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Class I Filing (备案)

Class I medical devices — those presenting the lowest risk — enter the Chinese market through a filing (备案) process rather than registration. Filing is administered by district/county-level market supervision and administration bureaux (市场监督管理局) for domestic manufacturers, and by national NMPA for imported Class I devices.

Filing dossier requirements​

The filing package for a Class I device typically includes:

  1. Filing application form (completed through the NMPA online system)
  2. Product technical requirements (产品技术要求) — specifications including performance, testing methods, and labelling
  3. Product description — intended use, principle of operation, components, materials
  4. Risk analysis summary
  5. Proof of manufacturer's production filing (for domestic manufacturers)
  6. Sample label(s) and instructions for use (IFU) draft
  7. China Agent authorisation letter (if imported)

Process​

  1. Manufacturer (or China Agent for imports) submits the dossier online via the NMPA online service platform
  2. The receiving authority checks completeness
  3. If complete, the filing is accepted and a filing record number (备案号) is issued — typically within 5 working days of completeness acceptance
  4. The device may be placed on the market once the filing record number is issued

Changes to Class I filed devices​

Changes to a filed device that affect the product technical requirements must be notified to the filing authority. NMPA Order No. 47 specifies which changes require a new filing submission vs a simple update notification.

Production filing for domestic Class I manufacturers​

Domestic manufacturers of Class I devices must also complete a production filing (生产备案) with the district/county authority. This is separate from the product filing and covers the manufacturing site.

Disclaimer

Content on this site is written with AI assistance and is intended as a navigation aid only. Always verify against official NMPA sources before making regulatory decisions. Not affiliated with NMPA or any Chinese Government body. Not legal or regulatory advice.