Asia-Pacific Regulatory News
Malaysia’s Medical Device Authority (MDA) and Singapore’s Health Sciences Authority (HSA) have launched a six-month pilot program aimed at accelerating approvals for Class B, C, and D medical devices. Running from 1 September to 28 February, the initiative is designed to shorten review times, reduce duplication, and speed up patient access to innovative medical technologies.
Under the scheme, devices already registered with HSA may undergo an abridged review by MDA’s conformity assessment body, cutting timelines to 30 working days compared to the standard 60-day review. Conversely, devices approved in Malaysia will benefit from an abridged review by HSA, reducing approval timelines by around 30%.
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The pilot will test streamlined regulatory pathways, refine SOPs, and validate shorter timelines, while collecting industry feedback. MDA CEO Muralitharan Paramasua described the collaboration as a way to “diversify market opportunities, strengthen technical confidence in the medical device regulatory system, and reinforce the close relationship between Malaysia and Singapore.”
This initiative follows Malaysia’s recent agreement with China’s National Medical Products Administration (NMPA), further positioning Malaysia as a hub for regulatory reliance frameworks in Asia.
Other Key Regulatory Updates
India (CDSCO) – Alert issued after theft of Novo Nordisk insulin products and GLP-1 obesity drug Wegovy in transit.
Philippines (FDA) – Clarified guidelines on compassionate use of unauthorized drugs and devices, rejecting calls for a renewal process.
India (CDSCO) – Deadline set for 1 March 2026 to include qualitative excipient details in bar/QR codes on packaging.
Philippines (FDA) – Warning issued about counterfeit vaccines circulating in the market, urging public vigilance.
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Role of Operon Strategist
In this evolving Asia-Pacific regulatory landscape, Operon Strategist plays a critical role in helping medical device and pharmaceutical manufacturers:
- Navigate cross-border reliance pathways like the Malaysia-Singapore pilot for faster market entry.
- Ensure regulatory compliance with CDSCO, HSA, MDA, and FDA requirements.
- Implement supply chain security and anti-counterfeit strategies for high-risk products.
- Adapt to new labeling, serialization, and QR code mandates in India and beyond.
- Support compassionate use and expanded access programs in the Philippines and other regions.
With expertise in global regulatory consulting, facility setup, and quality management systems, Operon Strategist enables manufacturers to achieve faster approvals, safer product launches, and sustainable international growth.
