Malaysia: MDA, HSA, Forge Closer Ties with pilot Medical Device Regulatory Reliance Programme (1 Sept 2025 - 28 Feb 2026)

22 August 2025 marked a milestone moment for the medical device industry in Southeast Asia, as the Medical Device Authority (MDA) and the Health Sciences Authority (HSA) signed a Memorandum of Understanding (MOU) to strengthen regulatory cooperation. The agreement was formalised during the 14^th ASEAN Medical Device Committee (AMDC) Meeting in Siem Reap, Cambodia, and was accompanied by the launch of a 6-month pilot Medical Device Regulatory Reliance Programme.

Running from 1 September 2025 to 28 February 2026, this pilot programme aims to accelerate market access for Class B, C, and D medical devices by leveraging regulatory reliance between both countries.

What The Programme Brings to the Industry

The pilot programme reflects a shared vision of regulatory convergence, where both authorities will:

• Streamline approvals by relying on each other’s regulatory assessments

• Reduce duplication of reviews, cutting costs and time-to-market

• Enable faster patient access to safe, high-quality, and innovative medical technologies

  
  

By testing new streamlined pathways and refining standard operating procedures (SOPs), both regulators aim to validate shorter processing timelines and gather industry feedback. This will help build a scalable and effective long-term framework for regulatory reliance across the region.

Benefits for Medical Device Registration Certificate Holders

For companies seeking registration in Malaysia or Singapore, the pilot opens up faster and more efficient review processes:

• In Malaysia: Devices already registered with HSA may undergo a verification (abridged) route through MDA’s Conformity Assessment Body (CAB). Reviews could take 30 working days instead of the usual 60, with final registration completed within another 30 days

• In Singapore: Devices registered with MDA will benefit from an abridged review pathway, cutting review times by up to 30% for Class B, C, and D

This MOU and pilot programme reflect both countries’ commitment to fostering regulatory alignment, supporting industry growth, and enhancing patient access to advanced medical technologies. At the end of the 6-month trial, MDA and HSA will jointly assess the outcomes and consider a full-scale implementation of the reliance programme.

For industry stakeholders, this initiative signals a new era of cross-border regulatory collaboration, paving the way for greater efficiency, innovation, and integration in the ASEAN medical device landscape.

Source: Medical Device Authority (MDA)