Malaysia MDA and Singapore HSA Regulatory Pilot Successful, Ongoing Implementation

By Sreenu Sattu and Evangeline Loh

Background MDA and Singapore HSA pilot 

The Malaysia Medical Device Authority (MDA) and Singapore Health Sciences Authority (HSA) had announced a regulatory reliance pilot between the two regulators (MDARIS#376|(17) MDA.6-2/1/4 JILID 5) at the ASEAN meeting in August 2025. The pilot lasted six months, from September 1 - February 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 time by 30 working days: CAB full conformity assessment review is 60 working days.

Medical devices registered with MDA full conformity assessment, could use an abridged HSA review in Singapore. This would reduce the review time by 30%. 

Successful completion of pilot and ongoing implementation

Based on the successful completion of the pilot, both the MDA and HSA remain committed to the regulatory reliance program.

Manufacturers may continue to use regulatory reliance to reduce the review times with the MDA or HSA. The HSA further clarified that if the device classification was different between the two regulators, the devices would not be within scope and Class D devices with ancillary registrable medicinal products. 

Concluding remarks

The implementation of this regulatory reliance program reflects a commitment between the MDA and HSA to rely on each other’s reviews, to reduce the review times.

Emergo by UL experts remain enthusiastic about regulatory reliance initiatives to efficiently and appropriately advance access of medical devices globally.