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. Foreign manufacturers (outside Malaysia) must appoint an in-country Authorized Representative (AR) to manage device registration and to authorize an importer and distributor to import and supply devices post approval.
In this white paper:
- Authorized Representative requirements
- Medical Device Assessment and Classificiation
- Regulatory Pathways
- Registration Requirements
- and more.
About the Author:
Jetty van der Woude is a Global Regulatory Specialist in Emergo's USA Headquarters.