How to comply with Malaysia Medical Device Regulations 2012 ? Mourad Kholti Founder & Principal Consultant
March 5th 2014 – 12pm
Contents
Introduction Definitions Arrangement of the Medical Devices Regulations 2012 Schedules Summary Q&A 9/23/13
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Introduction
Malaysia Area 329,758 square km Population 28.3 million Capital city Kuala Lumpur Medical device market current growth is 9% per year, reaching US$1.9 billion, or US$61 per capita, by 2016.
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Introduction
Andaman Medical Bridge Sdn. Bhd. Based in Penang, Malaysia, AMB helps Medical Devices Manufacturers to develop clinical & regulatory strategies in Southeast Asia. QMS (ISO 13485 & GDPMD) Product registration Clinical investigations Local Authorized representation Distribution channels 9/23/13
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Introduction
Medical Device Authority (MDA) The Medical Device Authority (MDA) is a division in the Ministry of Health Malaysia (MOH) in charge of regulating medical device and its industry players in Malaysia. Objectives: • to protect the public health and safety and, • to ensure that new technology is made available for use for patients in a timely manner and at the same time facilitating trades and the medical device industry. How? through a comprehensive regulatory control and licensing system of: • medical device products • manufacturers, LAR, importers, and distributors. 9/23/13
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Introduction
Who and what will be affected? Establishments : manufacturer, distributor, importer,
authorized representative Medical Devices
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Introduction
Overview of the regulatory system Medical Device Act 2012 (act 737) Medical Device Regulations 2012
Schedules
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Contents
Introduction Definitions Arrangement of the Medical Devices Regulations 2012 Schedules
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Definitions
Establishment Act 737, section 2 “establishment” means: A) a person who is either a manufacturer, importer, or distributor who is responsible for placing any medical device in the market but does not include a retailer and B) an authorized representative* appointed by a manufacturer having a principal place of business outside Malaysia. * person domiciled or resident in Malaysia/a firm or company constituted under the laws of Malaysia 9/23/13
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Definitions
Medical device Act 737, section 2 “medical device” means: any instrument, apparatus, implement, machine, appliance, implant, in-vitro reagent or calibrator, software, material or other similar or related article intended by the manufacturer to be used, alone or in combination, for human beings for the purpose of: diagnosis, prevention, monitoring, treatment or alleviation of disease diagnosis, monitoring, treatment, alleviation of or compensation for an injury investigation, replacement or modification, or support of the anatomy or of a physiological process support or sustaining life control of conception disinfection of medical device, or providing information for medical or diagnostic purpose by means of in-vitro examination of specimens
derived from the human body, which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its intended function by such means; and
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Definitions
Medical device
b) any instrument, apparatus, implement, machine, appliance, implant, in-vitro reagent or calibrator, software, material or other similar or related article, to be used on the human body, which the Minister may, after taking into consideration issues of public safety, public health or public risk declare to be a medical device by order published in the Gazette.
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Introduction Definitions Arrangement of the Medical Devices Regulations 2012 Schedules
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Arrangement of regulations
Medical Device Regulations 2012
Part I: Preliminary
Part II: Conformity Assessment procedure
Part III: Registration of Medical Device
Part IV: Registration of Conformity Assessment Body
Part V: Establishment License
Part VI: Export permit
Part VII: Labelling Requirements
Part VIII: Appeal
Part IX: Register
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Arrangement of regulations
Part I: Preliminary
Regulations come into operation on 1st July 2013 Provides a definition for labelling, licensee, registration holder,
conformity assessment.
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Arrangement of regulations
Part II: Conformity Assessment Procedure
All medical devices shall be appropriately classified and grouped All medical devices shall be subjected to conformity assessment Depending on the class, the manufacturer shall appoint a CAB to
conduct the assessment
If the conformity assessment is successful, CAB will issue:
Report CoC
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Arrangement of regulations
Part III: Registration of Medical Device
Any application for registration of Medical Device shall be
made to MDA using the web-based online system The application shall be accompanied with: Application fee Supporting documents Any other information required by MDA Samples of medical device (if required)
If MDA is satisfied, the MD will be registered for a period of 5 years 9/23/13
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Arrangement of regulations
Part IV: Registration of CAB
Any person who wants to become a CAB shall comply with the
requirements specified in schedule 4th.
