Malaysia Regulatory Approval Process for Medical Devices

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.

Step 2
If you have no local presence in Malaysia, appoint a Malaysia Authorized Representative to manage your medical device registration with the MDA. Manufactures may only appoint one Authorized Representative per device family.

Step 3
For classes B, C, and D, engage an accredited Conformity Assessment Body (CAB) to perform an abridged technical review of your documentation. Prepare documentation for the CAB using ASEAN Common Submission Dossier Template (CSDT) format, which may include ISO certificate, labeling, CE Certificate, etc., as appropriate for your device.

Step 4
CAB reviews the documentation and issues certificate.

Step 5
For all devices, prepare final submission package, composed of the CSDT, the CAB certificate, and MDA application forms.

Step 6
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 7
MDA verifies classification. After evaluating your application, they will request additional information or documents if any deficiencies are noted; if these cannot be fulfilled, the application is rejected.

Step 8
Upon approval, a Certificate is issued and a Registration Number is assigned. Registrations and CAB Certificates must be renewed every five years.

Step 9
Your Malaysia Authorized Representative must issue authorization letters allowing your importer and/or distributor to perform those functions for your device.

This is a simplified overview of the process.

* This chart demonstrates the route to compliance in Malaysia for devices that have already obtained approval in a reference market. Recognized reference markets include: Australia, Canada, European Union countries, Japan, and the United States. This is not a requirement and an approval process does exist for imported devices with no reference market approval; however, the process in Malaysia will be eased by already having such approvals.

Chart updated: 06/24/2019