Proposed Mandatory Medical Device Registration — Legislative Reform
Hong Kong's Food and Health Bureau and Medical Device Division (MDD) have been developing a legislative framework to make medical device registration mandatory. Under the proposed framework, Class II, III, and IV devices would require registration with the MDD before they may be imported or supplied in Hong Kong — replacing the current voluntary MDACS listing scheme.
The reform aims to align Hong Kong with international regulatory standards and strengthen patient safety protections. Devices already listed under MDACS with conformity assessment evidence from recognised bodies (CE, FDA, TGA, etc.) would be well-positioned to transition to mandatory registration when required.
🔖 Status: under development / consultation
Manufacturers currently supplying devices in Hong Kong under the voluntary MDACS scheme should participate in any public consultations on the mandatory registration legislation and begin preparing their conformity assessment documentation now. Devices with valid CE marks, FDA clearances, or other internationally recognised approvals will likely have a streamlined pathway under the mandatory scheme.
View official source (MDD — Proposed Legislation) ↗