GN-02 listing application document checklist, item by item

1. Key takeaways

The overview of the official listing process sets out 12 categories of documents that a listing application must contain: the manufacturer’s letter appointing its local responsible person; the applicant’s valid Hong Kong, China business registration certificate; a certificate issued by a conformity assessment body, known as a CAB certification review certificate (Route 1 only); marketing approval documents from a reference jurisdiction (Route 2 only); an ISO 13485 certificate or equivalent evidence; a completed Essential Principles checklist or an Essential Principles declaration; a clinical evaluation report for a general medical device or a performance evaluation report for an in vitro diagnostic medical device; device labelling, covering instructions for use, manuals, labels and specific listing information; any Hong Kong, China licence that applies, such as a licence under Chapter 303, the Radiation Ordinance; and other technical documentation. Every application must be submitted electronically through the Medical Device Information System (MDIS).

The value of the list is that it separates what is fixed from what is conditional. Some items every applicant must supply whatever route is chosen; two items are alternatives because they belong to different conformity routes; and the remainder scale with the device, its class and its technology.

• The list is dual-track, and only one track applies. A CAB certificate serves Route 1, a reference jurisdiction approval serves Route 2. Preparing both is wasted effort, and eligibility should be settled before dossier work starts.
• The revision of 1 September 2026 changed the form of what is filed. Paragraphs 5.6.2–5.6.3 of GN-01 now address validity at submission, replacement during review and the acceptability of electronic certificates.
• Other technical documentation is the flexible item and the most common cause of requests for further information. It has no fixed content and depends on risk class and technical characteristics.
• A local licence is a parallel obligation. A device involving radiation needs a Chapter 303 licence in addition to listing, and listing does not waive it.

2. Legal basis

The list itself comes from the MDD publication Overview of the Medical Device Listing Process in Hong Kong, uploaded on 8 October 2025, in the section headed documents required for an application. The dossier rules that give the list operational meaning sit in GN-02 for Class II, III and IV general medical devices and in GN-06 for Class B, C and D in vitro diagnostic devices. The validity and verification rules were updated in GN-01 on 1 September 2026.

Two features of the legal basis matter in practice. The list is a floor rather than a ceiling, because the guidance notes add requirements that the one-page overview compresses. And the validity rules are written in the overview note rather than in the route-specific notes, which means they apply to every certificate in the file regardless of which route the applicant takes.

3. Expert insights

The list is dual-track, and only one track applies. A CAB certification review certificate is confined to Route 1. Marketing approval documents from a reference jurisdiction are confined to Route 2. Preparing both sets is wasted effort, and the eligibility self-assessment should be completed before dossier drafting rather than after. An applicant who assembles a CAB file while holding a usable reference approval has spent months on evidence that MDD will not read.

The revision of 1 September 2026 changed the form of what is filed, not the list. Paragraphs 5.6.2–5.6.3 of GN-01 state that a certificate must be valid at the time of submission, that a certificate expiring during review must be replaced on request, and that an electronic certificate is sufficient where it carries a valid and verifiable electronic signature of an authorised person and its authenticity can be checked on the official website designated by the issuing body. MDD may also require a certified copy, check the qualifications of the person certifying, or verify directly with the issuer. The practical consequence is that a certificate is now a live document with a monitoring obligation attached, not a scanned attachment collected once.

Other technical documentation is the residual clause and the most common source of requests for further information. This item has no fixed contents and depends on the risk class and technical characteristics of the product. Software is examined against TR-007, artificial intelligence against TR-008, personalised devices against TR-009 and combination products against TR-010. Treating the residual item as an empty box is the single most reliable way to invite a supplementary request late in the review.

A local licence is a parallel obligation, not a substitute. A device involving radiation needs a licence under Chapter 303 in addition to listing. The two obligations run side by side, and obtaining a listing does not waive the licence requirement. Applicants who discover the licence obligation only after listing begins face the licensing work under time pressure, with the product already positioned for the market.

The list rewards sequence discipline. Administrative items can be closed in days, certificate items take weeks, and technical documentation takes months. Building the file in the order the list is printed inverts that reality and pushes the slowest work to the end of the programme, where there is no schedule left to absorb it.

4. Practical recommendations

• Use the list as a gate. Turn the 12 categories into a project gate table and do not release the submission while any item is open.
• Keep one expiry register. Manage the expiry dates of ISO 13485 certificates, CAB certificates, reference approvals and quality system certificates in a single register, and replace proactively anything that will expire during review.
• Self-check electronic documents in advance. Confirm that each electronic signature is valid and verifiable, and keep a note of the official verification entry point of the issuing body.
• Split technical documentation by TR number. Assemble software, artificial intelligence, personalised devices and combination products into separate volumes keyed to the corresponding technical reference file.
• Screen licensing early. Screen every product for radiation or other local licensing exposure before, not after, the listing file is built.

5. Verification checklist

• □ The manufacturer’s letter appointing the local responsible person is prepared and signed.
• □ The applicant’s Hong Kong, China business registration certificate is valid.
• □ The CAB certificate or the reference approval has been prepared according to the chosen route.
• □ The ISO 13485 certificate or equivalent evidence is valid and its scope covers the product applied for.
• □ The Essential Principles checklist or declaration has been completed.
• □ The clinical evaluation report or performance evaluation report has been prepared.
• □ Labels, instructions for use and manuals have been prepared in line with TR-005.
• □ The need for a local licence, including under Chapter 303, has been confirmed.
• □ All certificates are valid and verifiable on the submission date.
• □ The MDIS account is open and the electronic submission has been completed.

Regulatory information verified as at 29 October 2026. The legislation, guidance and effective dates described in this article are limited to the content published by the official sources listed under legal basis on that date; where those sources are updated, the latest published version prevails.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for Hong Kong, China. Our team prepares MDACS-compliant dossiers, coordinates evidence of reference approvals and ISO 13485 certificates, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com