MALAYSIA: MDA ANNOUNCED MANDATORY PROBLEM REPORTING REQUIREMENTS UNDER ACT 737 AND RULE 2019 − OCTOBER/NOVEMBER 2023

• 2023-10-20 06:51:30

The Medical Device Authority (MDA) announced on 19th September that any event involving registered medical devices that occurs outside of the country is not required to be reported to MDA if the incident has been notified to the regulatory agency in the country where the incident happened and corrective action or precautions have been taken by the manufacturer or establishment.

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MALAYSIA: MDA revised guideline on how to apply for medical device registration under medical device act 2012 (Act 737) – May, 2019

• 2020-05-06 05:10:35

In a recently issued revised guideline on How to Apply for Medical Device Registration Under Medical Device Act 2012 (Act 737), MDA specified that it can drop an ongoing application from MeDC@St system if it exceeds a 90 days stop-clock-time and any new applications which do not conform to requirements specified will be rejected, non-refundable.

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MALAYSIA: Announcement Regarding Registration Application of Medical Devices and Licensed Establishment under Medical Devices Act 2012 (Act 737) Which Are Still Pending, Following End of Transition Period - September 2018

• 2020-02-12 15:06:56

MDA has issued a new announcement regarding registration application of medical devices and licensed establishment under Medical Devices Act 2012 (Act 737) which are still pending, following the end of transition period.

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