January 15, 2018
Malaysian lawmakers take medical device related issues pretty seriously, starting with the introduction of the Medical Device Act 2012 (Act 737) and Medical Device Regulations 2012. A faulty pacemaker or even a leaking catheter are the last things patients need to worry about as they may pose various levels of threat to their lives. In regards to this, the Medical Device Authority (MDA), a body under the Health Ministry tasked with supervising the country’s medical devices industry, had made it compulsory for all the manufacturers of medical devices marketed in Malaysia to register their devices with the MDA and keep record of their commercial activities.
The MDA had initially set October 31, 2017 as a deadline for manufacturers to comply with the registration requirement and the full enforcement of the Medical Device Act 2012 was supposed to be taking effect on January 1, 2018. But just a week before the year end, the Health Ministry has extended the above-mentioned moratorium by six months to allow those who have submitted medical devices’ registration applications by June 30, 2016 the extra time to complete their documentations to support their applications, after considering the high demand from medical devices industry. This means that the applicants will technically have until June 30, 2018 to complete their pending documentations and submit them to the MDA. There will be no further extension after the expiry of the moratorium. With this extension, a Letter of Acknowledgment 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, until June 30, 2018. The decision to allow the extension was reached by the MDA during its meeting on December 18, 2017. The ministry’s rationale is that it does not want to cause any disruptions of medical device supplies to hospitals and any other medical institutions.
So, any medical device manufacturer who had been conducting commercial activities in Malaysia prior to registering these devices during the transition period set by the MDA, by June 30, 2016, must strive to get their product registration done by June 30, 2018 if they intend to continue these commercial activities after that. If they fail to obtain the registration after June 30, 2018, they must proceed to immediately retract their products from the market in order to comply with the implementation of Medical Device Act 2012 and Medical Device Regulations 2012, whereby it is illegal to conduct any commercial activities (importation, distribution and marketing) with unregistered medical devices. In pursuant to subsection 5 (1) of Act 737, medical devices not registered under this Act shall not be imported, exported or marketed while subsection 5 (2) of the same Act provides that any person convicted of an offense under subsection 5 (1) of this Act, will be charged with a fine not exceeding two hundred thousand ringgit (fifty thousand USD) or imprisonment for a term not exceeding three years or both.