• 2026-07-27 02:32:02

The Hong Kong MDD has revised its Guidance Notes (GN-00), effective 13 May 2026. The update introduces Appendix 1, officially classifying injectable dermal and mucous membrane fillers as medical devices under MDACS. Manufacturers, LRPs, and consultants must evaluate this expansion due to immediate compliance and registration requirements.

• 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.

• 2024-11-04 10:27:21

Starting from 1 January 2025, Local Responsible Persons must submit Medical Device Listing Renewal Applications between 12 weeks and 1 year before the expiry of their listing approval. Applications that fail to reach MDD before the 12-week mark will not be processed.

• 2024-09-17 05:14:36

Hong Kong's Department of Health will be implementing an enhanced two-staged strategy following the previous phase, to prioritize Medical Device Administrative Control System (MDACS)-listed medical devices in public healthcare facilities procurement. This article outlines the new requirements, and how to navigate the impacts.

• 2024-09-17 03:42:57

The Expedited Approval Scheme for Medical Device Listing Applications has been expanded to include Class B/C/D In Vitro Diagnostic Medical Devices. Eligibility criteria remain unchanged, while some additional regulatory agencies have been recognized. Applications must be submitted through Medical Device Information System and refers to both GN-02 and GN-06.

• 2024-05-08 01:49:59

In April 2024, Hong Kong Medical Device Division has introduced the new Medical Device Information System, a one-stop e-service that allows online Medical Device Administrative Control System listing applications for medical devices and traders. It is highly recommended to familiarize with the new e-services, as we transition out of paper-based submissions.

• 2024-06-20 05:49:36

In a significant step towards regional harmonization, the Hong Kong MDD announced on 2 April 2024, that they now recognize marketing approvals for Class II, III, and IV medical devices issued by Singapore's Health Sciences Authority (HSA) This means manufacturers with existing HSA approvals can now use them to support their applications for registration in Hong Kong, potentially saving significant time and resources.

• 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.

• 2024-04-08 07:44:40

Last February 19, 2024, Hong Kong Medical Device Division has published a Supplementary Information Sheet (MD111) to strengthen procurement strategy with the Hospital Authority (HA). HA procured devices seeking to be listed under Medical Device Administrative Control System can provide supplementary information through this form for regulatory authorities’ consideration.

• 2024-03-01 08:29:27

Starting from 1 January 2024, Hong Kong Medical Device Division (MDD) has accepted on a regular basis marketing approvals from the Ministry of Food and Drug Safety (MFDS) of South Korea and National Medical Products Administration (NMPA) of Mainland China to support the listing application of medical devices in Hong Kong.