Hong Kong GN-02 and GN-06 Listing Guidance Now in Force

Hong Kong’s Medical Device Division (MDD) has issued GN-02:2026 (E)(Ed. 1.0) and GN-06:2026 (E)(Ed. 1.0), the listing guidance notes now in force for Class II/III/IV general medical devices and Class B/C/D in vitro diagnostic medical devices (IVDs). The 31 July 2026 notice states that the updated notes are effective from that date.

The same notice says medical device listing applications already submitted through the Medical Device Information System (MDIS) will not be affected and need not be resubmitted.

These are Guidance Notes under the Medical Device Administrative Control System (MDACS). They tell Local Responsible Persons (LRPs) how to prepare a listing application. They are not a statute, and MDACS listing is not a statutory product registration.

Which 2026 revision is in force

The PDFs on MDD’s site are labelled GN-02:2026 (E)(Ed. 1.0) and GN-06:2026 (E)(Ed. 1.0). Their revision histories record two 2026 steps that must be kept separate:

This article describes the 31 July 2026 texts now posted. It does not reconstruct the 12 June wording of clauses 6.4, 8.3, and 8.4, because those prior files are not posted beside the current PDFs. Where a rule below comes from the 12 June package and remains in the current editions (Novo Lane, Expedited Approval Scheme, Hospital Authority fields), that is identified as part of the in-force 2026 notes rather than as a 31 July invention.

Who may apply, and how

Only the LRP of the device may apply. A manufacturer with a registered place of business in Hong Kong may act as LRP or designate another eligible body. A manufacturer without that Hong Kong presence must designate an external body that meets the LRP requirements.

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 sufficient 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 sufficient if they carry a valid, verifiable electronic signature of an authorised person of the issuing company under the company domain, with a time-stamp.

Language and translation evidence (clause 8.3)

Clause 8.3 is one of the three clauses the 31 July revision history marks as revised. In the current texts, all documents must be in Simplified Chinese, Traditional Chinese, or English. Documents in other languages must be accompanied by a translation in English or Chinese. Where the original is in neither English nor Chinese, both the original and its translation must be submitted. All versions must be consistent.

Where applicable, translation accuracy must be demonstrated upon request by any of:

• the translated version is covered by the supporting marketing approval(s);
• the translation was conducted by a service provider certified to ISO 17100 or an equivalent standard; or
• a declaration administered by a notary public that the version is an accurate representation of the original document.

Clause 8.4 is the form-completion table (MD101 or MD102). The article does not treat every table row as a 31 July novelty.

Novo Lane and the Expedited Approval Scheme

Both current form guides include Novo Lane and the Expedited Approval Scheme. Novo Lane eligibility does not replace the need for an MDACS Conformity Assessment Certificate (D001) and/or reference marketing-approval certificates (D002). Expedited processing requires two or more valid, independent marketing approvals from the jurisdictions specified in D002.

Novo Lane (form item E001) prioritises processing (GN-02) or approval (GN-06) of eligible innovative devices. At least one criterion must be met:

1. a device with a unique feature and without existing equivalence on the market (“First-of-its-kind”);
2. a referenced marketing approval obtained under an innovation channel (examples: NMPA’s 創新器械名錄, or FDA de novo) within the preceding five years;
3. a device with AI features approved to be marketed within the preceding five years; or
4. a device whose core technology was patented within the preceding five years.

The applicable checkbox(es) must be selected, with supporting documents and a description of the innovative features and clinical benefits. If the device is not eligible, the checkboxes are left blank.

Expedited Approval Scheme (form item E002) applies only if all of the following are met:

1. the applicant is an LRP with a valid LRP listing number;
2. there are no reported deaths or serious injury associated with the device, locally and worldwide;
3. there are no active recalls, field safety corrective actions, or adverse events, locally and worldwide; and
4. all devices in the application are supported by two or more valid, independent marketing approvals from the jurisdictions specified in D002.

Participation is initiated by default. The checkbox is selected only to opt out.

The notes do not state a shorter processing timeframe for either track. Clause 5.3.1 retains the qualified expectation that vetting and approval should normally be completed within 12 weeks after the application and all required supporting information have been submitted.

Hospital Authority procurement fields

Where, to the best of the applicant’s knowledge, the device has been procured by the Hospital Authority within the preceding 12 months, the application must give the purchase-order number, purchase-order date, and the supplier name on the purchase order (form item E003).

After MDD acknowledges the application, the applicant “is welcome to” update MDD via MDIS if the device later comes to be procured by the Hospital Authority, quoting the same three fields.

Appeals (including clause 6.4)

The LRP may appeal a Medical Device Listing Approval Board decision to reject an application, to impose conditions on a conditional approval, or to remove a listed device, within 14 working days of being notified. The appeal is written to the Secretary to the Medical Device Administration Appeal Committee, c/o MDD.

Lodging an appeal does not suspend the decision unless MDD decides otherwise. Clause 6.4, which the 31 July history marks as revised, currently reads: an appeal lodged after the time limit specified above will not be considered. The LRP is to be notified of the outcome within four weeks after the appeal and all required supporting information are submitted. The Appeal Committee’s decision is final.

What applicants should do now

Pure Global’s recommended sequence, derived from the 31 July notice and the posted Ed. 1.0 texts:

1. Do not resubmit a file already in MDIS unless MDD asks. The 31 July notice says those applications are unaffected.
2. Use the current MD101 or MD102 in MDIS for any new listing. Only the LRP can apply.
3. Decide Novo Lane and Expedited status on evidence, not on marketing language. Novo Lane still needs D001 and/or D002. For an application that meets all four Expedited criteria, participation is initiated by default; select the checkbox only if the applicant chooses to opt out.
4. Budget the 12-week clock as a “normally” figure that starts only when requested supporting information is complete. Missing information can close the application.
5. Prepare translation evidence in advance if any source document is not in English or Chinese.
6. Record Hospital Authority purchase-order data when the device was procured in the last 12 months, and update MDIS if procurement happens after filing.

The controlling documents are GN-02:2026 (E)(Ed. 1.0) and GN-06:2026 (E)(Ed. 1.0). For change control after listing, see GN-10 Edition 3. For the wider MDACS pathway, see Pure Global’s Hong Kong market page and MDD glossary entry.