Malaysia Continues to Improve its Medical Device Registration System

Last month, we reported on new consultation services for medical device registration applicants in Malaysia. This month on September 6, Dr. Muhammed Radzi, Malaysia’s Health Ministry Director General announced that Malaysia’s online application system will be upgraded to the MeDC@St 3.0 application system in stages during 2025. The upgrade is part of the Medical Device Authority’s (MDA) plans to increase digitalization.

The upgraded system will showcase new attributes like cloud infrastructure, mobile applications, AI, etc. The new system will help make its security system more robust and help accelerate device registration. Also, the MDA is preparing to integrate existing online services within one program also called i-MDA to enhance user experience. To develop the new MeDC@St 3.0 system, the MDA will partner with the Malaysian Administrative Modernization and Management Planning Unit which will provide advice to the MDA with respect to database management, systems development, etc.

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.