Malaysia MDA Announces Second Phase Joint Evaluation Between Malaysia and China

By Yu Seen Ng, Amber Baade and Evangeline Loh

Background

Following an initial pilot regulatory reliance between Malaysia and China (signed agreement January 13, 2025) to facilitate medical device reviews between the Malaysia Medical Device Authority (MDA) and China's National Medical Products Administration (NMPA), respectively, MDA announced a second phase.

The second Joint Evaluation Pilot Programme operates between July 1- September 30, 2026, and is intended to be a “collaborative, simultaneous assessment” by both regulators. 

Eligibility criteria

The program is limited to manufacturers based in Malaysia or China (owning and operating the facility) with higher-risk medical devices or IVDs, no Class A or Class I, respectively. The devices must not have been registered before in either country and the manufacturer will submit to the authority where they are based. The MDA program will operate as a Full Conformity Assessment while NMPA will operate as a Special Channel Pilot.  

MDA process flow chart

In Appendix 1 of the announcement, the MDA shares a flowchart of the process. The manufacturer based in Malaysia submits premarket documentation to the MDA, and if the application meets the screening criteria, the Malaysia manufacturer can proceed with the next steps. The MDA identifies the Conformity Assessment Body (CAB) for full conformity assessment and simultaneously, the manufacturer submits an application to the NMPA. 

Details of the collaborative process are sparse, though the intent is for the MDA CAB and NMPA to review simultaneously and in consultation.  

Concluding remarks

Eligibility is limited, though this will be an interesting model.

Emergo experts will continue to monitor developments between the MDA and NMPA as well as this concept of regulators working to “enhance regulatory efficiency and market access through bilateral collaborative assessment, reducing duplicative evaluations to accelerate access to safe, effective, and high-quality medical devices in both markets while maintaining rigorous safety standards.”