Malaysia Regulatory Approval Process for Medical Devices

Download the Chart on the Medical Device Approval Process in MalaysiaThe chart shown illustrates Malaysia's approval process and is available for download in PDF format. However, if you would like to explain the steps to someone else in an email, you can cut and paste the text below or send them a link to this page.

Malaysia's medical device approval process explained

Foreign manufacturers entering the Malaysian market will be able to leverage their existing approvals in recognized reference markets (Australia, Canada, European Union countries, Japan, and the United States).

Step 1
Determine the classification of your 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
If you have no local presence in Malaysia, appoint a Malaysia Authorized Representative to manage your medical device registration.

Step 3
Engage an accredited Conformity Assessment Body (CAB) to perform an abridged technical review of your documentation. Prepare documentation for the CAB, which may include ISO certificate, labeling, CE Certificate, etc., as appropriate for your device.

Step 4
CAB reviews the documentation and issues certification upon favorable 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
Your Malaysia Authorized Representative submits your application electronically via the MDA Medical Device Centralized Online System (MeDC@St). Pay fee. All documents can be submitted in English. Devices for home use must have IFU and labeling in Bahasa Malay.

Step 8
MDA verifies classification. After evaluating your application they will either approve or reject it.

Step 9
Upon approval, your product is added to the MDA's list of registered medical devices. Registrations must be renewed every five years.

Step 10
Your Malaysia Authorized Representative authorizes an importer and/or distributor. You may now begin marketing your device in Malaysia.

This is a simplified overview of the process. The Medical Device Authority of Malaysia may choose to audit your submission and request more documents, which will add time to your approval.

** Per Circular 3 of 2014, the MDA has modified Appendix 1 to state that all Class A devices which are non-active, non-sterile, and have no measuring function are exempt from registration requirement. The MDA must be notified before an exempt device may be imported.

© 2015 Emergo Group
Chart updated: 16/04/2015