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Imported Device Registration

All imported medical devices β€” regardless of class β€” are registered with or filed with national NMPA. The overseas manufacturer cannot directly submit a registration application; all submissions must be made through a China Agent (代理人) who is a legal entity registered in China.

China-unique

National NMPA jurisdiction over all imported devices (including Class I and II) means imported devices face a single registration authority β€” unlike domestic devices, where class determines which level of government is responsible.

The China Agent's role in registration​

The China Agent:

  • Submits the application on behalf of the overseas manufacturer
  • Is named on the registration certificate
  • Bears joint liability with the overseas manufacturer for product quality
  • Is the NMPA contact for post-market obligations (adverse event reporting, recalls)

For a full description of the China Agent role, see China Agent.

Key dossier elements for imported devices​

In addition to the standard dossier (see Dossier Requirements), imported device applications must include:

  • Overseas manufacturer proof of legal status β€” business registration, Certificate of Free Sale or equivalent from the country of origin
  • China Agent authorisation letter β€” an original (or notarised copy) signed by an authorised representative of the overseas manufacturer, clearly authorising the named China Agent to submit the registration application and act on the manufacturer's behalf for all regulatory communications and post-market obligations
  • Quality system certificate β€” NMPA accepts ISO 13485 certificates for imported devices (from accredited certification bodies)
  • Country of origin approval documentation β€” approval from the country where the device is manufactured (if applicable)
  • Chinese translation of key dossier documents

Overseas GMP inspection​

Overseas GMP Inspection

NMPA reserves the right to conduct overseas GMP inspections (or request third-party inspection reports) of imported device manufacturers at any time. For Class III imported devices, an overseas GMP inspection is frequently triggered during the review process and must be completed before a registration certificate is issued. The overseas manufacturer must ensure its production facility complies with ISO 13485 or equivalent standard. Inspection findings that reveal non-compliance may result in supplemental requests or rejection. See NMPA GMP Inspections for inspection procedures and timelines.

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.