Hong Kong's MDACS framework recognises approvals from six major regulatory authorities, allowing manufacturers to shorten listing timelines while maintaining safety and quality.
Hong Kong’s MDACS framework adopts a reference regulatory approval model, recognizing approvals from several trusted foreign regulatory authorities. This approach enables manufacturers with existing approvals in major markets to streamline their Hong Kong listing process while maintaining high safety and quality standards.
According to MDACS guidance, HKMDD accepts approvals from the following authorities:
NMPA (China)
Health Canada
Singapore HSA
Australia TGA
U.S. FDA
EU CE (MDR/IVDR)
This recognition allows manufacturers to leverage prior regulatory evaluations, reducing duplication and accelerating time-to-market. However, Hong Kong still requires device-specific documentation, including labeling, IFU, risk management files, and appointment of a Local Responsible Person (LRP). While NMPA approvals and Production Licenses are accepted as part of QMS evidence, reviewers frequently request ISO 13485 certification to ensure the quality system aligns with international expectations — particularly for higher-risk devices.
For MedTech companies expanding into Asia, Hong Kong remains a strategic entry point due to its transparent regulatory structure, international alignment, and acceptance of multiple global approvals.
Sources:
MDACS — Recognized Regulatory Authorities
MDACS — Guidance Notes on Listing Requirements
