July 13, 2018
MDA has released a Circular Letter at the end of May 2018 as a reminder notice on the complete enforcement of requirements for registration of medical device under Section 5 of Medical Device Act 2012 (Act 737), whereby no medical device can be allowed to be imported, exported or marketed in Malaysia unless it has been registered with MDA, according to this Act.
Starting from July 1st 2018, only registered medical devices which have already obtained certificates from MDA are allowed in the procurement of medical devices by any healthcare institute in Malaysia. In light of that, Letter of Acknowledgement Receipt of Application for Medical Device Registration under Medical Device Act 2012 (Act 737) is no longer valid to be used as a supporting document in the procurement of medical devices in any healthcare institutions.
It is also to be noted here that sub-section 5(1) of Act 737 denotes that unregistered medical devices cannot be imported, exported or placed in the market in Malaysia, while sub-section 5(2) of the same Act underlines that any party convicted guilty according to the sub-section 5(1) of this Act, can be fined up to two hundred thousand Ringgit or imprisoned for a period not longer than three years or both.