How to apply for a medical device license class I, class II, class III

In the medical business enterprise must have a medical device license, in the operation of a class of medical devices is not required to apply for documents, only business registration; operation of Class II medical devices need to be filed with the municipal bureau, the issuance of the record voucher; operation of Class III medical devices are required to issue a medical device license. (Business license is not a business, individual households are not allowed to apply for a medical device license)

The conditions for the medical device license:

1. need to have the appropriate size and scope of operation of the appropriate quality management personnel (quality management personnel should have a nationally recognized relevant academic documents)

2. the need to have the scale of operation and the scope of operation of the independent business premises

3. need to have a business license to apply for a medical device license. Independent business premises appropriate to the scale and scope of business

3. need to have appropriate storage conditions, including storage equipment, equipment in line with the medical device products

4. have a complete management system (purchasing, purchase, acceptance, warehousing, out of the warehouse to review the quality of tracking and reporting of adverse events system)

5. should be compatible with the medical device products and after-sales service training and capabilities Ability to

6. apply for a medical device license, must pass the inspection and acceptance of the Food and Drug Administration

Materials for the medical device license:

1. application form

2. application for pre-approval of the name of the enterprise

3. quality management personnel of the enterprise's identity card, a copy of the academic degree or title and resume

4. the organizational structure of the enterprise and the application for pre-approval of the name of the enterprise

5. the quality of the enterprise's products and services

6. p>4. Organizational structure and functions of the enterprise

5. The registered address and warehouse of the enterprise's geographic location map, floor plan, proof of property rights

6. Product management system of the enterprise

7. Scope of the enterprise

For the process of the medical device license:

1. Submission of materials

2. Review of the materials

3. Verification of medical devices:

4. p>

3. Verification of address

4. Approval

This article introduces the materials and conditions required for a medical device license, which is needed to operate a medical device appliance in a Chinese enterprise