MDACS — Medical Device Administrative Control System (Voluntary Scheme)
Hong Kong's Medical Device Administrative Control System (MDACS), administered by the Medical Device Division (MDD) of the Department of Health, is currently a voluntary scheme for medical device listing. Unlike most major markets, Hong Kong does not currently have mandatory pre-market registration for medical devices — however, devices listed under MDACS demonstrate alignment with international safety and performance standards and are required or preferred for procurement by public hospitals and government healthcare institutions.
MDACS classification follows the risk-based framework:
- Class I (lowest risk) — Self-declaration; no product listing required
- Class II, III, IV (higher risk) — Voluntary product listing; evidence of conformity assessment (CE mark, FDA clearance, TGA registration, or equivalent) required
The Hong Kong government has been consulting on introducing mandatory device registration legislation to replace the voluntary scheme. This reform, if enacted, would align Hong Kong more closely with other major regulatory frameworks.
📅 Effective / published: MDACS operational; mandatory reform under consultation
Manufacturers supplying devices to Hong Kong public hospitals or government healthcare buyers should list applicable devices under MDACS. Monitor the Department of Health and Food and Health Bureau announcements for updates on the proposed mandatory registration legislation, which could significantly change market access requirements.
View official source (MDD — MDACS) ↗