September 17, 2018
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.
Initially, once the Medical Devices Act 2012 was first introduced and gazetted, MDA had provided a 4 year transition period, ending in June 30th 2016, for all medical devices to be imported, distributed and sold in Malaysia, to be mandatorily registered. This only applies to medical devices submitted for registration before June 30th, 2016. Medical devices submitted for registration after June 30, 2016 will only be allowed to be imported, exported or placed in the market after they are registered, regardless of the time taken for them to get approved.
It is to be noted that MDA was initially set to fully enforce the medical device registration requirements as prescribed under section 5 of Act 737 before importing, exporting or placing medical devices in the market from 1st January 2018 (see here).
However, following a high demand from the medical devices industry and unavailability of MDA to finish processing all the registration applications by 31st December 2017, in December 2017, MDA had agreed to provide an extension for period of moratorium on registration of medical devices submitted for application during the transition period, until June 30, 2018 (see here). . The extension of the moratorium period was to provide an opportunity for establishments to complete the documentation for the registration of medical devices that are still pending, as full enforcement of Medical Devices Act 2012 was to be enforced starting July 1st, 2018. It also reduces the disruption of procurement of medical devices in hospitals and health facilities.
Unfortunately, due to certain events, it has come to MDA’s notice that fully enforcing Medical Devices Act 2012 starting July 1st, 2018, may cause a disruption in medical devices supply for the purpose of diagnosis and patient treatment, as there are several medical device registration applications, which are still pending due to the recent resignation of MDA’s Chief Executive Officer. In regards to this, MDA has devised the following actions to control the disruption of new medical device supply in the market:
(i) Issue temporary approval letters for applications which have fulfilled all the necessary requirements set for the registration of a medical device and establishment licensing, while waiting for the official certificates to be issued. It is to be noted that, this temporary approval letter will automatically be void once the official registration certificate or establishment license is issued.
(ii) Display list of licensed establishments and registered medical devices on MDA’s official website for public view.
(iii) Any current medical device registration applications which do not comply with feedback requests (maklumbalas) from MDA for more than 6 months would be removed from MDA’s registrations and licensing application system; however, this will not restrict the establishment from making a new application once all the requirements are fulfilled.
For future information, please feel free to consult the translated version of MDA’s official announcement here.