Mandatory Registration of Establishments The Medical Device Act 2012 requires all medical device es

Mandatory Registration of Establishments
The Medical Device Act 2012 requires all medical device establishments to register and obtain permits and licenses from Malaysia’s Ministry of Health. Establishments include: manufacturers, importers, exporters, distributors, local authorized representatives, and conformity assessment bodies of medical device products.

Registered medical device establishments will be required to have good design and manufacturing standards, conform to safety and quality assessment standards, and have proper procedures in the event of voluntary/mandatory recall.