How to comply withMalaysia Medical

DeviceRegulations 2012?

Mourad Kholti5th March 2014

The 17th SE-Asian Healthcare Show,KLCC, Kuala Lumpur

Introduction

Based in Penang (Malaysia), Andaman Medical Sdn. Bhd. is a

consulting firm specializing in Medical Devices Regulatory Affairs

and Quality Management.

Expertise:• Product registrations & licensing in ASEAN region• Regulatory Strategies in ASEAN and Europe• Quality Management Systems: (ISO 13485, US FDA 21 CFR part 820, GDPMD)• Clinical Evaluation• Suppliers Auditing• Local Authorized Representation• Certification audit in partnership with a European Notified Body

Contents

DefinitionsLocal Authorized representativeArrangement of the MDR 2012Schedules of MDR 2012SummaryQ&A

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. 

Overview of the regulatory system

Medical Device

Act 2012 (act 737)

Medical Device

Regulations 2012

Schedules

Contents

DefinitionsArrangement of the MDR 2012SchedulesSummaryQ&ALocal Authorized representative

Definition “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

Definition “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.

Definition “Medical device”

The compression therapy knee brace is indicated for relief of weak or injured knees. With comfortable, breathable, soft, smell-free, materials, it is recommended for knee joint distortions and effusions, after surgical interventions, scars treatments, oedemas, sprains and contusions.

Medical device definition:…diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,

Is my product a Medical Device ?

Definition “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

Appointment of LAr

Distributor vs Independent Authorized Representative:

• Should my distributor focus on sales & marketing or on Regulatory Affairs? • Do I have to scrap all my labels, inserts and packaging, if I want to change

distributors ?• In case of incident due to transportation from the distributor to the end-user,

will my distributor defend his company or mine?• If my distributor is unable to answer MDA’s questions, does anyone in my

company have the skills to do so directly?• Will confidentiality be maintained when sharing a CSDT containing technical

information with my distributor?• Will my distributor stay up to date on regulatory changes in Malaysia and will

provide me with timely warning when changes affect my devices?

Contents

DefinitionsArrangement of the MDR 2012SchedulesSummaryQ&ALocal Authorized representative

Medical Device Regulations 2012

Part I: PreliminaryPart II: Conformity Assessment procedurePart III: Registration of Medical DevicePart IV: Registration of Conformity Assessment BodyPart V: Establishment LicensePart VI: Export permitPart VII: Labelling RequirementsPart VIII: AppealPart IX: Register

Part I: Preliminary

• Regulations come into operation on 1st July 2013

• Provides a definition for labelling, licensee, registration holder, conformity assessment.

Part II: Conformity Assessment procedure

All medical devices shall be appropriately classified and groupedAll medical devices shall be subjected to conformity assessmentDepending on the class, the manufacturer shall appoint a CAB to conduct the assessmentIf the conformity assessment is successful, CAB will issue:

Report Certificate of Conformity

Part III: Registration of Medical Device

Any application for registration of Medical Device shall be made to MDA using the web-based online systemThe 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 kept in the

register for a period of 5 years

Cancellation of registration

Part IV: Registration of a CAB

Any person who wants to become a CAB shall comply with the requirements specified in 4th schedule.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 of3 years

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 MDAIf MDA is satisfied, the establishment license will be issued for a period of 3 years

Suspension or revocation of establishment license

Part VII: Labelling requirements

Manufacturers shall ensure that the MD is appropriately labelled according to 6th schedule

Shall be legible, permanent, and prominent

No statement saying that the placement in the market is promoted or endorsed by MDA (fine RM10K and/or 3 months imprisonment)

Contents

DefinitionsArrangement of the MDR 2012SchedulesSummaryQ&ALocal Authorized representative

Schedules

First schedule: Rules of classification Second schedule: Rules of grouping Third schedule: Conformity Assessment procedureFourth schedule: Requirements for the registration of CABFifth schedule: Table of feesSixth schedule: Requirements for labelling

Medical Device Regulations

2012

Schedules

1st Schedule: Rules of classification

Some important definitions:• Invasive medical device• Central nervous system• Active device intended for diagnosis• Hazard• Risk• etc…

1st Schedule: Rules of classification

4 classes:

The manufacturer shall be responsible for classifying its medical device

A

BC

D

R I S K

1st Schedule: Rules of classification

Classification rules are provided in 2 appendices (tables):

• Appendix 1 to classify Medical Devices excluding IVD

• Appendix 2 to classify IVD devices

Example: all surgically invasive MD intended for short-term use are in class B (rule 7)

If more than one rule is applicable, the higher classification shall apply.

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

The basic rules of grouping consist of:• one generic proprietary name• one manufacturer• one common intended purpose

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 behalfprovide all the evidence of conformityprovide necessary support to the LAr for the purpose of the assessment

Depending on the class, a CAB shall be appointed to conduct the assessment.

3rd Schedule: Conformity Assessment procedure

Elements of the Conformity assessment:conformity assessment of the QMSconformity assessment of PMSconformity assessment of Technical documentation (CSDT)DoCOnce assessment completed

3rd Schedule: Conformity Assessment procedure (Summary)

Source: Medical Device Authority

3rd Schedule: Conformity Assessment procedure (Appendices)

Appendix 1: Essential Principles of Safety and Performance of Medical Device (checklist)Appendix 2: Common Submission Dossier TemplateAppendix 3: Declaration of ConformityAppendix 4: Requirements on QMS

Type of Establishment QMS

Manufacturer ISO 13485

Authorized representative GDPMD

Importer GDPMD

Distributor GDPMD

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 organizationrequirements on resources and technical competencyrequirements on independence and impartialityrequirements on Quality Management System

5th Schedule: Table of fees

Establishmen

t licen

se

Application fee(RM

) (EUR)Manufacturer 250 55Authorized representative 250 55Distributor 250 55Importer 250 55Licensee fee  Manufacturer 4000 880Authorized representative 4000 880Distributor 2000 440Importer 2000 440Application for renewal feeManufacturer 200 44Authorized representative 200 44Distributor 200 44Importer 200 44Renewal feeManufacturer 2000 440Authorized representative 2000 440Distributor 1000 220

Importer 1000 220

Medical Device

Application fee (RM) (EUR)Class A 100 22Class B 250 55Class C 500 110Class D 750 165Registration feeClass A 0 0Class B 1000 220Class C 2000 440Class D 3000 660

with medicinal product 5000 1100

6th Schedule: Requirements for labellingProvides requirements for:• Location: on the device itself• Format: if symbols are used, provide

explanation• Language: Bahasa Melayu for home-

used devices (also for others if required by MDA)

• Contents: manufacturer AND LAr names, lot nbr, serial nbr, expiry date…

• IFU: precautions and warnings, etc…

How do you feel now ?

Let’s summarize…

Preparation

Classify your Medical Device

Group your devices

Identify your CAB

Establishment licenses(before June 30th 2014)

Manufacturer (ISO13485)

Authorized rep (GDPMD)

Importer (GDPMD)

Distributor (GDPMD)

Conformity assessment(before June 30th 2015)

Manufacturer QMSManufacturer PMSSummary Technical

DocumentationDeclaration of

Conformity

MedCast registration

MedCast registration

MDA approval

www.andamanmed.cominfo@andamanmed.com

Sources

http://www.mdb.gov.my/mdb/

Q&A