The Medical Device Regulations 2012, the subsidiary legislations under the Medical Device Act 2012 (Act 737), has been approved by the Malaysian Minister of Health and has been published in the Gazette on 31st December 2012. The Regulations will come into operation simultaneously with Act 737 on 1st July 2013. And as specified in Act 737 a transition period of two years for medical device registration and one year for establishment licensing will be given to the industry before it is fully enforced.

1. How to comply with
Malaysia Medical Device
Regulations 2012?
Mourad Kholti
5th March 2014
The 17th SE-Asian Healthcare Show,
KLCC, Kuala Lumpur

2. 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

3. Contents
Definitions
Local Authorized representative
Arrangement of the MDR 2012
Schedules of MDR 2012
Summary
Q&A

4. 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.

5. Overview of the regulatory system
Medical
Device Act
2012 (act
737)
Medical
Device
Regulations
2012
Schedules

6. Contents
Definitions
Arrangement of the MDR 2012
Schedules
Summary
Q&A
Local Authorized representative

7. 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,

8. 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.

9. Definition “Medical device”
Is my product a 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,

10. 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

11. 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?

12. Contents
Definitions
Arrangement of the MDR 2012
Schedules
Summary
Q&A
Local Authorized representative

13. 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

14. Part I: Preliminary
• Regulations come into operation on 1st
July 2013
• Provides a definition for labelling,
licensee, registration holder, conformity
assessment .

15. 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

16. 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

17. 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

18. 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

19. 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)

20. Contents
Definitions
Arrangement of the MDR 2012
Schedules
Summary
Q&A
Local Authorized representative

21. Schedules
Medical Device
Regulations 2012
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

22. 1st Schedule: Rules of classification
Some important definitions:
• Invasive medical device
• Central nervous system
• Active device intended for diagnosis
• Hazard
• Risk
• etc…

23. 1st Schedule: Rules of classification
4 classes:
A
B
C
D
R I S K
The manufacturer shall be responsible for
classifying its medical device

24. 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.

25. 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

26. 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.

27. 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

28. 3rd Schedule: Conformity Assessment
procedure (Summary)
Source: Medical Device Authority

29. 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

30. 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

31. 5th Schedule: Table of fees
Establishment license
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
Medical Device
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

32. 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…

33. How do you feel now ?

34. 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

35. www.andamanmed.com
info@andamanmed.com

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

37. Q&A