Hong Kong recognises the NMPA as a reference regulatory authority, giving China-based manufacturers a streamlined pathway into the HK market under MDACS.
Hong Kong recognizes China’s National Medical Products Administration (NMPA) as a reference regulatory authority, enabling NMPA-approved medical devices to be listed under MDACS. This policy provides a streamlined pathway for China-based manufacturers seeking entry into Hong Kong’s market.
MDACS also accepts the NMPA Production License as one form of Quality Management System (QMS) evidence. However, in practical review, HKMDD reviewers frequently request ISO 13485 certification to ensure full alignment with international QMS expectations and to support completeness of the technical documentation.
While NMPA approval accelerates the listing process, manufacturers must still provide Hong Kong-specific documentation, including device labeling, IFU, risk management files, and appointment of a Local Responsible Person (LRP). The combination of NMPA recognition and Hong Kong’s structured listing requirements positions Hong Kong as a bridge between Mainland China and global markets.
Sources:
MDACS — Useful Information
MDACS — Acceptance of NMPA Production License
NMPA — Medical Device Regulatory Framework
