Class II medical device business filing form for

Application materials

1, the second class of medical equipment business filing form.

2, a copy of the business license, a copy of the organization code certificate; branches also need to provide a copy of the head office business license and the second class of medical devices business filing certificate.

3, the legal representative, the person in charge of the enterprise, the quality of the person in charge of identification, education or title certificate.

4, the enterprise organization and departmental setup description.

5, the scope of business, business mode description.

6, business premises, warehouse address of the geographic location map, floor plan, documents proving ownership of the house or lease agreement (documents proving ownership of the house) copy.

7, business facilities, equipment catalog.

8, business quality management system, work procedures and other documents catalog.

9, the operator's authorization certificate (to specify the authorization, the operator's name, identity number, etc., and provide a copy of the operator's ID card).

10, the authenticity of the information submitted to the statement.

Common devices (including but not limited to the following devices):

thermometer, sphygmomanometer, contraceptive devices, home blood glucose meters, pregnancy diagnostic test strips, wheelchairs, 6820 general diagnostic equipment, 6820 general diagnostic equipment, 6866 medical polymer materials and products, medical sanitary masks, 6864 medical hygiene materials and dressings, 6840 clinical test and analysis instruments, 6856 ward Nursing equipment and apparatus, etc.