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Quickly understand the difference between Class I, Class II and Class III medical device licenses
Date：2022-03-23 browse：328
1, Class A - do not apply for medical device license
The first type of medical device is a low risk, the implementation of conventional management can ensure its safety and effective medical devices,
such as scalpels, surgical scissors, manual beds, medical ice packs, cooling stickers, etc.,
its products and production activities by the municipal food and drug regulatory authorities in the location of the district to implement record management.
Business activities are all liberalized, neither licensing nor filing, only need to obtain a business license issued by the industry and Commerce Department.
2, Class II - the Municipal Food and Drug Administration for the record of medical device management
The second type of medical devices are medical devices with moderate risk that need to be strictly controlled and managed to ensure their safety and effectiveness,
such as band-aids, condoms, thermometers, blood pressure monitors, oxygen producers, atomizers, etc.,
whose products and production activities are licensed by the provincial food and drug regulatory authorities.
The Medical Device Registration Certificate and the Medical Device Production License shall be issued respectively.
Business activities shall be administered by the food and drug regulatory department of the districted city;
3, third class - the State Food and Drug Administration for medical device license
The third type of medical devices are those with high risks and need to take special measures to strictly control and manage them to ensure their safety and effectiveness,
such as common infusion sets, syringes, intravenous indentation needles, heart stents, ventilators, CT, MRI, etc.
Its products and production and business activities are respectively licensed by the State Administration,
the provincial food and drug regulatory department and the food and drug regulatory department of the city divided into districts,
and issued the Medical Device Registration Certificate, the Medical Device Production License, and the Medical Device Business License.
