To register devices in Malaysia, you must make a dossier submission according to the required items in the Medical Device Act of 2012, and the specific instructions outlined on the Malaysia Medical Device Authority (MDA) website. Starting May 1, the MDA changed the amount of time that Applicants have to finalize an incomplete dossier – if the initial dossier was returned after the first review. In the past, Applicants had 90 days to respond to the MDA if their initial submission was not deemed complete. Now, the MDA has reduced the time to respond with complete submission to only 30 days. This new deadline is applicable for new applications, re-registration applications, and change notices.
If the follow-up submission is not fully completed within 30 days after the initial submission, the MDA will delete the device application from their system and return it to the Applicant. Even if this occurs, the Applicant can make a new submission on the same product, but they will be required to pay the Government fees again and the registration time will obviously be longer.