TRANSITION PLAN FOR THE IMPLEMENTATION OF MEDICAL DEVICE ACT 2012 (ACT 737) Seminar on MEDICAL DEVICE ACT 2012 (ACT 737) PICC, Putrajaya 28 June 2012

MEDICAL DEVICE CONTROL DIVISION, Ministry of Health Malaysia ● Level 5, Boulevard Plot 3C4, No 26, Persiaran Perdana, Precinct 3, 62675 Putrajaya● www.mdb.gov.my ● [email protected] ● Tel: 603-88850600 ● Fax: 603-88850759

OVERVIEW OF THE REGULATORY FRAMEWORK PRE-MARKET

PRE-MARKET ASSESSMENT Manufacturers of medical devices shall • ensure their products conform to EPSP • establish appropriate quality system for manufacturing their products • collect evidence of conformity

CAB verifies evidence of conformity

PLACEMENT ONMARKET

MEDICAL DEVICE REGISTRATION • Manufacturers (or LARs) apply to register medical devices & establishment license

ESTABLISHMENT LICENSING Importers/distributors shall • ensure compliance to GDP & advertising requirements • apply for establishment license to import/distribute medical devices

POST-MARKET

SURVEILLANCE & VIGILANCE Establishments shall • monitor safety & performance of products • carry out post-market obligations, eg complaint handling, FSCA, recall

USAGE & MAINTENANCE • Users shall use, maintain & dispose off medical devices appropriately • Users shall apply for permit to use/operate designated medical devices

MDA monitors compliance to requirements & takes appropriate actions in accordance with the provisions of the law Medical Device Control Division MINISTRY OF HEALTH MALAYSIA

RISK-BASED CLASSIFICATION & REGULATORY CONTROL • A classification of medical devices based on risk associated with the vulnerability of the human body, the technical design and the manufacture of the medical device  It uses a set of classification rules based on:  

Risk Level Low

B

LowModerate

C

HighModerate

D

High

D

Class A

C

B

A

Regulatory control



intended use duration of use (transient, short-term and long-term) part of human body (non-invasive or invasive with respect to body orifices, surgically invasive interventions, central circulatory system, central nervous system)

R

I

S

K

Device risk/class Medical Device Control Division MINISTRY OF HEALTH MALAYSIA

Device examples Simple surgical instruments, tongue depressor, liquid-in-glass thermometer, examination light, simple wound dressing, oxygen mask, stethoscopes, walking aids Hypodermic needles, suction equipment, anesthetic breathing circuits, aspirator, external bone growth simulators, hearing aids, hydrogel dressings, patient controlled pain relief, phototherapy unit, x-ray films Lung ventilator, orthopedic implants, baby incubator, blood oxygenator, blood bag, contact lens disinfecting/cleaning products, deep wound dressing, defibrillator, radiological therapy equipment, ventilator Pacemakers and their leads, implantable defibrillators, implantable infusion pumps, heart valves, inter-uterine contraceptive devices, neurological catheters, vascular prostheses, stents

CONFORMITY ASSESSMENT Conformity assessment (CA): Systematic examination of evidence generated and procedures undertaken by the manufacturer under the requirements established by the Regulatory Authority to determine that a medical device is safe and performs as intended by the manufacturer and, therefore, conforms to the Essential Principles of Safety and Performance for Medical Devices Medical Device Control Division MINISTRY OF HEALTH MALAYSIA

What To Look For In CA? Objective evidence for conformance to Essential Principles of Safety & Performance of Medical Device –  6 general principles  11 design and manufacturing principles

CONFORMITY ASSESSMENT Essential Principles of Safety & Performance of Medical Device General Principles Medical device should be designed & manufactured in such a way that:  no compromise to clinical condition or safety of patients, or safety and health of users or other persons  control the risk so that residual risk is brought down to an acceptable level  suitable for one or more of the functions within the scope of the definition of a medical device  characteristics and performances should not be adversely affected to such a degree that they compromise the health or safety of patient or user and other persons during the lifetime of the device  characteristics and performances during their intended use will not be adversely affected under transport and storage conditions  benefits must be determined to outweigh any undesirable side effects Medical Device Control Division MINISTRY OF HEALTH MALAYSIA

Design and Manufacturing Principles  Chemical, physical and biological properties  Infection and microbial contamination  Manufacturing and environmental properties  Devices with a diagnostic or measuring function  Protection against radiation  Requirements for medical devices connected to or equipped with an energy source  Protection against mechanical risks  Protection against the risks posed to the patient by supplied energy or substances  Protection against the risks posed to the patient for devices for self-testing or self administration  Information supplied by manufacturer  Performance evaluation including where appropriate, clinical evaluation

