The Medical Device Division (MDD) of the Hong Kong Department of Health has announced revisions to the Guidance Notes for Listing Class II/III/IV General Medical Devices (GN-02) and Guidance Notes for Listing Class B/C/D In Vitro Diagnostic Medical Devices (GN-06) under the Medical Device Administrative Control System (MDACS).
The latest revisions introduce clarifications and refinements following the significant updates made in June 2026.
Read the full update here:
Department of Health | Medical Device Division – MDACS Activities – 2026-07-31 (2367)
Purpose of the Update
To announce revisions to GN-02 and GN-06 under the Medical Device Administrative Control System (MDACS).
To clarify application requirements, appeal procedures, translation expectations, classification information, software documentation, and reference market approval evidence for the listing application of medical devices and IVD medical devices.
Scope of Application
This update applies to manufacturers and Local Responsible Persons (LRPs) submitting listing applications for:
- Class II/III/IV general medical devices under GN-02
- Class B/C/D in vitro diagnostic medical devices under GN-06
Key Updates
Revised Clause 6.4 – Lodging of an Appeal
The wording has been revised to clarify that appeals submitted after the prescribed appeal period will not be considered.
Revised Clause 8.3 – Translation Requirement
The MDD now expressly requires that all submitted document versions and their translations remain consistent with one another.
Revised Clause 8.4 – Guide to Application Forms MD101 and MD102
Several application requirements have been clarified or strengthened for both medical device and IVD applications.
Common Changes Applicable to MD101 and MD102
A003 – Manufacturer’s QMS
Clarified that where a KGMP certificate is submitted as evidence of QMS compliance, a valid Medical Device Product Licence issued by the Korea Ministry of Food and Drug Safety (MFDS) shall also be provided as the reference market approval in Part D.
C008 – Device Grouping and Classification
The update clarifies that relevant characteristics of the device supporting the proposed classification shall be indicated where applicable.
All classification-related information must be consistent with submitted technical documentation and labelling.
Applications containing models with distinguishing characteristics may be split into separate submissions.
C017 (MD101) / C018 (MD102) – Image of Software as a Medical Device (SaMD)
Representative screen captures specifying the software version shall be submitted.
D002 – Foreign Market Approval from Korea
The Certificate of Free Sale has been replaced with the MFDS Medical Device Product Licence as the primary supporting approval document.
The Certificate of Free Sale shall be submitted upon request.
E001 – Innovative Device Pathway
The innovation prioritization pathway has been formally renamed “Novo Lane”.
Devices applying through Novo Lane shall continue to comply with MDACS conformity assessment requirements or be supported by recognised reference market approvals under Part D.
MD102 Specific Changes for In Vitro Diagnostic Medical Devices
D002 – EU IVDD Self-Declared Devices
The update clarifies that Device Registration Records from the database of an EU Competent Authority may be submitted as an alternative to the associated Certificate of Free Sale.
References
Read to learn more:
- [GN-02] Guidance Notes for Listing Class II/III/IV General Medical Devices
- [GN-06] Guidance Notes for Listing Class B/C/D In Vitro Diagnostic Medical Devices
Implications to Clients
The July 2026 revision primarily refines the implementation of the major June 2026 MDACS reforms.
Manufacturers and Local Responsible Persons (LRPs) should review translation controls, classification rationales, software documentation, and overseas approval evidence to ensure compliance with the updated requirements.
Particular attention should be given to consistency across submitted documents, translations, technical documentation, labelling, device classification, and reference market approval evidence.
Effective Date
Immediate
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Hong Kong, please contact info@nordpacificmed.com.