MDA - Malaysia Medical Device Authority

The Medical Device Authority (MDA) is responsible for regulating medical device in Malaysia. Subordinated to the Ministry of Health, the MDA’s duties are set forth by the Medical Device Act 2012, act 738. The MDA has replaced the Medical Devices Bureau (MDB) established in September 2005.

The Medical Device Authority (MDA) is responsible for regulating medical device in Malaysia. Subordinated to the Ministry of Health, the MDA’s duties are set forth by the Medical Device Act 2012, act 738. The MDA has replaced the Medical Devices Bureau (MDB) established in September 2005.

Major Regulations

Some of the most important regulations for medical devices in Malaysia are:

A full list of MDA regulations can be found here.

Contact details:

Medical Device Associations in Malaysia: