Malaysia MDA Announces Second Reliance Pilot

By Yu Seen Ng and Evangeline Loh

Background on MDA and NMPA pilot

The Medical Device Authority (MDA) launched a two-month IVD Regulatory Reliance Program pilot with the China NMPA, scheduled from July 30 to Sept. 30. This gives IVDs from Malaysia access to the China Green Channel program and gives IVDs from China access to the MDA Verification Pathway. While there are conditions, IVDs that qualify benefit from reduced review times.

Pilot between MDA and Singapore HSA

At the ASEAN meeting (Aug. 22), the MDA and Health Sciences Authority (HSA) announced a regulatory reliance pilot between the two regulators (MDARIS#376| (17) MDA.6-2/1/4 JILID 5). This pilot starts on Sept. 1, 2025, and lasts for six months, ending on Feb. 28, 2026. Class B, C and D devices could benefit from expedited reviews.

Expedited review timeframes

Medical devices authorized by HSA may undergo the verification route with a Malaysia Conformity Assessment Body (CAB). CAB review through the verification route decreases the timeframe by 30 working days: CAB full conformity assessment review is 60 working days.

Medical devices registered with MDA could undergo an abridged HSA review in Singapore, which would reduce the review time by 30%.

Concluding remarks

This six-month pilot program offers medical device manufacturers a valuable opportunity to benefit from streamlined regulatory pathways. Building on the initial pilot between Malaysia’s MDA and China’s NMPA, this new collaboration with Singapore’s HSA explores how mutual reliance on regulatory reviews can help reduce duplication, shorten approval timelines and improve market access efficiency.

Reliance initiatives like these help improve access to IVD and medical devices across global markets, particularly in regions where navigating multiple regulatory systems can be challenging. Stay connected with Emergo by UL for the latest updates and expert insights on evolving strategies and international collaborations.