Classification Determination: Two Routes and the 20-Working-Day Decision

1. Key takeaways

Where a product is not listed in the Medical Device Classification Catalogue, Article 23 of the Regulations offers two parallel routes, and the applicant chooses between them.

• Route A, direct Class III registration: skip the class determination and file a Class III application with the National Medical Products Administration (NMPA).
• Route B, class confirmation: assess the class under the classification rules and apply to the NMPA, which must determine and notify the class within 20 working days of acceptance.

The choice is about timing.

The GRZAN view. The test is not which route is faster but how likely the product is to fall into Class II. A mature mechanism equivalent to a marketed Class II device earns more from Route B, while a novel mechanism without comparators saves a round trip under Route A. Record the rationale at kick-off.

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, structural characteristics and method of use, and gives the NMPA power to issue and adjust the rules and catalogue. Article 23(1) allows an applicant for a newly developed device not yet listed to apply directly for Class III registration or to assess the class under the rules and apply for confirmation; Article 23(2) requires the NMPA to determine and notify the class within 20 working days of acceptance. 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 85 penalises false information in a filing.

Departmental rules. SAMR Order No. 47, promulgated 26 August 2021, effective 1 October 2021: Article 8 sets the filing and certification levels; Article 14(1) requires the applicant to be an enterprise or research institution able to bear liability, and Article 14(2) requires an overseas applicant to appoint a Chinese agent; Article 20 requires registration and filing to follow the rules and catalogue; Article 22 allows consultation before acceptance; Article 23 establishes expert consultation, expressly covering classification; Article 120 defers fees to State Council rules.

Normative documents. The Working Procedure for Dynamic Adjustment of the Classification Catalogue, NMPA Announcement No. 60 of 2021, published 8 May 2021, allows adjustments to be started by the NMPA or proposed by enterprises and industry bodies. Announcement No. 63 of 2025, issued 27 June 2025, improves classification and naming principles and optimises determinations for robots, high-end imaging, artificial intelligence devices and new biomaterials. Announcement No. 121 of 2021 sets submission and certificate formats. Fees are CNY 153,600 initial, CNY 50,400 variation and CNY 40,800 renewal for domestic Class III, CNY 210,900 and CNY 308,800 for import Class II and Class III initial registration, and CNY 43,200 for a high-risk trial application. Since 2020 the NMPA has published 123 adjustments in four batches, per the 2025 annual registration work report of 24 February 2026.

Practical estimate. Class II fees follow provincial pricing and finance rules; the CNY 40,670 per registration unit figure appears in some provinces and must be verified locally. The fee for a class confirmation itself should also be confirmed with the receiving authority before filing.

3. Expert insights

The two routes are parallel, not sequential. Article 23(1) uses two permissive clauses, so confirmation is not a mandatory precursor and a determination is not a legal precondition. Its value is converting the class into a fixed variable that settles authority, file depth, fee and clinical route at once.

The 20 working days cover the determination only. Preparation, acceptance review and the later registration file sit outside the clock, so confirmation adds a front-end period measured in months and belongs on a separate line of the launch plan. Run technical requirements and non-clinical studies in parallel so only differences remain.

Eligibility requires novelty and absence from the catalogue. Article 23(1) covers newly developed devices not yet listed, so a routine model of a mature product does not qualify, and a listed product follows Article 20 of Order No. 47. With 123 adjustments since 2020, products once uncovered may now be listed. Where an entry does not fit, the right move is a catalogue adjustment proposal under Announcement No. 60 of 2021.

Route A carries a sunk cost that limits its use. Filing directly means paying CNY 153,600 domestic or CNY 308,800 import for Class III, and if review treats the device as Class II neither the fee nor the deeper clinical package is recoverable. Route A pays off where Class III is likely, time value exceeds the fee gap and the Class III package is nearly complete; two of the three should hold.

A determination resets five downstream items. Authority, review body, fee, clinical depth and production qualification move together, though both classes need a production licence under Article 4 of Order No. 53.

Three instruments reduce uncertainty before filing. The communication mechanism under Article 22 allows pre-acceptance consultation, expert consultation under Article 23 covers classification, and a catalogue adjustment proposal under Announcement No. 60 of 2021 changes the rule rather than one class, which suits platform technologies.

4. Practical recommendations

• Recheck the catalogue before acceptance. With 123 adjustments in four batches, stale search results lead to refusal.
• Organise the file around the three factors. Argue intended purpose, structure and method of use separately and attach a comparison with a listed equivalent.
• Check applicant eligibility first. The applicant must be an enterprise or research institution able to bear liability, and an overseas applicant needs a Chinese agent.
• Record the route decision in writing. Capture the probability estimate, fee gap and time value, since switching mid-way means requeueing.
• Run confirmation and file preparation in parallel. Prepare technical requirements, non-clinical studies and draft labels to the higher standard.
• Log the determination. Record the date, class and rule applied as evidence of the classification duty.
• Assess innovation channels at the same time. Announcement No. 63 of 2025 supports classification optimisation for robots, imaging, artificial intelligence and biomaterials.
• Rebuild the budget after the determination. Class II follows the provincial standard, Class III CNY 153,600 domestic or CNY 308,800 import; do not lock the budget before the class is fixed.

5. Verification checklist

• □ Product qualifies as newly developed and unlisted under Article 23(1).
• □ Current catalogue version checked against the 123 adjustments.
• □ Route comparison documented, including the probability of Class II.
• □ Applicant eligibility confirmed, with a Chinese agent where overseas.
• □ File organised around intended purpose, structure and method of use.
• □ Comparison with listed equivalent devices retained.
• □ 20 working days determination period built into the schedule.
• □ Authority, review body, fee and clinical route recalculated after the determination.
• □ Class III fee budgeted at CNY 153,600 domestic or CNY 308,800 import.
• □ Class II fee standard verified with the provincial authorities.
• □ Non-clinical work and technical requirements progressed in parallel.
• □ Determination date, class and legal basis logged.

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