Malaysia MDA Furthers Regulatory Reliance with China NMPA

By Yu Seen Ng and Evangeline Loh

During the 2025 Malaysia keynote address, the Medical Device Authority (MDA) announced initiatives related to joint assessments between the MDA and China’s National Medical Products Administration (NMPA). In vitro diagnostic (IVD) devices may now benefit from the regulatory reliance between the two regulators.

MDA press release

The MDA signaled its efforts with a press release (July 16) titled “Malaysia leads the world in medical device regulatory reliance.” This “represents a strategic breakthrough in accelerating access to safe and innovative medical technologies.”

The third paragraph provides a synopsis of the program. IVDs from Malaysia would have access to the China Green Channel program and IVDs from China would be subject to the MDA Verification Pathway.

Details of the IVD regulatory reliance program

Further details about the IVD collaboration were shared in an email (July 22). IVDs made in Malaysia would be eligible for the Green Channel program, reducing the approval timeline to 60 working days from two years. IVDs made in China would benefit from the shortened review time of 30 days, through the Verification Pathway, compared to 90 days for the full conformity assessment review.  

In both cases, the IVD needs to be manufactured in the home country, the manufacturer in the home country needs to own and operate the manufacturing facility in the country and the IVD must be registered in the home country.

Better IVD access globally

The program further advances regulatory reliance and will benefit manufacturers of IVDs in Malaysia and China, as well as the patients and healthcare professionals in Malaysia and China.

We at Emergo by UL expect the regulatory developments and collaboration between the two countries to continue, and we will continue to report on global regulatory developments. Regulatory reliance is an important initiative to advance medical device access globally.