On May 13, 2026, the Medical Device Division (MDD) issued a revised edition of Guidance Notes GN-00: Definitions and Abbreviations for the Medical Device Administrative Control System (MDACS).
GN-00 is a foundational document that provides standardized definitions and abbreviations used across MDACS guidance notes, technical references, and codes of practice, ensuring consistent interpretation of regulatory terminology.
Recent updates, including Edition 5 dated May 04, 2026, and Edition 6 dated May 13, 2026, aim to strengthen the clarity, structure, and usability of definitions within the MDACS framework.
Read the full update here:
https://www.mdd.gov.hk/en/whats-new/mdacs-activities/index-id-2363.html
Purpose of the Revision
To update and clarify the definitions and abbreviations used under the Medical Device Administrative Control System (MDACS).
To support consistent interpretation of regulatory terminology across MDACS guidance notes, technical references, and codes of practice.
Scope of Application
This revision applies to manufacturers, Local Responsible Persons (LRPs), and applicants preparing medical device documentation, labeling, and regulatory submissions under MDACS.
Key Highlights
Recent updates to GN-00 include:
- Formatting revision to Clause 2.38, the definition of medical device, to enhance clarity and readability
- Revisions to Clause 2.38.7 to align with the IMDRF/GHWP definition of a medical device
- Introduction of a new Appendix 1, providing supplementary reference information to Clause 2.38
These updates aim to strengthen the clarity, structure, and usability of definitions within the MDACS framework.
References
Read to learn more:
- English version: GN-00: Definitions and Abbreviations for MDACS [PDF]
- Chinese version:https://www.mdd.gov.hk/filemanager/common/mdacs/GN-00-C.pdf
Implications to Clients
The latest revision introduces updates in relation to the definition and interpretation of a medical device, as well as additional reference support through Appendix 1.
Manufacturers are advised to:
- Review the updated Clause 2.38, Medical Device, to ensure alignment with product scope and regulatory interpretation
- Refer to Appendix 1 for supplementary guidance when interpreting definitions under Clause 2.38
- Ensure consistency of terminology across technical documentation, labeling, and regulatory submissions
While earlier recent editions, including Editions 4 and 5, were limited to editorial updates, this latest revision introduces clarifications that may be relevant for borderline or combination product assessment and regulatory positioning under MDACS.
Effective Date
Immediate
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Hong Kong, please contact info@nordpacificmed.com.