SINGAPORE — Malaysia's Medical Device Authority (MDA) and Singapore's Health Sciences Authority (HSA) have signed a Memorandum of Understanding and launched a pilot of a Medical Device Regulatory Reliance Programme, in a move designed to speed up cross-border market access. The agreement was formalised on 22 August 2025.
What the pilot does
Under the six-month pilot, running from 1 September 2025 to 28 February 2026, each regulator can rely on the other's assessments and approvals rather than duplicating the full review. The scheme covers higher-risk device classes (Class B, C and D) and is intended to cut both cost and time-to-market.
Expected benefits
- Faster registration through mutual recognition of regulatory work already done.
- Reduced duplication and lower compliance costs for manufacturers and distributors.
- Earlier patient access to safe, innovative medical technologies in both markets.
At the end of the pilot, the two agencies plan to evaluate the results and consider full-scale implementation. For companies supplying medical devices across ASEAN, a working reliance pathway between two of the region's most active regulators could meaningfully streamline how renal-care and hospital equipment reaches patients in Malaysia and Singapore.