CONFORMITY ASSESSMENT Elements of CA  QMS (ISO 13485 or equivalent, GDPMD)  Post-market surveillance system (GHTF recommendations)  Summary technical documentation (ASEAN CSDT)  Declaration of conformity (DoC) (GHTF recommendations)  Registration of medical device & licensing of establishment Declaration of Conformity (DoC) • A DoC is a declaration made by the manufacturer of a device that the device is in conformity with the regulatory requirements • DoC declares that the manufacturer guarantees that each piece of the device sold is in conformity with the regulatory requirements

Summary Technical Documentation • Format – ASEAN CSDT • Compliance to EPSP (GHTF recommendations - Essential Principles of Safety & Performance of Medical Devices) • Acceptable standards or equivalence will be widely used (GHTF recommendations Role of Standards in the Assessment of Medical Devices) • CAB determines the adequacy of the documented evidence to support attestation of conformity

Medical Device Control Division MINISTRY OF HEALTH MALAYSIA

Quality Mgmt System (QMS) • For manufacturer, ISO 13845 or equivalent –Class A & B products, can exclude design control, process control, inspection & testing –For Class C, full QMS –For Class D, full QMS • PMS system • Technical evaluation of sterilization process (if any) • For LAR, importer, distributor: GDPMD Post-Market Surveillance System (PMS) • Distribution records • Complaint records • Adverse incident reporting (GHTF

recommendations - Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices) • FSCA reporting (GHTF recommendations - Medical Devices Post Market Surveillance: Content of Field Safety Notices)

CONFORMITY ASSESSMENT CA PROCESS & PARTIES INVOLVED Conformity assessment is primarily the responsibility of the medical device manufacturer. However, it is done in the context of the established regulatory requirements and both the process and conclusions are subject to further review by the Regulatory Authority Medical Device Control Division MINISTRY OF HEALTH MALAYSIA

Manufacturer conducts CA on; (i) QMS & PMS (ii) Product safety & performance (summary tech doc & DoC

CAB reviews evidence of conformity Authority reviews & registers product & licenses establishment

What is a CAB?  A body authorized by the Authority to perform specified CA activities to determine whether the relevant requirements in technical regulations or standards are fulfilled  CAB is independent of the organization that provides the product and is not a user of the product (3rd party)  Authority will monitor the performance of the CAB and, if necessary, withdraw authorization

C

Level of CA

R Class Class A, Class A(S) Class A(M) Class B Class C Class D

QMS

PMS system

Est & maintain – can excl design & dev control. Class A may be audited for special cases. For Class B, make available for audit

Establish & maintain adverse event reporting procedure for audit. For Class A, audit may be required to investigate specific safety or regulatory concerns

Establish, maintain full QMS make available for audit

Medical Device Control Division MINISTRY OF HEALTH MALAYSIA

B

A – Self declare

The level of CA is proportional to the risk associated with the device

I Tech doc CSDT

Prepare, make available upon request. For Class B may be reviewed for conformity to EPSP Prepare & submit for review

D – Product design & manufacturing control

CONFORMITY ASSESSMENT

S

K DoC

Registration & licensing

Prepare, sign & submit for review

Perform according to requirements

WHAT DO WE NEED TO IMPLEMENT THE REGULATORY SYSTEM? • • • •

Legal support, ie the Acts Subsidiary legislations & guidance documents Medical Device Authority & organization Registration & licensing system – – – – –

Internal processes & procedures Register, database & resource center Forms Criteria Procedures

Medical Device Control Division MINISTRY OF HEALTH MALAYSIA

MEDICAL DEVICE REGISTRATION ROUTES B, C, D

Stop

Conformity Assessment By CAB or MDA 1. 2.

No

Technical File ISO 13485 QMS

Stop

No

Medical device?

No

OK?

Qualified for abridged?

Yes

Evaluation

Decision

Yes Yes

Grouping: • Single • System • Kits • Group

Yes

B, C, D Class? A

r

1.Application Form 2. DC from Product Owner/Manufacturer 3.CSDT 4. Class B, C if Required- Clinical evidence Class C&D – Clinical Evaluation

Class A Sterile MD -ISO 13485 (In-House) -ISO 13485 (Sterile Services) -Process Validation (Report) Class A Measuring Function MD -Process Validation (Report) Class A 1.Application Form 2. Declaration of conformity 3. Certified QMS. If no, attestation by manufacturer Division 4. Simplified CSDT

