The first class of medical devices is a low degree of risk, the implementation of routine management can ensure the safety and effectiveness of medical devices, such as scalpels, surgical scissors, manual beds, medical ice packs, cooling patches, etc., its products and production activities by the municipal level of the location of the district Food and Drug Administration to implement record management. Business activities are all liberalized, neither permit nor record, only need to obtain a business license issued by the business sector.
2, Class II - Municipal Food and Drug Administration for the record of medical devices
The second class of medical devices is a medium risk, need to strictly control the management of medical devices to ensure their safety and effectiveness, such as our daily life in the common band-aid, condoms, thermometers, sphygmomanometers, oxygen concentrators, nebulizers, etc., its products and production activities by the municipal food and drug regulatory departments. Its products and production activities are licensed by the provincial food and drug regulatory authorities, and are issued with "Medical Device Registration Certificate" and "Medical Device Production License" respectively. Business activities by the municipal food and drug regulatory departments to implement record management;
3, Class III - State Drug Administration for medical device license
Class III medical devices is a higher risk, the need to take special measures to strictly control the management in order to ensure the safety and efficacy of medical devices, such as common infusion sets, syringes, intravenous needles, cardiac stents, respiratory machines, CT, nuclear magnetic **** vibration, etc., its products and production and management activities by the State Administration, provincial food and drug regulatory authorities and municipal food and drug regulatory authorities to implement licensing and management, respectively, issued by the "Certificate of Registration of Medical Devices," the "Medical Device Manufacturing License," "Medical Device License," "medical device business license.
Legal basis:
Methods for the Administration of Medical Device Business License
Article I In order to strengthen the supervision and management of medical device business license, according to the "supervision and management of medical devices regulations", the development of these measures.
The second "medical device business license" issuance, renewal, change and supervision and management of the application of these measures.
Article III of the operation of second and third class medical devices should hold a "medical device business enterprise license", but in the circulation process through routine management can ensure its safety, effectiveness of a few second class medical devices can not apply for a "medical device business enterprise license". Do not need to apply for a "medical device business license" of the second class of medical devices by the State Food and Drug Administration to develop a product list.
Article IV of the State Food and Drug Administration in charge of the national "medical device business license" supervision and management. Provinces, autonomous regions, municipalities directly under the Central (food) Drug Administration is responsible for the jurisdiction of the "medical device business license" of the issuance, renewal, change and supervision and management work. Municipal (food) drug supervision and management agencies or provinces, autonomous regions, municipalities directly under the Central (food) drug supervision and management departments set up directly by the county (food) drug supervision and management agencies are responsible for the jurisdiction of the "medical device business license" of the day-to-day supervision and management work.