Class II medical device production license how to handle, for how long?

Currently, China's medical device management is divided into three categories: the first category refers to the routine management to ensure the safety and effectiveness of the product; the second category is the need to control the product; the third category is with a high degree of risk, must be strictly controlled products.

The opening of the second class of medical equipment business enterprises, should be to the provincial, autonomous regions and municipalities directly under the Central People's Government drug supervision and management department for the record; the opening of the third class of medical equipment business enterprises, should be by the provincial, autonomous regions and municipalities directly under the Central People's Government drug supervision and management department for examination and approval, and issued the "medical equipment business enterprise license".

The second class of medical devices is a medium risk, need to strictly control the management to ensure its safety and effectiveness of medical devices, such as band-aids, condoms, thermometers, blood pressure monitors, oxygen concentrators, nebulizers, etc., common in our daily life, its products and production activities by the provincial food and drug regulatory departments to implement licensing management, respectively, issued by the "Certificate of Registration of Medical Devices" and "Medical Device Manufacture License". License". Business activities by the municipal food and drug regulatory departments to implement record management.

Medical device license requirements

1, apply for a medical device license at least five people.

2, the scope of business includes Class B medical devices, the person in charge of the enterprise should have a medical device related professional bachelor's degree or above or medical device related professional intermediate title.

3, the scope of business containing Class D medical devices, should be equipped with a junior optometrist or above the title of professional and technical personnel.

4, the person in charge of the enterprise and the person in charge of quality shall not be concurrent with each other.

5, Shenzhen, "Medical Device Business License", "Medical Device Manufacturing License"

The above content is written by TEMPUS International Yang manager according to the actual experience, without permission please do not reproduce!