Regulatory Affairs Update: Malaysia

Malaysia: Encouragement to Submit Medical Device Re-Registration Applications One Year before the Certificate Expiration Date

Per the MDA/GL/08 entitled “Guidelines for Re-Registration of Registered Medical Devices,” applications for medical device re-registration are to be submitted online via the MeDC@St 2.0+ system one year before the certificate expiration date. The re-registration button will become available in the system one year prior, allowing establishments to submit their applications.

Simultaneously, as a form of improvement from the side of the Medical Device Authority (MDA), the expired certificates will be automatically deactivated in the current system. Failure to re-register before certificate expiration will necessitate submitting a new registration application. To ensure a seamless process, the MDA encourages all establishments to plan for re-registration and update change notifications before the certificate expires.

The MDA’s announcement can be accessed here.

If you have any queries about this draft guidance, please contact us at or click the button below.

Sign up for our regulatory roundup delivered once a month to your inbox

Scroll to Top

Contact Us