Snapshot

The Singapore Priority Review Scheme and Regulatory Reliance (with Malaysia) pathway has been developed by the of Singapore.

This pathway can be used where Applies to Class B, C, and D medical devices including IVDs, offering expedited review and market entry. Class A: Low risk (exempt from mandatory registration but listed). Class B: Low moderate risk. Class C: Moderate high risk. Class D: High risk. Enables regulatory reliance, permitting devices registered in one jurisdiction with abridged review in the other. ex: Devices approved by HSA can be fast-tracked in Malaysia via a 30-working-day abridged review versus 60 days in a full review, similarly reduced timelines in Singapore for Malaysian-registered devices. .

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from Malaysia

Target time assessment is .