Malaysia and China have signed a landmark mutual recognition agreement to fast-track medical device approvals between the two countries, effective 30 July 2025. The 2025 Regulatory Reliance Programme enables Malaysian IVDs to access China’s Green Channel and allows Chinese devices to enter Malaysia via an accelerated 30-day review.
Malaysia’s Medical Device Authority (MDA) and China’s National Medical Products Administration (NMPA) have launched the 2025 Medical Device Regulatory Reliance Programme—the first bilateral mutual recognition agreement of its kind.
Effective 30 July 2025, this initiative fast-tracks pre-market approvals by allowing both countries to recognize each other’s regulatory decisions. This means:
This agreement supports faster market access, avoids redundant reviews, and strengthens Malaysia’s position as a regional regulatory hub.
This programme benefits both multinational and local manufacturers by:
Malaysia continues to champion regulatory reliance, aligning with AMDD principles and supporting global health innovation.
Industry stakeholders are encouraged to consult with MDA Malaysia for eligibility and submission pathways. Early engagement is recommended to prepare for the 30 July 2025 launch.
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