Class II filing conditions for 6840 medical devices

The second category of medical devices refers to medical devices whose safety and effectiveness should be controlled, including X-ray filming machines, B-ultrasound, microscopes and biochemical instruments. , belonging to the second category of medical devices. Here, I would like to share with you the procedures and conditions for filing second-class medical devices.

Conditions for filing medical devices of category II:

1, and the office space required for filing shall not be less than 100 m2;

2. The warehouse area required for filing is not less than 60 square meters.

3. The business scope of the business license needs to include the sales and operation of Class II medical devices before the application can be made. If not, add;

4. Personnel requirements:

1 quality manager: bachelor degree or above in medical devices, pharmacy or medicine, or 3 with corresponding professional intermediate titles, quality supervisor 1 name, and 2 quality managers;

Warehouse manager: college degree or above 1 name;

Computer Administrator: College degree or above.

The second category of medical devices refers to medical devices whose safety and effectiveness should be controlled, including X-ray filming machines, B-ultrasound, microscopes, biochemical instruments, etc., which belong to the second category of medical devices.