On July 30, 2025, the Medical Device Authority of Malaysia (MDA) launched the Malaysia–China Medical Device Regulatory Reliance Program (Pilot Phase I) with an end date of September 30, 2025. The program uses the Global Harmonization Working Party (GHWP) structure to form the first reciprocal regulatory reliance arrangement between two national authorities. The commencement of the program follows an MoU signed by Malaysia’s MDA and China’s National Medical Products Administration (NMPA) in 2023, and the program primarily focuses on in-vitro diagnostic (IVD) devices.
Under the new process, Chinese-made IVD devices are eligible for Malaysia’s Verification Pathway, and Malaysian-made IVD devices are eligible for China’s Green Channel. In order to qualify, Chinese-made products must be Class III products approved by the NMPA or Class II products approved by a provincial Medical Products Administration, and Malaysian-made products must be Class B, C, or D approved by the Malaysian MDA.
For registration in Malaysia, the Authorized Representative (AR) has to submit the required documentation to MDA for screening. If the MDA approves, it will appoint a Conformity Assessment Body (CAB) to perform a verification assessment. The process will continue with a routine online product registration. During the MDA screening process, innovative IVDs for rare diseases will have priority. It is important to note that there is a limitation of the pilot program to support only six applications across Malaysia. Submissions that do not meet the MDA screening requirements or are not prioritized in selection will need to go through the full CAB assessment and register via the regular pathway with the MDA.
The program will end on September 30, 2025. After the program concludes, the MDA will evaluate its effectiveness and make a decision on whether to further expand this program.
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.