Representation for foreign manufacturers
Authorized Representative requirement
If a foreign company does not have a physical establishment in Malaysia, it is required to appoint a local license holder to be the Authorized Representative (AR). The AR shall be responsible for the device registration on behalf of the foreign manufacturers and take on the following duties:
- Act on foreign manufacturers’ behalf to conduct the conformity assessment, apply for review with CAB, and obtain MDA approval;
- Establish, maintain, and implement an appropriate QMS;
- Obtain establishment license;
- List its name, address, and contact on the label of represented devices;
- Maintain communication between CAB and MDA and the foreign manufacturer;
- Handle post-market activities and post-approval change management;
- Only one AR shall represent one product.
Latest Regulatory Developments
CE-marking accepted during EU-MDR transition
The certificates from recognized countries to support Malaysia registration shall be valid during the new registration and re-registration submission. However, due to the unpredictable timeline and issues with regards to the transition to the EU MDR, and to ensure continuous supply of the medical devices in the market, MDA has taken an approach to allow expired EC Certificate to be used for conformity assessment procedure by way of verification process with the registered CABs if the following conditions are met:
- The devices continue to comply with Directive 90/385/EEC and 93/42/EEC; and
- There are no significant changes in the design and intended purpose, and
- The devices do not present an unacceptable risk to the health or safety of patients, users, or other persons or other aspects of the protection of public health.
Labeling guidance
Update that the label should include
“Description and intended use” changed to “details necessary for a user to identify the device, the contents of the packaging, and, where it is not obvious for the user, the intended purpose of the device.”
Change notification guidance
.
Updated Version Includes EU Regulation Sections
Malaysia has categorized the types of changes, such as significant changes.
The baseline continues to be if you would inform the FDA and your Notified Body about a change, then this is also the time to inform the MDA.
Registration Validity
License validity
All manufacturers, authorized representatives (AR), importers, and distributors must apply for an establishment license. The validity of the establishment license is three years, and license renewal shall be applied one year prior to its expiry date. All manufacturers and AR (foreign manufacturers) must apply for medical device registration; the license is valid for five years.
Important links and guidance
Where to find more information?
Regulatory timelines and fees
Malaysia registration timeline
The turnaround times for receiving approval depend on the risk class, ranging from 30 working days for class A to 220 working days for class D.
*The mentioned fees are currently applicable and may be changed over the course of time.
