Malaysia market access

Malaysian Medical Devices Bureau (MDB) and conformity assessments

Malaysia market accessAs of the 1 July 2013, the Malaysian Medical Devices Act 2012 (Act 737) will be fully enforced in the country. 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.