Regulatory Update: Hong Kong

Announcement on the Medical Device Administrative Management System Accepting Sales Approval from the National Medical Products Administration and the Korean Food and Drug Safety Agency

In a significant move towards fostering international collaboration and ensuring the highest standards of safety and performance, the Hong Kong Medical Device Division (MDD) has recently made a groundbreaking announcement regarding the acceptance of marketing approvals for medical devices and instruments.

Starting from January 1, 2024, the MDD will consistently recognize sales approvals from the National Medical Products Administration in Mainland China for medical devices adhering to the "Basic Principles of Safety and Performance" of the Medical Device Administrative System (MDACS) (Technical Reference: TR-004).

Furthermore, as of January 1, 2024, the Medical Instrument Division will routinely acknowledge existing sales approvals from the Korean Food and Drug Safety Agency (MFDS) to support compliance with the MDACS "Basic Principles of Safety and Performance" (Technical Reference: TR-004) for medical instruments.

For the full resource, available in Chinese and English, please visit here.