The CAB application shall be accompanied with: Application fee Supporting documents Any other information required by MDA
If MDA is satisfied, the CAB will be registered for a period of 3 years
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Arrangement of regulations
Part V: Establishment license
Any application for an establishment license shall be made to
MDA using MEDCAST.
The application shall be accompanied with:
Application fee Supporting documents Certificate and report of conformity assessment Any other information required by MDA
If MDA is satisfied, the establishment license will be issued for a period of 3 years 9/23/13
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Arrangement of regulations
Summary
Conformity 9/23/13
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Introduction Definitions Arrangement of the Medical Devices Regulations 2012 Schedules
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Structure
Schedules
First schedule: Rules of classification Second schedule: Rules of grouping Third schedule: Conformity Assessment procedure Fourth schedule: Requirements for the registration of CAB Fifth schedule: Table of fees Sixth schedule: Requirements for labelling 9/23/13
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Schedules
1st schedule: Rules of classification
This schedule provides some important definitions such as: Invasive medical device Central nervous system Active device intended for diagnosis Hazard Risk etc…
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Schedules
1st schedule: Rules of classification 4 classes: D C B A
The manufacturer shall be responsible for classifying its medical device 9/23/13
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Schedules
1st schedule: Rules of classification
Classification rules are provided in 2 appendices: Appendix 1 to classify Medical Devices excluding IVD Appendix 2 to classify IVD devices
If more than one rule is applicable, the higher classification shall apply.
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Schedules
2nd schedule: Rules of grouping
Medical Devices may be grouped into one of the following categories: single family system set in-vitro kit in-vitro cluster 9/23/13
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Schedules
2nd schedule: Rules of grouping
The basic rules of grouping consist of:
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one generic proprietary name
one manufacturer
one common intended purpose
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Schedules
3rd schedule : Conformity Assessment procedure Collection of evidence of conformity by the Manufacturer. If the manufacturer is not in Malaysia, it shall: authorize a LAr to act on its behalf provide all the evidence of conformity provide necessary support to the LAr for the purpose of the
assessment Depending on the class, a CAB shall be appointed to conduct the assessment. 9/23/13
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Schedules
3rd schedule : Conformity Assessment procedure Elements of the Conformity assessment: conformity assessment of the QMS conformity assessment of PMS conformity assessment of technical documentation DoC Device registration & Establishment listing
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Schedules
3rd schedule : Conformity Assessment procedure Upon completion of the conformity assessment procedure, an establishment may apply for:
establishment license
registration of medical device
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Schedules
3rd schedule : Conformity Assessment procedure (summary)
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Schedules
3rd schedule : Conformity Assessment procedure (Appendices) Appendix 1: Essential Principles of Safety and Performance of
Medical Device Appendix 2: Common Submission Dossier Template Appendix 3: Declaration of Conformity Appendix 4: Requirements on QMS
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Type of Establishment
QMS
Manufacturer
ISO 13485
Authorized representative
GDPMD
Importer
GDPMD
Distributor
GDPMD
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Schedules
4th schedule : Requirements for the registration of CAB's This schedule provides the requirements for a person who wish to be registered as a Conformity Assessment Body: requirements on organization requirements on resources and technical competency requirements on independence and impartiality requirements on Quality Management System
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Schedules
5th schedule : Table of fees (RM)
(CNY)
Manufacturer
250
481
Authorized representaEve
250
481
Distributor
250
481
Importer
250
481
Licensee fee
Manufacturer
4000
7700
Authorized representaEve
4000
7700
Distributor
2000
3850
Importer
2000
3850
Manufacturer
200
385
Authorized representaEve
200
385
Distributor
200
385
Importer
200
385
Manufacturer
2000
3850
Authorized representaEve
2000
3850
Distributor
1000
1925
Importer
1000
1925
Applica-on for renewal fee
Renewal fee
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Medical Device
Establishment license
Applica-on fee
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Applica-on fee Class A Class B Class C Class D Registra-on fee Class A Class B Class C Class D with medicinal product
(RM) 100 250 500 750
(CNY) 193 481 963 1444
0 1000 2000 3000 5000
0 1925 3850 5775 9625
Schedules
6th schedule : Requirements for labelling Provides requirements for: location format language contents IFU
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Summary
MedCast registration Access to Malaysian market MedCast registration
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www.andamanmed.com
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Sources
http://www.mdb.gov.my/mdb/ http://www.marketresearch.com/
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