HSA, Malaysia’s MDA launch joint effort to streamline medical device regulation

Both agencies will use each other’s reviews to speed up device approvals.

Singapore’s Health Science Authority (HSA) and Malaysia’s Medical Devices Authority (MDA) have launched the first regulatory reliance pilot for medical devices.

The six-month pilot of the Medical Device Regulatory Reliance Programme, running from 1 September 2025 to 28 February 2026, aims to expedite market access for Class B, C, and D medical devices by reducing duplicate regulatory reviews and leveraging each other's approvals.

The reliance programme is expected to help manufacturers in Singapore with up to 30% shorter review times across multiple device categories.

Such efficiency gains are expected to encourage more cross-border filings, reduce time-to-market, and improve patient access to new technologies.

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