Malaysia MDA Announces Agreement Between Malaysia and China

By Yu Seen Ng, Janet Zhang, and Evangeline Loh

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.

Explanation for this joint agreement

It was explained that most of the products registered with NMPA brought into Malaysia from China are Class C and Class D. And most of the products manufactured in Malaysia are Class B (and Class A). Dr. Paramasua mentioned that a Class B product permitted by MDA could require as long as two years before a complete review by NMPA for access to the China market. Hence, the program is proposed to reduce the review times.

Concluding remarks

Emergo will continue to monitor developments related to this Joint Assessment. However, our experience is consistent with this as well. In addition, the MDA announced that there are current discussions with the regulator in South Korea, MFDS.

The prospects for 2025 and regulatory reliance are exciting, and these initiatives from the MDA certainly add to that.