Snapshot

The China Green Channel for Medical Device Approval & Pilot with Malaysia pathway has been developed by the of China.

This pathway can be used where Green Channel accelerates approval for high-priority medical devices including innovative or rare-disease IVDs. China-Malaysia pilot allows Chinese-made Class II and III IVDs to obtain faster market entry in Malaysia via the Verification Pathway. Pilot program scope limited to: Class II devices approved at provincial MPA level. Class III devices approved at NMPA (national) level. Manufacturer eligibility requires local facility ownership and direct manufacturing (no third-party rebranding). .

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 .