Asian Medical Device Nomenclature (AMDN) and naming consistency

1. Key takeaways

Under MDACS, Hong Kong, China uses the Asian Medical Device Nomenclature (AMDN) as its device naming system, and the relevant examples and nomenclature materials are published on the MDD website. Naming is not a formality. It appears in the listing application, on the listing certificate and in the public list, and together with the model and the intended purpose it forms the identity of the device. If any one of the three is inconsistent with the others, a supplementary explanation is requested or the file is returned for further information.

Because the same name has to survive three appearances, naming decisions taken late in the process tend to create contradictions that are expensive to unwind. The naming choice belongs at the beginning of the project, in the same session as the classification decision.

• Nomenclature is part of identity. Name, model and intended purpose travel together through application, certificate and public list.
• AMDN is a regional instrument. Its category logic is closer to Asian naming systems than to European or North American ones.
• Naming and classification interact. The nomenclature category often correlates with the risk class, so the two decisions should be made together.
• The public list exposes errors. Information on listed devices is published and searchable, so an implausible name is visible to buyers as well as reviewers.
• Families need a clear hierarchy. Where one family contains several models, the relationship between device name and model has to be stated explicitly.

2. Legal basis

The nomenclature requirement is carried by the MDACS pages on the Asian Medical Device Nomenclature rather than by an ordinance, which is consistent with the administrative character of the system. GN-00 supplies the definitions and abbreviations used across the guidance notes, including the naming terms. GN-02 sets the device description and naming requirements within a listing application. MDD announced the adoption of the Asian medical device nomenclature through its news page on 19 June 2009, and the overview of the listing process, uploaded on 8 October 2025, sets out the application information requirements in which the name appears.

The age of the adoption announcement is instructive. The nomenclature has been part of the system for well over a decade, which means there is an accumulated body of listed products whose names can be consulted as precedent. That body of precedent is the most reliable guide to what a reviewer in a given category expects to see.

3. Expert insights

AMDN is a product of regional harmonisation, not a Hong Kong, China invention. The Asian Medical Device Nomenclature is intended for coordinated use across the region, and its classification logic has affinities with the naming systems used in markets such as the Chinese mainland, Japan and Korea. That brings a practical advantage: manufacturers from the Chinese mainland usually find it easier to align on nomenclature terms than manufacturers from Europe or North America, a practical estimate rather than a documented rule.

Naming and classification influence each other. The nomenclature places a device into a particular category, and the category is often correlated with the risk class. A mistaken naming choice can therefore drag the classification decision with it. Naming and classification should be completed in one step rather than sequentially, ideally recorded on the same assessment form so that the reasoning behind both is visible together.

The public list makes naming errors hard to hide. Information on listed medical devices is published on the MDD website as a public list, and procurement staff can search it directly. A name that does not plausibly describe the product affects the review, and it can also raise a compliance question from a buyer who has checked the list before placing an order. The reputational cost outlasts the review.

Multi-model products need a clear naming hierarchy. Where a product family contains several models, the relationship between the device name and the model has to be explicit, so that models are not written into the device name and the public list does not become cluttered with variants that read as separate devices.

Precedent reduces friction. Where a product of the same category has already been listed, adopting the same nomenclature term lowers review resistance, because the reviewer has already accepted that term in a comparable file. Departing from established usage requires a reason that the file should state.

4. Practical recommendations

• Decide naming and classification together. Fix the AMDN category first, then classify under TR-003 or TR-006, and record both on the same determination form.
• Build a name and model cross-reference table. Place the table on the first page of the dossier and use the same wording throughout.
• Check the three appearances. The device name must be identical in the application form, the label and the instructions for use.
• Follow existing listed names. Where a comparable product has already been listed, prefer the same nomenclature term to reduce review friction.
• Verify the nomenclature version. Confirm that the category used corresponds to what MDD currently publishes rather than to an older reference copy.

5. Verification checklist

• □ The device nomenclature category has been determined in accordance with AMDN.
• □ Naming and classification were determined on the same assessment form.
• □ A name and model cross-reference table has been established.
• □ The name is identical in the application form, the label and the instructions for use.
• □ Existing names used for comparable products in the MDD public list have been checked.
• □ The nomenclature version used matches what MDD currently publishes.

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