What qualifications do you need to operate medical devices?

The classification of medical devices in China is divided into three levels according to the degree of risk from low to high, and the administrative licensing authority required for their production and sales is also different:

First, medical devices are low-risk medical devices that can be guaranteed to be safe and effective through routine management, such as scalpels, surgical scissors, manual sickbeds, medical ice packs, and cooling stickers.

Its products and production activities are managed by the municipal food and drug supervision department with districts, and all business activities are liberalized, without permission or filing, just obtaining the business license issued by the industrial and commercial department.

Second, medical devices are medium-risk medical devices, which need strict control and management to ensure their safety and effectiveness, such as band-AIDS, condoms, thermometers, sphygmomanometers, oxygen generators, atomizers, etc., which are common in our daily life.

Its products and production activities are managed by the provincial food and drug supervision department, and the Medical Device Registration Certificate and the Medical Device Production License are issued respectively. Business activities shall be filed by the municipal food and drug supervision department with districts;

Third, medical devices are high-risk medical devices that need special measures to be strictly controlled and managed to ensure their safety and effectiveness, such as common infusion sets, syringes, intravenous indwelling needles, heart stents, ventilators, CT, magnetic resonance imaging, etc.

Its products and production and business activities are subject to licensing management by the State Administration, provincial food and drug supervision departments and municipal food and drug supervision departments with districts, and medical device registration certificates, medical device production licenses and medical device business licenses are issued respectively.

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