News
New law setting up a formal regulatory system for medical devices have been approved by the Malaysian government and will come into effect later this year, according to the Medical Device Control Division, Ministry of Health Malaysia.
The Medical Device Act 2012 or Act 737 specifies requirements for medical device product registration, establishment licensing and conformity assessment body (CAB) registration, replacing the current voluntary registration regime. Medical device manufacturers, importers as well as distributors will have to comply with the new regulation following its full implementation. The new law undergoes a transition period before it is fully enforced in two years' time (2014).
