People who are engaged in medical devices know that all medical products must go through the CFDA, otherwise they cannot be applied to the medical field.
Today, we briefly understand the relevant knowledge about CFDA.
Before starting the medical product CFDA registration and certification program, we must first determine the category of the corresponding product. According to the "Regulations on the Supervision and Management of Medical Devices," the registration of Class I devices shall be examined and approved by the drug regulatory department of the municipal people's government in the district, and a registration certificate shall be issued. The registration of Class II devices shall be made by the people's government of the province, autonomous region or municipality directly under the Central Government. The supervisory and administrative department shall review and approve and issue a registration certificate.
The registration of Class III equipment shall be examined and approved by the State Food and Drug Administration and a registration certificate shall be issued. Medical device companies can only manufacture and sell medical devices after they have obtained medical device product registration certificates. For Class II and Class III medical devices that apply for registration, they shall be registered and tested according to the applicable product standards by the State Food and Drug Administration in conjunction with the medical device inspection agencies approved by the General Administration of Quality Supervision, Inspection and Quarantine; Instruments should also be clinically verified before submitting a registration application.