations which may impact on health and safety may be considered such grounds. The letter of refusal identifies the reason for the refusal. The applicant company may seek an opportunity to be heard but may not initiate any importation or sale subject to section 44 while waiting to be heard. 5.4.2.3 Suspension of an Establishment Licence An establishment licence may be suspended when one or more of the following conditions are present:

Guidance on Medical Device Compliance and Enforcement (GUI-0073) / August 22, 2008

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Health Canada / Health Products and Food Branch Inspectorate

1.

evidence that the company has failed to comply with the requirements of the Act or Regulations,

2.

evidence the company made a false or misleading statement in the application, or

3.

allowing the company to continue activities subject to EL would constitute a risk to the health and safety of patients, users or other persons.

Where the Inspectorate becomes aware that one or more of the above conditions exists, the company is normally given an opportunity to submit and implement a corrective action plan. This opportunity may be denied where immediate action is required to protect health and safety. If the company fails to respond or the response is inadequate, the company is subject to establishment licence suspension. Companies subject to establishment licence suspension are issued a letter of intent indicating that a recommendation has been made to the Director General of the Inspectorate that the licence be suspended under section 49 or 50 of the Regulations. Suspension under Section 49 The letter of intent identifies the reason for the proposed suspension, any corrective action required to be taken and the time within which it must be taken. If the proposed suspension is based on the outcome of an inspection or a failure to respond to corrective actions arising from the inspection, this will be referenced in the letter. Suspension under Section 50 If a licence suspension is required to prevent injury to the health or safety of patients, users or other persons, a recommendation may be made to suspend the licence under section 50. This recommendation is submitted by an Operational Centre Manager for approval by the Inspectorate Director General. If approved, a Notice of Suspension is issued without an opportunity for the company to be heard. Activities subject to EL must stop effective the date of suspension. However, the company may request, in writing, that the licence suspension be reconsidered. Within 45 days of such a request, the company is given an opportunity to be heard. The company may not resume activities subject to EL pending the outcome of the hearing. The licence may be reinstated if the situation giving rise to the suspension has been corrected or the reason for suspension was unfounded. Companies who fail to comply with a suspension notice are subject to immediate enforcement action. 5.4.2.4 Failure to Renew an Establishment Licence and Cancelled Licences Companies who fail to renew their establishment licence or request that their licences be cancelled because they are no longer subject to the establishment licensing requirements are advised in writing that they must immediately stop all activities subject to EL. They are required to confirm in writing within 5 business days that they have taken this action.

Guidance on Medical Device Compliance and Enforcement (GUI-0073) / August 22, 2008

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If confirmation is not received or there are reasonable grounds to believe activities subject to EL are still occurring, a compliance inspection may be conducted to determine if the company is noncompliant. If activities subject to EL are confirmed, the company is subject to immediate enforcement action. 5.4.3 Noncompliance with Stop Sale for Class I Devices Any manufacturer not complying with directions to stop sale under sections 25 or 85(2)(a) of the Regulations is subject to immediate enforcement action. These companies must also determine if the situation warrants a recall of devices, using the recall procedure required under section 58(b). The actions taken are reviewed by Health Canada to ensure they are adequate. 5.4.4 Noncompliance with Device-Specific Requirements Other than Device Licensing, Authorization or Stop Sale Where a company does not comply with requirements of the Act or Regulations which relate to a specific device or group of devices such as labelling or safety and effectiveness, the Inspectorate advises the company to take action based on the following guidelines: 1.

When the noncompliance might impact the safety or effectiveness of one or more devices, the Inspectorate advises the company to: a)

stop importation and sale of the affected devices until such time as compliance is achieved,

b)

take immediate action to assess the risk associated with the noncompliance and develop a strategy to mitigate the risk, which may include recall activities such as advisories, corrective action, or removal from use , and

c)

take preventive action to achieve and maintain compliance.

Note: The Inspectorate may request a health hazard evaluation or risk benefit analysis from the Medical Devices Bureau to assess risk. If the evaluation or analysis recommends specific actions to address the risk, the company is advised to take those actions. 2.

