MDA–HSA MOU on Regulatory Reliance Pilot

The MDA and HSA have signed a Memorandum of Understanding (MOU) to launch a 6-month pilot of the Medical Device Regulatory Reliance Programme aimed at streamlining the registration of Class B, C and D medical devices. The MOU will run from 1st September 2025 until 28th February 2026. This collaboration allows both regulators to streamline approval pathways, set a clear procedure, validate shortened processing timelines and gather feedback from the stakeholders to build an effective and scalable regulatory reliance system. Under this programme, medical device in Malaysia had been registered with HSA may undergo a verification route (Abridged review pathway) through MDA's Conformity Assessment Body (CAB). This shortens the review period from 60 Working Days (WD) under full assessment to 30 WD with final registration completed within an additional 30 WD. Conversely, medical devices in Singapore that had been registered with MDA will benefit from an abridged review pathway by achieving up to 30% shorter review period across all Class B to Class D.

 

This strategic partnership between Malaysia and Singapore through MOU marks a milestone in cross-border regulatory collaboration and a testament to both countries' commitment to advancing the regional economic integration. At the end of this pilot, MDA and HSA will jointly evaluate the outcomes to assess the potential full-scale implementation in future.

 

Connect with our team to learn how this Malaysia–Singapore pilot programme could benefit your medical device registration strategy!

 

Reference

Joint Statement between MDA and HSA