January 27, 2026
By Yu Seen Ng and Evangeline Loh
Background
Similar to last year, Dr. Muralitharan Paramasua, Chief Executive, of the regulator in Malaysia, Medical Device Authority (MDA), hosted the 2026 key note address (January 27).
The first part described 2025 achievements and the second, expectations for the new year. The numbers included: 14,446 medical devices registered, 3,707 Establishment Licenses approved, 95% Class A medical devices registered in 14-21 days, 11 Conformity Assessment Bodies (CABs) approved, three international MOU (Singapore HSA, Thai FDA), and two international reliance.
2025 was a year of regulatory reliance
The Regulatory Reliance Pilot with the China NMPA concluded. This was an IVD pilot with NMPA which permit IVDs from Malaysia to access the China Green Channel program and IVDs from China to use the CAB MDA Verification Pathway. The second pilot with the HSA would allow Class B, C, and D devices expedited reviews. Again, medical devices authorized by HSA could undergo CAB MDA Verification Pathway, and those registered with the MDA an abridged review with the HSA. The last Regulatory Reliance program with the Thai FDA would reduce review times for Class B, C, and D devices authorized by the MDA or Thai FDA.
Expectations for 2026
Similar to 2025, e-labeling and UDI, and Medcast 3.0, were included on the 2026 list. In addition, conducting reliance activities with the following countries was identified: Egypt, Indonesia, Oman, Brazil, India, UAE and Russia. And those continuing to strengthen the reliance activities from 2025 were: China, Singapore, and Thailand. Last, a proposal for an ASEAN framework for a single submission was accepted by four countries: Malaysia, Singapore, Thailand, and Indonesia.
Concluding remarks
Emergo by UL experts continue to monitor global regulatory developments. It is particularly exciting to note developments with regulatory reliance.
In addition, the MDA, like other regulators, has shared their aspirations for 2026: US FDA guidance, Brazil and Australia.
We look forward to see how the global regulatory developments in 2026 develop and how these impact global regulatory strategy.
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