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:

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