Class I Filing: Complete on Submission, With Undiminished Compliance Duties

1. Key takeaways

Class I devices are subject to product filing, the lightest market-entry route in China, but the duty list is not shortened by it.

• Product filing. A domestic filing goes to the municipal drug administration of the districted city where the filer sits, complete on submission (Article 15(1), Regulations on Supervision and Administration of Medical Devices).
• Imported filing. An overseas filer appoints a Chinese legal person to file with the NMPA, with proof of marketing abroad (Article 15(2)).
• Production filing. Class I manufacture needs a production filing, and the authority inspects within 3 months (Article 22, Order No. 53).
• Duties unchanged. A filer carries lifecycle responsibility (Article 13) and the five Article 20(1) duties.
• Consequences explicit. False filing data falls under Article 85; failure to file draws an order to correct and, if uncorrected, a fine of CNY 10,000 to 30,000 (Article 107).

The GRZAN view. The usual attitude is that the threshold is low, so anything will do; the usual failure is filing content that does not match the product. No technical review stands at the gate, so responsibility for truth rests on the filer, and the inspection within 3 months of the production filing is where the system checks it.

2. Legal basis

Administrative regulation. State Council Order No. 739 (9 February 2021; effective 1 June 2021): Article 6 (Class I is low risk, routine management suffices), 13 (Class I filed, Classes II and III registered; lifecycle quality management and legal responsibility for safety and effectiveness), 15(1) (domestic filing with the municipal authority, complete on submission), 15(2) (overseas filer appoints a Chinese enterprise legal person to file with the NMPA, with proof of marketing abroad, waived for innovative devices not marketed overseas), 20(1) (five duties: quality system; post-market research and risk control; adverse event monitoring and re-evaluation; traceability and recall; other NMPA duties), 22(1) (certificate valid 5 years), 39 (instructions and labels), 85 (false filing data).

Departmental rules. SAMR Order No. 47 (26 August 2021; effective 1 October 2021): Article 8 (authority for each filing route), 14(1) (enterprise or research institution able to bear liability), 14(2) (Chinese agent assisting the Article 20(1) duties), 15 (quality system), 19 (mandatory standards, with a non-applicability statement), 26 (objectively judgeable indicators and methods), 27 (instructions and labels), 30 (testing first), 107 (order to correct, then CNY 10,000 to 30,000), 120 (fees). SAMR Order No. 53 (10 March 2022; effective 1 May 2022): Article 4 (production filing for Class I), 22 (inspection within 3 months). Former CFDA Order No. 6 (30 July 2014; effective 1 October 2014): Articles 2, 4, 7, 8 and 9 (instructions and labels required, content consistent with the filing, leaflet with the smallest sales unit, generic name, Chinese prevailing).

Normative documents. Announcement No. 121 of 2021 (29 September 2021; effective 1 January 2022) sets submission requirements and approval formats; No. 60 of 2021 (8 May 2021) governs dynamic catalogue adjustment, which has published 123 entries in four batches since 2020; the UDI System Rules of 2019 require upload before marketing (Article 15); No. 46 of 2025 (28 April 2025; effective 1 October 2025) sets online sales rules.

Practical estimate. Municipal platforms publish the exact filing items, and some localities add the full technical requirements, a test report and a draft leaflet. Check the local list and e-submission rules, not another region’s template.

3. Expert insights

Filing on submission moves review to the back end. Article 15(1) is often read as no review; none occurs, and no approval document issues. Three checks replace it: the inspection within 3 months of the production filing, post-market supervision confirming the filing matches the product, and enforcement under Article 85 or 107. All three ask if the filing is true.

Filer and registrant share one duty list. Article 20(1) names both.

Class I skips only renewal: a filing never expires, while a certificate runs 5 years (Article 22(1)). Entry is simplified for low risk; lifecycle duties stay because low risk is not no risk.

The 3-month inspection is the only fixed external check. Article 22 of Order No. 53 sets the only time-bound external review in the chain. Inspectors test whether the production filing matches actual conditions, whether a quality system runs, and whether the firm can test its requirements. The third is overlooked most: filing the requirements promises the product meets them, and the inspection asks whether test capability and release procedures exist. Requirements the firm cannot test survive the filing and surface at the inspection; GRZAN prepares production in parallel, not after it.

Class can change, and with it the duty set. The catalogue has published 123 entries in four batches since 2020 (Announcement No. 60 of 2021). Where a Class I device is raised to Class II:

A raised device must be handled under the new class within the set period, so filers still need catalogue monitoring.

Imported filing differs in three places. The authority moves up to the NMPA (Article 15(2) of the Regulation; Article 8 of Order No. 47), not the municipal body. Proof of marketing abroad is required, waived only for innovative devices not marketed overseas. An agent is mandatory, assisting the Article 20(1) duties (Article 14(2) of Order No. 47). The first is missed most: domestic-pattern material sent to a municipal authority is returned.

Instructions and labels meet the registered-device standard. A Class I device skips registration but not Articles 2, 4, 7, 8 and 9 of Order No. 6. The consistency clause in Article 4 points at the filing itself, so inconsistency is evidence the filing is untrue, triggering both filing and labelling problems.

4. Practical recommendations

• Prepare to registration standard. Every indicator should be supportable and match later inspection conditions.
• Run product and production filing in parallel. The 3-month clock starts at the production filing.
• Test the requirements before filing them. Never write an indicator the firm cannot verify or release.
• Check eligibility. The filer must be an enterprise or research institution (Article 14(1)); an overseas filer needs a Chinese agent (Article 14(2)).
• Align filing, instructions and label before submission. A later leaflet change creates inconsistency with the filing.
• Update the filing when details change. Failure draws a CNY 10,000 to 30,000 fine (Article 107).
• Monitor the catalogue. With 123 entries in four batches since 2020, a raised class means a fresh process.
• Run post-market duties as usual. Research, adverse events, traceability, recall and UDI upload apply.

5. Verification checklist

• □ Class I confirmed with a catalogue entry.
• □ Filer eligible as an enterprise or research institution.
• □ Domestic authority confirmed as municipal (Article 15(1)).
• □ Imported devices filed with the NMPA, agent appointed (Articles 15(2), 14(2)).
• □ Proof of marketing abroad, or the innovation waiver.
• □ Mandatory standards listed; exclusions filed (Article 19).
• □ Indicators objectively judgeable, methods stated (Article 26).
• □ Testing completed before filing (Article 30).
• □ Production filing made; conditions ready for the 3-month inspection (Article 22, Order No. 53).
• □ Instructions and labels scientific, true and consistent with the filing (Article 4).
• □ Leaflet with the smallest sales unit, generic name, Chinese wording (Articles 7-9).
• □ Change-filing mechanism in place; CNY 10,000 to 30,000 risk noted.
• □ Catalogue monitoring for a raised class.
• □ Post-market duties in place, including UDI data.

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