In the past, Malaysia’s medical device authority (MDA) issued only paper physical Medical Device Registration Certificates. Starting May 2, the MDA started issuing registration certificates electronically. During the transition period from May 2 to December 31 this year, the MDA will issue both paper and electronic certificates, which can be downloaded from the MeDC@St2.0+ system. Starting on January 1, 2024, Product Registration Certificates in Malaysia will only be available electronically, and the MDA will not issue physical certificates.
Similar to other ASEAN countries, Malaysia has four classifications for medical devices (classes A, B, C, and D). The first step to register a device in Malaysia includes getting a Certificate of Conformity from a Conformity Assessment Body (CAB). Afterward, medical device applications need to be uploaded onto Malaysia’s MEDCAST network.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.