Background
The Chief Executive, Dr. Muralitharan Paramasua, of the regulator in Malaysia, the Medical Device Authority (MDA), hosted the 2025 keynote address (January 14).
Many programs were presented: e-labeling, UDI, import permit, guidance documents, Medcast 3.0, additional recognized ASEAN countries, and Class A fees. This update focuses on one of the global harmonization/regulatory reliance initiatives.
Joint agreement between China and Malaysia signed
Dr. Paramasua announced that China and Malaysia had signed an agreement (January 13) to facilitate medical device reviews between the National Products Administration (NMPA) and Medical Device Authority (MDA), respectively.
While the evaluation framework is in development, the proposed assessment would allow Class C and Class D products authorized by NMPA to be registered in Malaysia in 1-2 months. Similarly, Class B products authorized by MDA would be registered in China in 1-2 months.
Malaysia MDA Announces Agreement Between Malaysia and China
Malaysia MDA Announces Agreement Between Malaysia and China
This agreement paves the way for facilitating the access of manufacturers in Malaysia to China and, conversely, manufacturers in China to Malaysia.
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