General Naming Rules: How Naming Defects Slow Device Registration

1. Key takeaways

The generic name is the primary key of a device across the regulatory chain: an entry on the registration certificate, a mandatory item in the instructions and on the label, and a declared field in the Unique Device Identification (UDI) database.

• Legal duty. Instructions and labels must use the generic name, and for Classes II and III the product name must match the certificate (Article 8, Provisions on the Administration of Medical Device Instructions and Labels).
• Consistency perimeter. The name must agree across the technical requirements, instructions, label, certificate, manufacturing documents and UDI database record.
• Guidelines by category. The NMPA issues naming guidelines per category, and Announcement No. 63 of 2025 commits to better classification and naming principles for medical robots, high-end imaging, artificial intelligence and new biomaterials.

A naming error costs differently: a documentation gap surfaces at correction, a name problem spreads along the chain.

The GRZAN view. Freeze the name at initiation, with the technical requirements and before samples go to test. Our rule: no name frozen, no sample submitted. It sounds severe, but removes the cost in the last three rows.

2. Legal basis

Administrative regulation. Regulations on Supervision and Administration of Medical Devices, State Council Order No. 739, promulgated 9 February 2021, effective 1 June 2021. Article 6 requires risk assessment against intended purpose, structure and use; Article 39 requires instructions and labels to meet the Regulation and the Provisions.

Departmental rules. SAMR Order No. 47, promulgated 26 August 2021, effective 1 October 2021: Article 20 (registration and filing follow the classification rules and catalogue), 26 (technical requirements drafted to the NMPA guideline with objectively judgeable indicators and methods), 27 (the Provisions govern instructions and labels), 30 (testing before a trial or application), 79 (variation where a certificate entry changes). Former CFDA Order No. 6, promulgated 30 July 2014, effective 1 October 2014: Article 2 (instructions and labels on devices sold or used in China), 4 (content scientific, true, complete, accurate and consistent with the registration), 7 (leaflet with the smallest sales unit), 8 (generic name; Classes II and III matching the certificate), 9 (Chinese wording, other languages permitted but Chinese prevailing), 10(2) and 13(2) (agent name, domicile and contacts on imports), 14 (bans on comprehensive promises such as safe, non-toxic, refund if ineffective, no dependence or insured, absolute efficacy terms, cure or effective rates and awards, comparison with other products, and other prohibited content), 16 (no unauthorised change to reviewed instructions).

Normative documents. Announcement No. 63 of 2025, issued 27 June 2025, proposes the naming improvements for robots, high-end imaging, artificial intelligence and biomaterials. Announcement No. 121 of 2021, published 29 September 2021, effective 1 January 2022, sets submission requirements and approval formats. The UDI System Rules of 2019 require, in Article 15, upload of the device identifier and related data before marketing. Announcement No. 22 of 2023 sets the third batch at 15 categories and 103 Class II varieties.

Practical estimate. Name composition and characteristic terms follow the NMPA category guideline, whose catalogues differ by category; without one, the general principles apply. Search first; where none is found, confirm through the Article 22 channel before acceptance rather than renaming later.

3. Expert insights

One name, six carriers. Article 8 of Order No. 6 has two limbs: use the generic name, and for Classes II and III match the certificate. Six carriers must then agree: technical requirements, test report, certificate, instructions, label and outer packaging, UDI database record.

The sixth is usually missed: once the identifier is uploaded, as Article 15 requires before marketing, correction starts in the database, a separate system, and the file can end with A on the certificate, B on the label, C in the database.

Four defects, four stages.

Exaggerated wording also conflicts with Article 14, so compliant body text does not save a non-compliant name. Drift is heaviest: the classification decision can be overturned, and class and accepting authority recalculated.

Generic name versus trade name.

Put brand resources into the trade name and keep the generic name merely compliant; differentiating inside the generic name only adds variation cost. The trade name cannot carry efficacy claims either, since Article 14 reaches its wording.

The freeze point sets the scale of rework.

Article 41 of Order No. 47 requires all defects notified at once and the supplement supplied within one year, failing which review terminates and the application is refused. Spending that one opportunity on a rename is the poorest trade available.

Naming, classification and UDI move together. A name matching a catalogue entry is easier to locate, while drift forces re-determination; the third UDI batch reaches 15 categories and 103 Class II varieties, defined down to the level-2 category, where locating the entry depends on the name; and the categories in Announcement No. 63 of 2025 are still being refined, so search current documents. GRZAN builds one name, catalogue entry and UDI applicability table at initiation.

Imported names cross two conversions. Language first: Article 9 requires Chinese, other languages permitted but Chinese prevailing. System second: a foreign name follows home rules and may not fit Chinese characteristic-term selection, and translation tends to produce stacked terms or a model number inside it. Derive the foreign wording from the Chinese, not the reverse, and check agent details under Articles 10 and 13 in the same pass.

4. Practical recommendations

• No name frozen, no sample submitted. Renaming before testing is the cheapest correction.
• Search the category guideline first. Where none exists, confirm through the Article 22 communication channel.
• Keep model, specification and brand out of the name. Or a model series cannot share one generic name.
• Avoid modifiers. High-efficiency, intelligent, precise or next-generation wording triggers both the naming rules and Article 14.
• Put differentiation in the trade name. The generic name serves compliance; the trademark carries brand expression.
• Run a three-source check after certification. Certificate, label and packaging, and UDI record must match before first release.
• Treat a rename as a variation. The product name is a certificate entry, so a change is an approval under Article 79, not a document edit.
• Name imported devices Chinese first. Fix the Chinese name, then derive the foreign wording (Article 9).

5. Verification checklist

• □ Chinese generic name fixed before testing.
• □ Naming guideline searched, with terms justified.
• □ No model, specification or brand mark inside the name.
• □ No modifiers such as high-efficiency, intelligent or precise.
• □ Name corresponds to a catalogue entry.
• □ Name in the requirements, instructions and label matches the certificate (Article 8).
• □ Chinese wording used, other languages permitted but Chinese prevailing (Article 9).
• □ Agent name, domicile and contacts on imported devices (Articles 10 and 13).
• □ No content prohibited by Article 14.
• □ Reviewed instructions not altered (Article 16).
• □ UDI database name matches the certificate and label (Article 15).
• □ Third-batch UDI applicability determined (15 categories, 103 Class II varieties).
• □ Three-source check completed after certification.
• □ Any rename handled as a variation (Article 79).

Verified as at 29 October 2026 against NMPA, SAMR and State Council publications; practical estimates have no legal effect.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Chinese market. Our team manages National Medical Products Administration (NMPA) registrations, coordinates type testing at qualified testing institutes, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com