When noncompliance minimally impacts the safety and effectiveness of a device, the company is asked to provide and implement a corrective action plan for resolving the noncompliance in a timely and effective manner and for preventing recurrence.

Companies who fail to conduct such actions in a timely and effective manner are subject to enforcement action which may include the following; • a recommendation to the Medical Devices Bureau (MDB) for information requests under section 25 or 39, • a recommendation to MDB for suspension of a device licence under section 40 or 41 or • a recommendation to the Director General of the Inspectorate for suspension of an establishment licence, where applicable. Guidance on Medical Device Compliance and Enforcement (GUI-0073) / August 22, 2008

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Health Canada / Health Products and Food Branch Inspectorate

5.4.5 Noncompliance with Company-Specific Requirements Other than Establishment Licensing Where a company does not comply with a requirement of the Act or Regulations which relates to a procedure or action that they are responsible for (eg. they lack a recall procedure or they fail to submit mandatory problem reports) the Inspectorate advises the company to take action according to the following guidelines: 1.

Assess the risk associated with the noncompliance and determine what corrective action is required to mitigate it. The Inspectorate may request a health hazard evaluation or risk benefit analysis from the Medical Devices Bureau to assess risk and determine if the actions proposed by the company are adequate. For example, if a company is found to have inadequately investigated complaints, they must take immediate action to investigate any outstanding problems, assess the risks and conduct any actions required to address the risks which still remain. Similarly, companies who have failed to conduct recall actions in order to address unsafe, ineffective or noncompliant devices, must immediately take recall action for devices which could still be in distribution or use. In the case of a company failing to notify Health Canada of recalls or mandatory problem reports, the Inspectorate may request the company to supply the relevant records for a given time period, in order to assess that adequate action was taken by the company to carry out the recalls or in the case of mandatory reports, to investigate and address the problem.

2.

In addition to the corrective action, the company takes appropriate preventive action to achieve and maintain compliance.

Any company not able to take required corrective action owing to a lack of records, absent or deficient procedures, or is found to be unwilling to take such actions, is subject to enforcement action focussed on addressing the risk to health. Enforcement actions may include suspension of establishment licence and recommendation to suspend device licences, where applicable. 5.5 Enforcement In general, companies are given an opportunity to take action in response to noncompliance. However, enforcement may be taken at any time during or after an investigation or inspection, where warranted by circumstances such as lack of cooperation or an inability to address the noncompliance. Failure of companies to respond to: 1. 2. 3.

written notices, inspection reports, or letters advising compliance actions such as recalls,

Guidance on Medical Device Compliance and Enforcement (GUI-0073) / August 22, 2008

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is interpreted as an indication that the company does not intend to voluntarily comply and that enforcement action is required. Companies with a history of failure to provide adequate response to noncompliance(s) may be subject to immediate enforcement action. Note: For the purposes of this document the timeframe listed for response to a written notice from the Inspectorate is deemed to start from the date of the notice. Enforcement actions are based on evidence of contravention of the Regulations or section of the Act applicable to medical devices. They may also include contravention of sections of the Act relating to an inspection, including section 23(3) of the Act which requires that inspectors shall be given reasonable assistance and be furnished with any information they may reasonably require. The enforcement actions may include, but are not limited to, warning letters, public notifications or Safety Alerts, product seizure, recommendation for actions under sections 25 or 39, recommendation for device licence suspension, establishment licence suspension, import refusal, injunction or prosecution. The Inspectorate applies enforcement actions based on risk to health and considers various factors including the types and classification of the devices involved, population at risk, degree of noncompliance and the company history in responding to noncompliance. 6.0 Effective Date August 22, 2008 7.0 Associated Documents HPFBI Compliance and Enforcement Policy, POL-0001 HPFBI Formal Hearing, Prosecution and Injunction Policy, POL-0006 HPFBI Seizure Policy, POL-0007 Medical Devices Regulations, SOR/DORS/98-282, as amended. Food and Drugs Act

Guidance on Medical Device Compliance and Enforcement (GUI-0073) / August 22, 2008

