Classification Rules and Catalogue: How Class Determines the Registration Route

1. Key takeaways

The management class is not a product label but a pathway selector. Once fixed, it locks the authority, file depth, clinical route, production qualification and fee.

Three consequences follow.

• Authority: domestic Class II goes to the province, domestic Class III and all import routes to the NMPA.
• Fees: domestic Class III initial registration is CNY 153,600; Class II fees are set provincially, with CNY 40,670 per registration unit visible in some provinces as a practical estimate; Class I filing carries no fee.
• Clinical depth: the higher the class, the lower the chance of exemption, and a high-risk Class III device needs trial approval within 60 working days, deemed granted without notice.

The catalogue is dynamic. Since 2020 the NMPA has published 123 catalogue adjustments in four batches, according to the 2025 annual registration work report issued on 24 February 2026.

The GRZAN view. A wrong class is the costliest and most easily dismissed error. It does not surface in deficiency review but explodes when the file is rejected at the wrong window, the fee is recalculated or the clinical route collapses. Classification belongs first on the kick-off agenda.

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 defines Class I as low risk, Class II as moderate risk requiring strict control and Class III as higher risk requiring special measures, and limits the assessment factors to intended purpose, structural characteristics and method of use, with the NMPA issuing and adjusting the rules and catalogue. Article 13 makes Class I a filing and Classes II and III registrations; Article 15(1) assigns domestic Class I filing to the municipal authority; Article 16(1) assigns domestic Class II to the province and Class III to the NMPA; Article 22 sets 5-year certificate validity; Article 32 requires a production licence for Classes II and III, decided within 20 working days and valid 5 years.

Departmental rules. SAMR Order No. 47, promulgated 26 August 2021, effective 1 October 2021: Article 8 sets the filing and certification levels; Article 20 requires registration and filing to follow the rules and catalogue, with a class confirmation under Article 23 of the Regulations where a product is not covered; Article 120 defers fees to State Council rules; Article 123 applies the import rules to Hong Kong, Macao and Taiwan devices. SAMR Order No. 53, on production, promulgated 10 March 2022, effective 1 May 2022, requires licences for Classes II and III and filing for Class I (Article 4), and an on-site inspection within 3 months of Class I production filing (Article 22).

The wording of the regulation becomes concrete obligations downstream.

Normative documents. The Working Procedure for Dynamic Adjustment of the Classification Catalogue, NMPA Announcement No. 60 of 2021, published 8 May 2021, allows adjustments started by the NMPA or proposed by enterprises and industry bodies. Announcement No. 22 of 2023 on the third UDI batch covers 103 Class II device types in 15 categories, defined down to the second-level product category in the catalogue. The 2025 clinical evaluation exemption catalogue, Notice No. 19 of 2025, published 12 May 2025, covers 1,047 products with 28 additions.

Practical estimate. Class II fees are set by provincial pricing and finance departments and vary; the CNY 40,670 per registration unit figure seen in some provinces must be verified with the provincial authorities at project initiation.

3. Expert insights

Risk is the substance, and only three factors count. Intended purpose, structural characteristics and method of use decide the class; claims, revenue and technical sophistication do not. Two models from one line can fall into different classes when purpose or use differs, as with one material used for surface cleansing and for wound coverage.

The catalogue moves in both directions. Since 2020, 123 adjustments have been published in four batches. A class is not fixed for life: check the version at kick-off and before acceptance, and where a marketed product moves up, re-file and update the licence, instructions and label. Where Class III moves down to Class II, the certificate stays valid but renewal goes to the new authority at a new fee.

A wrong class produces three different bills. Under-classification is a compliance risk at inspection, over-classification a cost risk that review never corrects, and a wrong authority a procedural risk that resets the timetable.

Being in the catalogue is not the end of the determination. Article 20 of Order No. 47 requires registration and filing to follow the rules and catalogue, but a catalogue entry is a description and an example. Alignment needs consistency in structure, in purpose and scope, and in use form. The third is the usual failure: sterile and non-sterile versions often sit in different entries and may carry different classes.

Classification triggers three downstream rules at once. UDI follows the entry, with the third batch covering 103 Class II types in 15 categories; the clinical route is anchored to the same entry and the 2025 exemption catalogue of 1,047 products; production qualification follows the class. Output a four-column table linking class, UDI, clinical evaluation and qualification.

4. Practical recommendations

• Put classification first on the kick-off agenda. Record the entry number, version and rule applied, traceable to specific text.
• Keep a catalogue version log. Record each check date and version, so the file can answer which version applied at kick-off.
• Use class confirmation for unlisted products. Under Article 23 a determination is issued within 20 working days; a direct Class III filing that is later downgraded wastes the Class III file.
• Judge sterile and non-sterile, single-use and reusable separately. These differences usually map to different entries and pre-empt a registration unit split later.
• Cost by class and authority. Domestic Class III is CNY 153,600 initial, CNY 50,400 variation and CNY 40,800 renewal; import Class II and III initial fees are CNY 210,900 and CNY 308,800.
• Monitor class changes after launch. An upward move requires re-filing or re-registration with matching updates to the licence, instructions and label.
• Apply the rules rather than analogy. Where the catalogue is silent, the classification rules govern, and comparison with a marketed product is supporting evidence only.

5. Verification checklist

• □ Product checked against the current catalogue, with entry number and version recorded.
• □ Intended purpose, structural characteristics and method of use documented.
• □ Written class conclusion stating whether it follows an entry or the rules.
• □ Class confirmation obtained for unlisted products, or a direct Class III route decided.
• □ Sterile and non-sterile, single-use and reusable versions judged separately.
• □ Receiving authority confirmed by class and by domestic or import status.
• □ Production qualification matched, filing for Class I and licence for Classes II and III.
• □ Fees calculated by class, with the provincial standard verified for Class II.
• □ UDI applicability determined against the third batch scope.
• □ Clinical evaluation route matched to the 2025 exemption catalogue.
• □ Monitoring of catalogue changes established for marketed products.
• □ Classification conclusion carried into registration unit division and technical requirements.

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 typetesting at qualified testing institutes, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com