Injectable and infusible products are now formally classified as medical devices under MDACS in Hong Kong. Manufacturers and distributors must initiate MDACS listing applications and update PHF customers promptly.
The Department of Health (DH) has issued an important regulatory update regarding the use of injectable and infusible products in licensed Private Healthcare Facilities (PHFs).
DH has formally defined these products as medical devices under the Medical Device Administrative Control System (MDACS), with mandatory compliance required by 1 March 2027. This policy change directly affects manufacturers, distributors, importers, and PHFs using injectable products such as dermal fillers and mucous membrane fillers.
Mandatory MDACS Listing Requirement
To enhance patient safety and ensure the use of compliant medical devices in clinical settings, DH announced that all injectable and infusible medical devices used in licensed PHFs must be listed under the Medical Device Administrative Control System (MDACS) by the effective date.
The requirement covers:
Injectable dermal fillers
Injectable mucous membrane fillers
Other injectable or infusible medical devices used in PHFs
DH has formally defined these products as medical devices under MDACS through updates to the Guidance Notes for Definitions and Abbreviations (GN‑00).
Key Actions Required for Traders and Manufacturers
DH strongly advises all traders, distributors, and manufacturers to begin preparations immediately:
1. Initiate MDACS Listing Applications
Engage with product manufacturers to arrange MDACS listing submissions for injectable and infusible products that are not yet listed.
2. Update PHF Customers
Communicate the MDACS listing status of relevant products to PHF clients and support their transition to compliant alternatives before 1 March 2027.
3. Verify Compliance Before Supply
All parties should verify compliance before supply or use.
Transition Timeline
DH has provided a transition period to allow PHFs sufficient time to identify and source compliant alternatives. Given the expected increase in MDACS applications, early preparation is recommended to avoid supply disruption.
If your organisation supplies injectable or infusible products to PHFs, or if you are preparing MDACS submissions for Hong Kong market access, AlphaMedic can support your regulatory planning, classification assessment, and compliance strategy ahead of the 1 March 2027 deadline.
Sources:
Department of Health — Update on Regulatory Requirements on the Use of Injectable and Infusible Products in Licensed PHFs
