China and Malaysia launch reciprocal medical device reliance pilot programme
Written by: Manuel Mateos CEO and Regulatory Affairs Director, CMC Medical Devices & Drugs S.L.
On 30 July 2025, the regulatory authorities in China and Malaysia launched a two-month pilot programme to grant companies accelerated access to market for certain medical devices. The pilot phase will end on 30 September 2025.
A reciprocal agreement for faster access
The pilot programme has two main components:
- Chinese manufacturers can access Malaysia’s verification pathway.
- Malaysian manufacturers can benefit from China’s green channel.
This initiative follows the memorandum of understanding signed in 2023 between Malaysia’s Medical Device Authority (MDA) and China’s National Medical Products Administration (NMPA). Both agencies agreed to mutually recognise regulatory decisions for in vitro diagnostic (IVD) medical devices under a reliance pathway.
Malaysia’s verification pathway
Malaysia’s verification pathway reduces review times to 30 working days. It was designed to accelerate access to devices already approved in overseas markets such as the European Union, Japan and the United States.
To be eligible, Chinese manufacturers must:
- Be based in China.
- Own and operate their own facilities in China.
- Submit either Class II devices approved by a provincial medical products administration or Class III devices approved by NMPA.
Third-party brand owners, such as rebranders, relabelers and assemblers, are excluded. MDA has also announced that it will prioritise applications involving rare diseases and innovative devices.
China’s green channel
China’s green channel was created by NMPA to shorten review times for certain medical devices covered by Chinese patents to 60 working days.
Malaysian manufacturers can apply if they:
- Are based in Malaysia.
- Own and operate their own facilities in Malaysia.
- Submit Class B, C or D devices approved by MDA.
Third-party brand owners are not eligible. NMPA has not specified its priority areas at this stage.
Application limits and next steps
Both MDA and NMPA will accept up to six applications during this pilot phase.
Although the programme is limited in scope, it marks a significant milestone in Asia-Pacific regulatory cooperation. If successful, it could pave the way for broader reliance models and faster patient access to innovative medical technologies.
Key takeaway: The pilot programme runs from 30 July to 30 September 2025. Eligible manufacturers now have the opportunity to benefit from accelerated access to two key Asia-Pacific markets.
For further details, you can consult the official MDA announcement.
