Malaysia Eases Requirements for Low-Risk Devices

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 www.mdb.gov.my/medcast/login/. A registration certificate will be issued following an application’s approval  and will be valid for five years.