Medical Device Control MINISTRY OF HEALTH MALAYSIA

Pay fee

MEDICAL DEVICE REGISTER

LICENSING OF ESTABLISHMENTS  Establishment means a person/organization who is either a manufacturer, authorized representative (for foreign manufacturer), importer or distributor of medical devices, but does not include a retailer  Different type of establishment has different roles & responsibilities – different set of control  Establishment must possess valid license to carry out activities related to medical devices in Malaysia Medical Device Control Division MINISTRY OF HEALTH MALAYSIA

Foreign manufacturer

Importer Authorized representative

Local manufacturer

Distributor

Distributor

Imported device

Locally-made device

Relationship between different establishments

LICENSING OF ESTABLISHMENTS Authorization: Appropriate authorization from the respective establishment is required as a pre-requisite for the issuance of license  Authorized rep must be authorized by foreign manufacturer  Importer must be authorized by authorized rep to import devices on its behalf  Distributor must be authorized by manufacturer/ authorized rep to distribute devices on its behalf  An entity may apply for license for different types of establishment Medical Device Control Division MINISTRY OF HEALTH MALAYSIA

Manufacturer as defined in Section 2 of MD Bill 2011: definition of “manufacturer” Authorized representative as defined in Section 2 of MD Bill 2011: definition of “manufacturer” • Authorized representative must be natural or legal person with business registration in Malaysia. • It must maintain linkage with its foreign manufacturer and should be able to obtain the support of its foreign manufacturer whenever required. Distributor: Any natural or legal person in the supply chain authorized by the manufacturer/authorized representative to further the availability of medical devices to the end-user. In some circumstances, more than one distributor may be involved in this process Importer: Any natural or legal person authorized by authorized representative, who first makes a medical device manufactured in other countries, available in the Malaysian market

LICENSING OF ESTABLISHMENTS Requirements • Establishment details • Appropriate authorization • Procedures for; – Distribution records – Complaint handling – Adverse incident reporting – Field safety corrective action • List of medical devices • ISO 13485 or equivalent

• Good Distribution Practice for Medical Devices (GDPMD) Medical Device Control Division MINISTRY OF HEALTH MALAYSIA

Local manufacturer

Authorized rep

Importer

Distributor

GDPMD FOR AUTHORIZED REP, IMPORTER & DISTRIBUTOR Foreign manufacturer

Local manufacturer

Local authorized representative

Importer

Distributor

Distributor

Imported medical devices Importer Medical Device Control Division MINISTRY OF HEALTH MALAYSIA

Locally-made medical devices Distributor

SAVINGS & TRANSITIONAL Section 80 of MD Act 2012 (Act 737): Savings and transition – All medical devices shall be registered within 24 months from the appointed date – All establishments shall be licensed within 12 months from the appointed date

Medical Device Control Division MINISTRY OF HEALTH MALAYSIA

CURRENT STATUS: THE ACT • MD Act 2012 (Act 737) & MD Authority 2012 (Act 738) – 3 Oct 2011: Passed by Lower House of Parliament – 7 Dec 2011: Passed by Upper House of Parliament – Already gazetted

Medical Device Control Division MINISTRY OF HEALTH MALAYSIA

CURRENT STATUS: ORGANIZATION • New statutory body setup: Medical Device Authority – early Q3 2012 • Human resource – already approved PSD MEDICAL DEVICE AUTHORITY (MDA) A body corporate with the following members - DG of Health as the Chairman - Chief Executive of the MDA - a representative of Min of Finance - a representative of Min of Health - not more than five persons appointed by the Minister, who have expertise and experience in medical device matters

Functions of MDA • To implement, enforce, consider and recommend reform to the medical device laws • To perform the following - to regulate all matters - to provide consultancy & advisory service and any other services in relation to medical device, its industries and activities • To utilize property of the Authority in such manner as the Authority may think expedient • To impose fees or charges for services rendered

Committees appointed by MDA - to assist in the performance of the functions of the Authority Medical Device Control Division MINISTRY OF HEALTH MALAYSIA

CURRENT STATUS: SUBSIDIARY LEGISLATIONS • MD (Pre-Market) Regulations – 1st phase: draft pre-market regulations is ready • Registration of MD – – – – – – – –

Classification Grouping Conformity assessment procedure Application procedure for registration Renewal of registration Changes concerning registered MD Exemption Cancellation of registration

• Registration CAB • Establishment license • Etc..

