Hong Kong GN-10 Edition 3 Defines 18 Non-reportable Changes

Hong Kong’s Medical Device Division (MDD) issued Edition 3 of Guidance Notes for Changes of Listed Medical Devices (GN-10:2026(E)), effective 26 June 2026. The notes apply to every device listed under the Medical Device Administrative Control System (MDACS). They are administrative guidance for Local Responsible Persons (LRPs), not legislation.

The principal operational addition is a new clause 5.3 list of changes that do not require reporting to MDD, provided they stay within that list and do not arise from a safety alert or adverse event or otherwise appear capable of affecting safety, quality, or performance (SQP). Major and Minor Change deadlines continue to apply, as does the rule that an unapproved or unnotified change can invalidate the listing.

What GN-10 is, and what it is not

GN-10 tells the LRP how to categorise, manage, and report changes to a listed medical device so that MDACS records stay current. A listed device that undergoes changes must remain in compliance with the Essential Principles of Safety and Performance.

MDACS is an administrative listing system. Losing listed status is not the same as a statutory prohibition on sale. If a Major Change is implemented without prior MDD approval, GN-10 says the device will no longer be regarded as listed, and the LRP must stop supplying it in a way that purports it is still listed — for example by displaying the HKMD number on the outer package or making that claim in promotional materials.

Rules that continue to apply

Edition 3 uses flowcharts in section 4 (manufacturing/QMS, design, sterilisation, software, materials, IVD materials, and labelling/Special Listing Information) to classify changes. Several flowcharts were revised in Edition 3, and GN-10 describes them as assessment tools rather than an exhaustive catalogue of every possible change.

The new list: changes that do not require reporting

Clause 5.3 is new. Changes limited to 5.3.1 through 5.3.18 do not require reporting to MDD. They must still be recorded in the manufacturer’s quality management system (QMS) and/or the device’s technical documentation.

That relief does not apply if the change results from a safety alert or adverse event, or “may be conceived to impact” SQP of the listed device. In those cases GN-10 says the change should be reported through MDIS as a Major or Minor Change.

The 18 items fall into four groups:

Component-level suppliers and sites, plus equipment changes without process changes

• Replacement, addition, or removal of raw-material suppliers, manufacturing sites, sub-contractors, or sterilisation facilities that are not engaged for production of the whole device, but only a part or constituting components (5.3.1–5.3.4).
• Replacement, addition, or removal of manufacturing equipment without a change to the manufacturing process (5.3.5).

Certificate or licence housekeeping that does not change the listed device

• Update of the validity of marketing-approval certificates, or of licences under local ordinance, without a change in the listed device (5.3.6–5.3.7).
• Addition in QMS-certificate scope, or a change in QMS-certificate validity, for the manufacturer or manufacturing site(s), where the change does not affect the listed device (5.3.8–5.3.11).

Contact details

• Change in the manufacturer’s contact person or telephone as recorded on the MDIS application form (5.3.12).
• Change in LRP contact details recorded in MDIS that does not change Special Listing Information. For that case, the LRP must update the information in MDIS rather than file a Change Application (5.3.13).

Routine document updates with no design, material, or labelling change

• Routine update of the Clinical Evaluation Report, Risk Management Report, Essential Principles Conformity Checklist (MD-CCL), IVD checklist (MDIVD-CCL), or the version of standards complied with, without a resulting design, material, or labelling change (5.3.14–5.3.18).

Other device changes must be classified under section 4 and reported as Major or Minor unless GN-10 specifies a different route. The exceptions include an LRP transfer (Takeover Application), delisting (Delisting Application), and a manufacturer name change (new listing application).

How Change Applications are filed

Change Applications are made through MDIS. If acknowledgement does not arrive within two weeks, the LRP should ask MDD whether the file was received.

Certificates must remain valid at the time of application. If a certificate expires during assessment, a renewed valid certificate must be submitted on request. An electronic certificate is acceptable if it carries a valid, verifiable electronic signature of an authorised person of the issuing organisation or regulatory authority, and authenticity can be verified on that issuer’s designated official website. Other electronic documents are acceptable if they carry a valid, verifiable electronic signature of an authorised person of the issuing company under the company domain, with a time-stamp.

Documents must be in Simplified Chinese, Traditional Chinese, or English. Other languages need a translation in English or Chinese; where the original is in neither language, both the original and a certified translation must be submitted. If asked to demonstrate translation accuracy, acceptable evidence is: the translation is covered by the supporting marketing approval(s); the translation was done by a provider certified to ISO 17100 or an equivalent standard; or a notary-public declaration that the version is an accurate representation of the original.

Two filing limits remain easy to miss:

1. Manufacturer name change requires a new listing application, not a Change Application.
2. MDD generally will not accept a second Change Application for the same device while one is still under evaluation. If two filings are unavoidable, the LRP must withdraw the open application and submit one new application covering all changes.

Results are rejected, approved, or approved conditionally, notified by letter via MDIS. Failure to comply with special conditions can result in removal of the names and the device from the Lists of Medical Devices. If a Change Application is rejected, the LRP must not proceed with the change; otherwise the listing becomes invalid immediately.

Appeals against rejection, listing conditions, or removal run to the Secretary to the Medical Device Administration Appeal Committee, c/o MDD, within 14 working days. An appeal lodged after that limit will not be considered. Lodging an appeal does not suspend the decision unless MDD decides otherwise.

Supplying original and changed versions together

If the LRP intends to supply the original and changed versions concurrently after a Major Change, the Change Application must include a proposed schedule. Following approval, the changed versions are supplied; the original version may be supplied concurrently only while it still complies with the Essential Principles. Unless MDD specifies otherwise, transition to the changed version must be completed within 24 weeks, or by another time instructed by MDD. The LRP must keep a way for users to distinguish versions (for example batch, lot, serial number, or expiry date) and retain supply records.

Delisting is a separate MDIS Delisting Application, not a Change Application.

What LRPs and manufacturers should do now

Pure Global’s recommended sequence, derived from Edition 3:

1. Review the change-classification SOP against clause 5.3. Map current “always file” items against 5.3.1–5.3.18 before assuming a Change Application is required.
2. Keep the SQP override in the same SOP. A 5.3 item that follows a safety alert or adverse event, or that could affect SQP, still goes through Major/Minor reporting.
3. Protect listed status. Major Changes wait for approval. Unnotified or unapproved changes can invalidate the listing immediately.
4. Do not use a Change Application for a manufacturer name change. File a new listing.
5. File only through MDIS, with valid certificates and the translation evidence MDD may request.
6. Plan concurrent supply in the Change Application with a proposed schedule and a 24-week transition unless MDD sets another period.

The official notice is on MDD’s 26 June 2026 MDACS activities page. The controlling text is GN-10:2026(E). For listing pathways under the same system, see Pure Global’s Hong Kong market page and the companion update on GN-02 and GN-06.