By Stewart Eisenhart, Emergo Group
New laws setting up a formal regulatory system for medical devices have been approved by the Malaysian government, according to Med/Cert.
The two new laws will replace the current voluntary registration scheme for medical devices in Malaysia. Medical device manufacturers, importers as well as distributors will have to comply with the new requirements following their full implementation.
The first law, the Medical Device Act of 2012 (Act number 737), goes into effect “later this year,” but won’t be fully implemented until 2014. This law lays out requirements for device registration, establishment licensing and conformity assessment body registration.
The second law, the Medical Device Authority Act of 2012 (Act number 738), went into effect March 15 of this year, and provides details of the regulatory agency responsible for implementing the Medical Device Act in Malaysia.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.