Malaysia: The Removal of Incomplete Medical Device Registration and Change Notification Application

Medical Device Authority (MDA) of Malaysia released a statement on 23 March 2023 regarding the abortion of new or renewal medical device registration applications and medical device amendments.

Starting from 1 April 2023, MDA will abort all incomplete medical device registration for both new or renewal applications and also incomplete medical device amendment within 30 working days. All establishments were given one month transitional period which is until 1 May 2023 for the adaption before the abortion rules are implemented.

Next, it is advisable to submit medical device registration either for a new or renewal application completely attached the information details and supporting documents as stated in Medical Devices Act 2012/737, Medical Devices Regulations 2012 and MDA circulars. More information regarding the registration can be viewed on the official MDA website. Any incomplete submission will be returned to the establishment.

All the application submissions will be aborted if the establishment fails to submit feedback within 30 working days or if the establishment returns the submission with incomplete information or supporting documents. This will not affect any establishment to apply new applications. However, all application fees that had been made will not be refunded.

Source: MDA

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