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If you have any queries about this draft guidance, please contact us at sales@andamanmed.com or click the button below.

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