Market Access in Malaysia

Malaysian Medical Devices Bureau (MDB) and conformity assessments

The regulation of medical devices in Malaysia is carried out by the regulatory authority called Medical Devices Bureau (MDB), Ministry of Health.

Parts of the execution and surveillance of the Regulation by the regulatory authority may be delegated to reliable private bodies called a CAB. BSI has been approved as a CAB.

The Malaysian Medical Device Act 2012 (Act 737) was fully enforced on July 1, 2013.