• • • • • •

Forms Fee structure Criteria Conditions Procedures Other details

– To be submitted to AG’s Chamber: August 2012 Medical Device Control Division MINISTRY OF HEALTH MALAYSIA

CURRENT STATUS: GUIDANCE DOCUMENTS Guidance Documents Awaiting publication

(i) Definition of Medical Device (ii) Risk Based Classification (iii) Essential Principles of Safety & Performance of Medical Device (iv) Common Submission Dossier Template (v) Good Distribution Practice for Medical Devices

Under development

(vi) IVD Medical Device Classification System (vii) Essential Principles of Safety and Performance for IVD Medical Devices (viii) Conformity Assessment for IVD Medical Devices (ix) Common Submission Dossier Template for IVD Medical Device

Medical Device Control Division MINISTRY OF HEALTH MALAYSIA

(i) Conformity assessment body (ii) Declaration of Conformity (iii) Guidelines for product registration (iv) Grouping of medical devices

REGISTRATION OF MEDICAL DEVICES  Medical device regulatory system is based on safety & performance of medical devices throughout their life cycle  Prior to registration of a medical device, CA is conducted to provide objective evidence of safety & performance a medical device  Only registered medical devices can be placed into the market  Establishments dealing with medical devices must comply with conditions and carry out their obligations Medical Device Control Division MINISTRY OF HEALTH MALAYSIA

 Who shall be responsible? – Licensed local manufacturers or authorized rep  What would be required? – Submission of CSDT – Submission of DoC – Establishment, maintenance and making available of QMS & PMS documents for audit  Upon approval, the medical device will be put in the Medical Device Register Abridged Assessment • Applicable for medical devices which have already approved by the relevant authority to be marketed in US, EU, Canada, Australia, Japan. • Otherwise, full assessment shall be done

CURRENT STATUS: MEDC@ST • New registration & licensing system

ESTABLISHMENT LICENSING MEDICAL DEVICE REGISTRATION CAB REGISTRATION COMPETENCY REGISTRATION SERVICE PROVIDER REGISTRATION Medical Device Control Division MINISTRY OF HEALTH MALAYSIA

MEDC@ST: ESTABLISHMENT LICENSING

Authorized representative

Medical Device Control Division MINISTRY OF HEALTH MALAYSIA

MEDC@ST: MEDICAL DEVICE REGISTRATION

Medical Device Control Division MINISTRY OF HEALTH MALAYSIA

MEDC@ST: MEDICAL DEVICE REGISTRATION

Medical Device Control Division MINISTRY OF HEALTH MALAYSIA

NOW TO MANDATORY PHASE Passing of MD & MD Authority Bills

Gazettement of MD & MD Authority Bills

Announcement of appointed dates of implementation MD & MD Authority Acts

Establishment of MD Authority

Appointed date of implementation of MD Act

Mandatory implementation MD Act

3-Oct-2011

30-Dec-2011

End Feb2 012

31-July-2012

31-Oct-2012

31-Oct-2014

Preparation & development of MD Act

Appointment of members of MD Authority

Preparation & development of computerized system

Appointment of Chief Executive of MD Authority

Preparation & development of subsidiary legislations

Transition of MD Control Div to assist in the establishment of MD Authority

Preparation & development of regulations, guidance documents & standards for the implementation of MD Act Medical Device Control Division MINISTRY OF HEALTH MALAYSIA

Licensing of Establishments

NOW TO MANDATORY PHASE Mandatory implementation of MD Act

Establishment of MD Authority

Gazettement of Bills

Passing of Bills

Q1

Q2

Q3

Phase 2: Imposition of GDP for other establishments Phase 1: Imposition of ISO13485 for manufacturers Phase 5: Registration of IVD

Registration of Products and CABs

Appointed dates of implementation MD Act

Phase 3: Imposition of other obligations

Q4

Q1

2011

Q2

Phase 4: Registration of Class B &C Phase 3: Registration of Class D Phase 2: Registration of CAB Phase 1: Registration of Class A Q3

2012

Voluntary Medical Device Control Division MINISTRY OF HEALTH MALAYSIA

Q4

Q1

Q2

Q3

Q4

Q1

2013

Q2

Q3

2014

Transition

Q4

Q1

Q2

Q3

2015

Mandatory

Q4

NOW TO MANDATORY PHASE

CAB guidance document (GD)

CAB registration system

CAB Registration System

Implementation of CAB registration Development of CAB registration system

Finalization of GD Comments of GD from interested parties

Development of GD

June Medical Device Control Division MINISTRY OF HEALTH MALAYSIA

July

August

September

October

SUMMARY • Regulatory framework & legal support are in place • Current status: Work is progressing – putting the detailed pieces together • Moving forward – regulatory activities will be introduced in phases, timeline • Awareness & consultations

Medical Device Control Division MINISTRY OF HEALTH MALAYSIA

….Thank you for your attention Medical Device Control Division MINISTRY OF HEALTH MALAYSIA