In Malaysia, general medical and IVD devices are regulated by the Medical Device Authority (MDA) of the Ministry of Health. The regulatory framework is based on the Medical Device Act 2012 (Act 737) and Medical Device Regulations 2012 and closely follows GHTF guidelines. The legislation came into effect on July 1, 2013. Prior to that time, there was a voluntary registration system in place.
The MDA ultimately approves or rejects medical device applications.
A list of MDA regulations can be found here on our website.
- Website: http://www.mdb.gov.my/mdb/index.php