• 2025-12-26 02:17:11

The Hong Kong Department of Health (DH) is enhancing its medical device procurement strategy under MDACS. Following the implementation of Stage B on 1st November 2024, DH will introduce Stage C which will take effect on 23 March 2026. Under this enhanced measure, all applicable medical devices classified as Class II-IV or B-D procured by DH must be listed under MDACS. This policy aims to strengthen public health protection by ensuring the safety, quality and performance of medical devices used in public healthcare facilities, while also promoting wider adoption of MDACS in preparation for future statutory regulation.

• 2024-06-19 06:31:24

Starting 13 May 2024, Hong Kong Medical Device Division has excluded non-clinical devices from Medical Device Administrative Control System’s scope. Custom-made medical devices have also been excluded from this scope since 2 April 2024, and marketing approvals from Health Sciences Authority - Singapore has been accepted to support listing applications.

• 2020-04-14 01:28:54

The Medical Device Division will continue the trial to study the feasibility for Local Responsible Persons (LRP) to prove their medical device conform the “Essential Principles of Safety and Performance of Medical Devices” .

• 2020-03-16 06:42:41

The Medical Device Division will continue the trial to study the feasibility for Local Responsible Persons (LRP),the trial will last until 31 December 2020 for a limited number of listing applications of Class II/III/IV general medical devices.