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How to comply with
Malaysia Medical Device
Regulations 2012?
Mourad Kholti
5th 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
Definitions
Local Authorized representative
Arrangement of the MDR 2012
Schedules of MDR 2012
Summary
Q&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
Definitions
Arrangement of the MDR 2012
Schedules
Summary
Q&A
Local 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
Definitions
Arrangement of the MDR 2012
Schedules
Summary
Q&A
Local Authorized representative
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
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
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
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 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 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 of
3 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 MDA
If 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
Definitions
Arrangement of the MDR 2012
Schedules
Summary
Q&A
Local Authorized representative
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
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
B
C
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 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.
3rd Schedule: Conformity Assessment procedure
Elements of the Conformity assessment:
conformity assessment of the QMS
conformity assessment of PMS
conformity assessment of Technical documentation (CSDT)
DoC
Once 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 Template
Appendix 3: Declaration of Conformity
Appendix 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 organization
requirements on resources and technical competency
requirements on independence and impartiality
requirements on Quality Management System
5th Schedule: Table of fees
E
stab
lish
men
t lic
ense
Application fee (RM) (EUR)
Manufacturer 250 55
Authorized representative 250 55
Distributor 250 55
Importer 250 55
Licensee fee
Manufacturer 4000 880
Authorized representative 4000 880
Distributor 2000 440
Importer 2000 440
Application for renewal fee
Manufacturer 200 44
Authorized representative 200 44
Distributor 200 44
Importer 200 44
Renewal fee
Manufacturer 2000 440
Authorized representative 2000 440
Distributor 1000 220
Importer 1000 220
Med
ical
Devi
ce Application fee (RM) (EUR)
Class A 100 22
Class B 250 55
Class C 500 110
Class D 750 165
Registration fee
Class A 0 0
Class B 1000 220
Class C 2000 440
Class D 3000 660
with medicinal product 5000 1100
6th Schedule: Requirements for labelling
Provides 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 QMS
Manufacturer PMS
Summary Technical Documentation
Declaration of Conformity
MedCast registration
MedCast registration
MDA approval
Q&A
