The Medical Device Division (MDD) of the Department of Health, Hong Kong, has updated the Guidance Notes for Definitions and Abbreviations for Medical Device Administrative Control System (GN-00), with the revised version taking effect on 13 May 2026. While the update includes amendments to the definition of a medical device, the most notable change is the introduction of Appendix 1, which designates specific products as medical devices under the Medical Device Administrative Control System (MDACS).
Key Changes Introduced in the Updated GN-00
- The revised GN-00 updates Clauses 2.38, which defines a medical device under MDACS. Among the changes, the term "in vitro reagent or calibrator" has been revised to "reagent for in vitro use", broadening and clarifying the terminology used for in vitro diagnostic (IVD) products.
- A new provision has been added under Clause 2.38(b), which expands the definition of medical device to include "any items listed in Appendix 1".
Why Appendix 1 Matters
As healthcare technologies evolve and the boundaries between medical, aesthetic, cosmetic, and wellness products continue to blur, regulatory authorities worldwide are increasingly adopting approaches that allow specific product categories to be regulated based on their risk profile and intended use.
Importantly, Appendix 1 creates a framework that can accommodate future additions. While only one product category is currently listed, manufacturers should recognize that other products may be added through future revisions.
Dermal Fillers Become the First Products Listed in Appendix 1
At present, Appendix 1 contains a single category:
Injectable dermal fillers or mucous membrane fillers.
These products are now explicitly regulated as medical devices under Clause 2.38(b) of the MDACS. The inclusion of dermal fillers reflects increased international regulatory scrutiny of aesthetic injectables. Although commonly associated with aesthetic procedures, these products pose significant health risks if improperly manufactured, distributed, or administered. Potential clinical complications include infection, vascular occlusion, tissue necrosis, product migration, and inflammatory reactions.
By specifically listing injectable dermal fillers and mucous membrane fillers in Appendix 1, the MDD has clarified their regulatory status within Hong Kong's medical device framework. Manufacturers of these products should assess whether their existing regulatory strategy remains appropriate and determine whether additional compliance or registrations activities may be required under MDACS.
Implications for Manufacturers and Local Responsible Persons
The revised GN-00 highlights the importance of continuously monitoring regulatory developments and reassessing product portfolios against updated definitions and requirements.
- Manufacturers should review their products to determine whether they are directly affected by the Appendix 1 addition or whether future updates could potentially impact other products within their portfolio. Key considerations may include product intended use, labeling claims, technical documentation, and applicable regulatory classifications.
- For LRPs, the update reinforces the need for ongoing regulatory surveillance. As the primary regulatory representative for overseas manufacturers under MDACS, LRPs should be prepared to identify newly regulated products, advise clients on compliance obligations, and support registration planning where necessary.
Details updates on medical device definitions and abbreviations for MDACS can be referred to the following updated links: [GN-00] Guidance Notes for Definitions and Abbreviations for Medical Device Administrative Control System
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