The Medical Device Division (MDD) of the Department of Health, Hong Kong, has revised the Guidance Notes for Changes of Listed Medical Devices (GN-10), effective 26 June 2026. The revision introduces changes that affect how manufacturers and Local Responsible Persons (LRPs) manage post-listing changes for medical devices under the Medical Device Administrative Control System (MDACS).

The revision introduces new categories of changes that do not require reporting to the MDD, revised criteria for determining major changes, a new application outcome for change submissions, and additional compliance requirements. Manufacturers and LRPs should review these changes promptly to ensure seamless alignment with the updated requirements.

New Non-Reportable Changes Introduced

One of the most practical updates in the revised GN-10 is the introduction of Clause 5.3, which specifies changes that do not require reporting to the MDD. This addition helps reduce unnecessary regulatory submissions for administrative or routine updates that do not impact the safety, quality, or performance of the listed medical device. Examples of non-reportable changes include:

1. Change in validity date of QMS certificate of the manufacturer which does not affect the listed medical device
2. Replacement of equipment used in manufacturing process without change to manufacturing process
3. Replacement of sterilization facility from Company "A" to Company "B" that not engaged for production of the whole medical device, but just a part of the medical device
4. Change of raw material suppliers not engaged for production of the whole medical device but just a part of the medical device in IVD and general medical device.
5. Routine Update of Clinical Evaluation Report without resulting in design / material / labelling change to the listed medical device
6. Routine Update of Risk Management Report without resulting in design / material / labelling change to the listed medical device
7. Update of validity of marketing approval certificates without change in the listed medical device

Revised Criteria for Major Changes

The revised GN-10 also updates several flowcharts used to determine whether a change is considered Manufacturing and Design Changes.

1. Manufacturing and Design Changes

1. For manufacturing-related changes, the guidance specifies that any addition, deletion, or change to manufacturing facilities involving changes to the manufacturing process is categorized as a major change. [4.3(b) (Flowchart A)]
2. For design-related changes, the criteria have been revised to state that if a change requires additional preclinical and/or clinical data to support its safety, it is categorized as a major change. [4.3(c) (Flowchart B)]

2. Biological Materials and Device Materials

The wording for certain material-related changes has been revised from "or" to "and/or" for changes involving the type, source, processing, and/or supplier of biological materials, as well as changes to materials that result in changes to the design and/or specifications of a medical device. [4.3(f) (Flowchart E)]

3. Labeling Changes

1. The revised guidance specifies that changes to indications for use in the labeling of the device that are not included in the approved indications are categorized as major changes. Besides, additions, deletions, and revisions to contraindications, warnings, precautions, and side effects listed on the device labeling are also considered major changes. [4.3(h) (Flowchart G)]
2. If there are other changes to the LRP contact information that do not affect the specific listing information for the registered device, manufacture should update that information in MDIS. [4.3(h) (Flowchart G)]

New Application Outcome: Approved Conditionally

The revised GN-10 introduces a 'conditional approval' outcome for change applications. Under this updated guidance, approvals may be granted subject to specific conditions communicated via the Medical Device Information System (MDIS). Applicants must fulfill these requirements within the stipulated timeframe; failure to comply may result in the delisting of both the applicant and the medical device from the MDACS.

Additional Requirements for Submitted Documents

The revised GN-10 introduces additional requirements for document submissions.

1. Certificates submitted to the MDD must remain valid at the time of application, and renewed certificates may be requested if they expire during the assessment process.
2. Electronic certificates and documents are acceptable if they contain valid and verifiable electronic signatures.
3. Documents submitted in languages other than Simplified Chinese, Traditional Chinese, or English must be accompanied by an English or Chinese translation with appropriate supporting evidence.

Compliance with the Prevention of Bribery Ordinance.

The revised GN-10 introduces a new section on compliance with the Prevention of Bribery Ordinance. Applicants and their employees or agents must not offer an advantage as defined in the Prevention of Bribery Ordinance (Chapter 201) to any government officer in connection with their applications or while having dealings of any kind with government departments.

Details updates on changes of listed medical devices can be referred to the following updated links: [GN-10] Guidance Notes for Changes of Listed Medical Devices

Apply now!

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Reference

[GN-10] Guidance Notes for Changes of Listed Medical Devices