Medical equipment class I, class II, class III difference is: medical devices with different levels of risk
I, the first class is a low level of risk, the implementation of routine management can ensure that the safety and effectiveness of medical devices.
(such as scalpels, surgical scissors, manual beds, medical ice packs, cooling paste, etc., business activities are all liberalized, neither permit nor record, only need to obtain a business license issued by the business sector.)
Two, the second category is with moderate risk, need to strictly control the management to ensure its safety and effectiveness of medical devices.
(For example, band-aids, thermometers, blood pressure monitors, oxygen concentrators, nebulizers and so on, which are common in our daily life. Business activities by the municipal food and drug supervision department in the district to implement record management.)
Third, the third category is a higher risk, need to take special measures to strictly control the management to ensure its safety and effectiveness of medical devices.
(For example, common infusion sets, syringes, intravenous retention needles, cardiac stents, respiratory machines, CT, nuclear magnetic **** vibration, etc., business activities by the municipal food and drug supervision department of the city of the district to implement licensing management, to obtain the "Medical Device License".)
Warm tips:
The validity of the second class of medical device business filing certificate is: According to the "supervision and management of medical devices regulations" developed by the "supervision and management of medical equipment production methods," Article XIII of the "production of medical devices license" is valid for five years, the expiration of the need to apply for renewal six months in advance.
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