• 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

醫療器械部將繼續進行試驗，以研究當地負責人（LRP）證明其醫療器械符合“醫療器械安全和性能的基本原則”的可行性。

• 2020-03-16 06:42:41

醫療器械部門將繼續進行試驗，以研究對當地負責人（LRP）的可行性，該試驗將持續到2020年12月31日，以用於有限數量的II / III / IV級普通醫療器械的上市申請。