REGULATORY

REQUIREMENT FOR
MALAYSIA
Registration and labelling requirements for
Tristel DUO ORL

Abul Ehsan
29/03/2017
1.0 Introduction
Malaysia is a member of the Association of Southeast Asian Nations (ASEAN), a trade bloc that
promotes mutual economic development in Southeast Asia. Under the ASEAN roadmap for
healthcare integration, medical device regulations and standards across all ten member countries are
harmonized in a comprehensive directive: the ASEAN Medical Devices Directive (AMDD). Member
countries will transpose the AMDD into their national legislation. AMDD requirements are basically
the same as the requirements from the Global Harmonization Task Force (GHTF), the predecessor
organization to the International Medical Device Regulators Forum (IMDRF), in regards to medical
device definition, risk classification system, and Essential Principles of Safety and Performance.

In Malaysia, general medical and IVD devices are regulated by the Medical Device Authority
(MDA) of the Ministry of Health. The regulatory framework is based on the Medical Device Act
2012 (Act 737) and Medical Device Regulations 2012, and closely follows GHTF guidelines.

2.0 Classification
Medical disinfectants are classified as medical devices. Medical devices in Malaysia are classified
according to rules listed in Medical Device Regulations 2012, Appendix 1 of Schedule 1. Medical
devices are classified as Class A (low risk), Class B (low to moderate risk), Class C (moderate to high
risk), and Class D (highest risk). MDA classification rules are adopted from the GHTF
recommendations, so they are similar to those in the European Medical Device Directive (MDD)
93/42/EEC.

Tristel DUO ORL will be classified as class C medical device according to rule 15 of First Schedule
on Rules of Classification of Medical Device.
3.0 Regulatory Requirements
Authorized Representative requirements for foreign manufacturers:

Foreign manufacturers (outside Malaysia) must appoint an in-country Authorized Representative

(AR) to manage device registration and to authorize an importer and distributor to import and
supply devices post approval. Only one AR can be appointed per device. However, a foreign
manufacturer with multiple devices is allowed to appoint more than one AR. As in many other
countries, the Authorized Representative serves as the regulatory liaison with the Ministry
of Health.

Registration requirement:
Registration in Malaysia begins with a conformity assessment by an accredited Conformity
Assessment Body (CAB) followed by the product registration with the MDA.
Step 1
Determine the classification of the medical device according to Appendix I of Medical Device
Regulations 2012 as published by the Medical Device Authority (MDA) of Malaysia. The MDA
classification rules are similar to those in the European Medical Devices Directive (MDD)
93/42/EEC.

A sub-group of Class A devices (Class A Exempt**) have an abbreviated path to market, requiring
only appointing a Malaysia Authorized Representative and a notification to the MDA before
importing.
Step 2

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If there are no local presence in Malaysia, appoint a Malaysia Authorized Representative to manage
the medical device registration.
Step 3
Engage an accredited Conformity Assessment Body (CAB) to perform an abridged technical review
of the documentation. If a device has been approved in one of the recognized reference markets (US,
Europe, Australia, Japan, and/or Canada), the manufacturer can leverage this approval and complete a
simplified CAB review. This simplified process provides CAB review based on a verification of
evidence based compliance in one of the reference markets. However, manufacturers leveraging
approval from one of the reference countries should consider that their Malaysia CAB cannot be the
same entity as their EU Notified Body (NB).
Prepare documentation for the CAB, which may include ISO certificate, labelling, CE Certificate,
etc., as appropriate for the device.
Step 4
CAB reviews the documentation and issues certification upon favourable review.
Step 5
Prepare a Technical File using ASEAN Common Submission Dossier Template (CSDT) format.
Summary data can be submitted for pre-clinical and clinical data.
Step 6
Prepare submission application according to requirements found in Medical Device Regulations 2012
and applicable guidance documents.
Step 7
The Malaysian Authorized Representative submits the application electronically via the MDA
Medical Device Centralized Online System (MeDC@St). Pay fee. All documents can be submitted in
English.
Step 8
MDA verifies classification. After evaluating the application, they will either approve or reject it.
Step 9
Upon approval, the product is added to the MDA's list of registered medical devices. Registrations
must be renewed every five years.
Language and labelling requirements:
In general, an EU label can be used (with mandatory English translation) with the addition of the
Malaysian medical device registration number, as well as the contact information of the Malaysia
Authorized Representative. Labelling in English for professional-use only devices is sufficient.
Labelling may be provided to the user in various media and by several means such as printed
documents, through a display screen incorporated into the device, the manufacturer’s website and
magnetic or optical media. Whatever the media or the means, information should be targeted to the
anticipated user population.
Labelling activities to meet the Medical Device Act and regulations, may be conducted post
importation or manufacturing, but prior to placing in the market. Contents of labelling shall be as per
submitted to the authority during medical device registration. There shall be no over labelling on the
lot/batch or serial number, date of manufacturing and date of expiry.

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4.0 Time Frame and Cost Estimation
Registration fee and validity of Certificate of product registration:

Class Turn-around Application Fee Registration Fee Certificate

time (RM) (RM) Validity
Class A 1-2 months 100 N/A 5 Years
Class B 3-4 months 250 1000 5 Years
Class C 6-7 months 500 2000 5 Years
Class D 7-8 months 750 3000 5 Years
Product Family Depending on 750 5000 5 Years
class

Application and registration fees are payable to the MDA. Application fees are due immediately upon
submission of the application dossier. A registration fee is due once the medical device registration
application is approved by the MDA. No registration fee is charged for a Class A medical device.
There is additional cost for Conformity Assessment Body (CABs) review. Cab certificates are valid
for 5 years.
No additional validation will be required.
5.0 Strategic pathways
We currently have Schmidt BioMedTech Sdn. Bhd as our authorised representative in Malaysia.
Historically, they have managed all our medical device registration in Malaysia and bared all cost. We
can prepare and submit the required documents to them and they will register the product.
6.0 Conclusion
Tristel DOU ORL is a class C medical device in Malaysia, which requires registration. Estimated total
time required for dossier preparation, submission and approval is approximately 12 months. Our
multilingual EU (Only English is sufficient) label and user guide will be sufficient in Malaysia with
addition of Malaysian registration number and distributor details, which can be added on locally after
import as a separate add on label or internally during packing. No consultant required. No additional
cost (presuming Schmidt bares the cost of registration).
7.0 References
Government Act/ Law/ Regulation/ Rules/ Guideline:
I. Medical Device Act 2012 (Act 737)
II. Medical Device Regulations 2012
III. MDA/GL/MD-01, June 2014, Second Edition
IV. MDA/GD/0026, November 2015, Requirements for labelling of medical devices
V. MDA_GD01 Definition of Medical Device-First Edition_20 Mac2014
VI. MDA_GD04-classrules_ First Edition_20 Mac2014
Website:
VII. http://www.mdb.gov.my/mdb/index.php?
option=com_content&task=view&id=38&Itemid=95
VIII. https://www.emergogroup.com/resources/malaysia-process-chart

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