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BIOGRAPHIES

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BIOGRAPHY

Timothy M. Squire Partner Toronto Direct Line: +1 416 868 3462 Facsimile: +1 416 364 7813 [email protected] www.fasken.com/timothy-squire

Areas of Practice Technology and Intellectual Property Intellectual Property Life Sciences

Education L.L.B., University of Windsor, 1995 B.A., University of Windsor, 1992

Timothy Squire is a partner in the Toronto office and Chair of the Ontario Region Life Sciences Group. His practice is devoted to the regulation and commercialization of drug products, medical devices, natural health products and other types life science innovation. Tim brings a unique perspective to the firm's Life Sciences Group given his considerable knowledge and experience across the entire health product lifecycle. Tim has become a trusted advisor to many large and small drug and device manufacturers with operations in Canada. He also performs in-house legal functions for several U.S. and international clients without Canadian in-house legal or regulatory capabilities, and in this capacity has developed a comprehensive understanding of the business issues and pressures facing companies in the life sciences industry. Tim’s regulatory practice covers all aspects of health product regulation, including clinical trials and good clinical practices, market authorization, special access programs, the operation and application of the Patented Medicine (Notice of Compliance) Regulations, data protection under the Food and Drug Regulations, quality management, site and establishment licensing, packaging and labeling, promotion and advertising, product recalls and adverse event reporting, pricing and mandatory price reporting, provincial drug benefit plans including formulary eligibility and listing, and interacton with regulators throughout the product lifecycle including responses to government audits and enforcement actions. Tim also crafts corporate policies which implement a wide range of regulatory requirements, as well as corporate ethics and anti-corruption policies. In addition to his regulatory expertise, Tim’s practice also involves the commercialization of health product innovation. Tim negotiates and drafts sophisticated intellectual property agreements (including licenses, technology and material transfer agreements, joint R&D agreements, funding agreements, and employee, consultant and content specific confidentiality agreements), distribution and service agreements, and manufacturing and associated quality agreements. Tim is also called upon to quarterback intellectual property and regulatory due diligence in complex domestic and cross-border share and asset purchase transactions involving drug and device companies and product lines, and to manage the transition of market authorizations, intellectual property assets and other regulatory matters post acquisition.

Year of Call Ontario, 1997

Tim works closely with other specialists at Fasken including corporate, tax, intellectual property, government relations, litgation and employment lawyers to provide clients in the life sciences industry with a complete range of integrated legal services.

Presentations 

Focus on Medical Devices, Life Sciences Group, November 17, 2011



Medical Devices in Canada: Hot Legal and Regulatory Issues, Life Sciences Group Seminar, April 6, 2010



Managing Intellectual Property in a Soft Economy, November 27, 2008

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Licensing Executives Society 2008 Annual Meeting, October 19-23 2008

1 VANCOUVER

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BIOGRAPHY Timothy M. Squire

Publications 

"Fasken Martineau's Life Sciences Newsletter", Life Sciences Newsletter, October 2009



"Regulatory - Health Products Alert", Technology and Intellectual Property Bulletin, August 2009



"Intellectual Property: The Year 2008 in Review", By the Intellectual Property Practice Group, February 2009

Memberships and Affiliations 

Canadian Bar Association

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Ontario Bar Association

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American Bar Association

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Metropolitan Toronto Lawyers Association

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Toronto Intellectual Property Group

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International Association for the Protection of Intellectual Property (AIPPI)

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Daniel Yoon Biography Daniel Yoon has been with the Medical Devices Bureau since 2008. His duties include providing regulatory information and advice to stakeholders, classifying medical devices, and screening applications and quality management certificates. Daniel received an Honours Bachelor's of Science in toxicology from the University of Toronto and a Certificate in Pharmaceutical Regulatory Affairs and Quality Operations from Seneca College.

I N S T I T U T E

VANCOUVER

CALGARY

TORONTO

OTTAWA

MONTRÉAL

QUÉBEC CITY

LONDON

PARIS

JOHANNESBURG