Good news for manufacturers selling low-risk devices in Malaysia: You are exempt from premarket review requirements.
That’s according to the Malaysian Medical Device Authority, which says that all low-risk Class A medical devices are exempted from an assessment by the Conformity Assessment Body.
The order is effective as of April 18. Manufacturers may submit an application for Class A medical device registration at . A registration certificate will be issued following an application’s approval and will be valid for five years.