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Class I Medical Device Filing/Recording

According to the "Regulations on the Supervision and Administration of Medical Devices" (No. 739), medical devices are classified and managed according to the degree of risk.

Class I medical device is a medical device with a low degree of risk, and the implementation of routine management can ensure its safety and effectiveness. Overseas medical device manufacturers need to entrust a domestic agent to file with the NMPA.

Regulation:

"Regulations on the Supervision and Administration of Medical Devices" (No. 739)

Service Process:

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Administrative Fee:

Free

Time distribution:

Accept and review on the spot, if the document needs to be supplemented and revised, applicants will be notified on the spot.

Related service:

  • Product classification determination

  • Class I medical device filing and filing change

  • Class II/III medical device registration, registration change and renewal

  • Product testing and rectification technical support

  • Technical files compilation

  • Medical device registration under the MAH system

  • Registration of imported-to-domestic products

  • Follow-up and correction of medical device registration technical review