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.
"Regulations on the Supervision and Administration of Medical Devices" (No. 739)
Accept and review on the spot, if the document needs to be supplemented and revised, applicants will be notified on the spot.
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