How China medical device registration works with NMPA approval
China medical device registration starts with the risk class. Class I is filed; Class II and III need registration. See dossier, agent and review rules.
How China medical device registration and NMPA approval work
China medical device registration depends on risk class: Class I devices are filed, and Class II and III need a registration certificate. For an imported device, the National Medical Products Administration (NMPA) handles the filing or the registration, and the overseas manufacturer must appoint a Chinese enterprise legal person as its agent (Order 47, Articles 8 and 14).
China medical device regulations
The main texts are State Council Decree No. 739, effective 1 June 2021, and State Administration for Market Regulation (SAMR) Order No. 47, effective 1 October 2021. Decree No. 797 amended Decree 739 from 20 January 2025 without changing the registration rules (Decree 739; amendment; Order 47).
In vitro diagnostic (IVD) reagents follow SAMR Order No. 48, not Order 47. They use separate classification rules and sit outside the general device catalogue (Order 48; classification rules; catalogue).
China medical device classification
Decree 739 Article 6 defines Class I as low risk, Class II as moderate risk and Class III as higher risk. Routine management is enough for Class I. Class II needs strict control, and Class III needs special measures as well (SAMR).
Start with the Medical Device Classification Catalogue, implemented on 1 August 2018, then check later adjustments. NMPA Announcement 2025 No. 132 adjusted 31 categories. NMPA Announcement 2026 No. 52 sets the registration and filing rules after a class change: new applications follow the new class, and transition periods apply (catalogue; category adjustments; transition rules). Check NMPA's latest announcements before relying on an older class.
The Classification Rules judge class from intended purpose, structure, form of use, state of use and body contact. The highest applicable class wins. Devices supplied sterile are at least Class II. So are devices with a measuring function. Absorbable devices are Class III (classification rules, Articles 4 and 6).
For a new device outside the catalogue, apply directly as Class III or seek a classification determination first. Determination requests go through the National Institute for Food and Drug Control's online system (Order 47, Article 64; Beijing MPA guidance).
Who handles NMPA approval
NMPA is the national regulatory authority for imported devices and for domestic Class III registration. Local drug regulators handle the other domestic routes (Order 47, Article 8).
| Device | Domestic manufacturer | Imported device |
|---|---|---|
| Class I | City-level regulator: filing | NMPA: filing |
| Class II | Provincial regulator: registration | NMPA: registration |
| Class III | NMPA: registration | NMPA: registration |
Imported Class II devices go to NMPA, not a provincial office.
Class I filing is complete when the full filing materials are submitted. The authority publishes the filing information within 5 working days (Decree 739, Article 15).
What foreign manufacturers need
Appoint a Chinese enterprise legal person as your agent. It handles the registration or filing, and it assists with your legal duties: the quality system, post-market risk control, adverse-event monitoring, traceability and recalls (Order 47, Article 14; Decree 739, Article 20).
Provide proof of marketing approval from the authority of the applicant's registration country or the manufacturing country. If that country doesn't regulate the product as a device, provide documents showing it may be marketed there. Innovative devices not yet marketed abroad are exempt (Order 47, Article 18).
Prepare the registration dossier
For Class II and III, the dossier includes risk analysis, product technical requirements, a test report and clinical evaluation data. It also includes draft instructions and labels, quality management system documents for development and production, and other evidence of safety and effectiveness (Order 47, Article 52).
The applicant writes the technical requirements: performance and safety indicators of the finished device that can be objectively assessed, plus the test methods. The test report may be a self-test report or one from a qualified testing institution (Order 47, Articles 26 and 32).
Use the submission format in NMPA Announcement 2021 No. 121. It took effect on 1 January 2022 and replaced the 2014 format. The modules are administrative documents, regulatory information, a summary, non-clinical data, clinical evaluation, labelling drafts and quality system documents (announcement; Beijing MPA dossier guidance).
When clinical evaluation is required
For devices under Order 47, clinical evaluation is required for registration and for filing, unless the device is exempt. Evaluation may use a clinical trial or an analysis of clinical data on a same-variety device (Order 47, Articles 33-35). Check the exemption catalogue in NMPA Notice 2025 No. 19, and any later update (catalogue).
Trials of higher-risk Class III devices need prior NMPA approval. The decision is due within 60 working days of acceptance. No decision in that period counts as consent (Decree 739, Article 27).
Review timelines and certificate validity
Review periods are counted in working days. Technical review takes 60 for Class II and 90 for Class III. You have 1 year to supply requested supplementary information, and the review after it takes another 60. Formal gaps are notified within 5, the decision is due within 20 of the review opinion, and the certificate is issued within 10 (Order 47, Article 92).
Real elapsed time is longer than these limits. Your time supplementing materials, testing, inspections and expert consultation do not count toward them (Order 47, Article 92).
Certificates last 5 years. Apply for renewal to the original authority at least 6 months before expiry. And if no decision is made before expiry, the renewal is treated as granted (Decree 739, Article 22; Order 47, Articles 58 and 82).
A substantial change to design, raw materials, the production process, or the scope or method of use needs change registration when it may affect safety or effectiveness. Other changes are filed within 30 days (Decree 739, Article 21; Order 47, Article 79).
Faster routes
Order 47 offers an innovative procedure for devices whose core technology has a Chinese invention patent, whose working mechanism is first in China with significant clinical value, and whose design is essentially finalised (Order 47, Article 68). A priority procedure covers devices for rare diseases, cancer, the elderly or children, and urgent clinical needs with no similar approved device (Order 47, Article 73).
After approval
Adverse event monitoring follows SAMR/NHC Order No. 1, in force since 1 January 2019 (Order No. 1). For an imported device, the agent reports adverse events (Order No. 1, Article 3). Production must meet the revised medical device GMP, NMPA Announcement 2025 No. 107, in force from 1 November 2026. It repeals CFDA 2014 No. 64 (GMP).
UDI already covers every Class III device, including IVDs, and 103 Class II types. From 1 June 2027 it also covers all Class II devices, including IVDs, and all Class I IVDs made from that date. From 1 June 2029 it covers all Class I devices made from that date (NMPA UDI announcement).
You can ask RegAffairs AI how to register a medical device in China and open the cited regulatory texts behind its answers.