Malaysia extension for manufacturer to submit registration supporting document and validity of acknowledgement letter by 30 June 2018

December 31, 2017

Refering to the announcement issued by the Medical Devices Authority (PBPP) regarding the full enforcement of medical device registration requirements under section 5, Act 737 issued on 25 July 2017, it is informed that PBPP at its meeting on 18 December 2017 has agreed to provide an extension for period of moratorium on registration of medical devices. After considering the high demand from medical devices industry, the extension of the moratorium is until June 30, 2018 and there is no further extension after the expiry of the moratorium. It only applies to establishments that have submitted applications on or before June 30, 2016. With this extension, a letter of acknowledgement receipt of application for medical device registration under Medical Device Act 2012 (Act 737) can still be used as a supporting document for the acquisition of medical devices . For medical devices made for registration after June 30, 2016 will only be allowed to be imported, exported or placed in the market after they are registered. The extension of the moratorium period provides an opportunity for the establishment of completing the documentation for the registration of medical devices that are still pending. It also reduces the disruption of procurement of medical devices in hospitals and health facilities.

 

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