Gain market access in Malaysia with MDB approval and certification

Malaysian Medical Devices Bureau (MDB) and conformity assessments

Malaysia-flagThe Malaysian Medical Device Act 2012 (Act 737) was fully enforced as of the 1 July 2013. 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 a regulation task of the regulatory authority may be delegated to reliable private bodies called a CAB. BSI has been approved as a CAB.