1. The applicant submits the application materials to the relevant departments;

2, the relevant departments to accept the application of the applicant;

3, to the actual scene for investigation and product audit;

4, granted three kinds of medical device license.

The materials required for the license registration of Class III medical devices are as follows:

1, name and business scope of the enterprise, registered capital and proportion of shareholders' contribution, and identification of shareholders;

2, medical device product registration certificate, supplier business license, license and authorization;

3. Quality management documents, etc.

4. Certificates, identity certificates and resumes of two or more medical professionals or related professionals;

5, in line with the requirements of medical equipment business office space and warehouse proof;

6. Articles of Association, resolutions of shareholders' meeting, etc.

7. ID card and employment certificate of financial personnel;

8. Other relevant materials.

laws and regulations

Regulations on the supervision and administration of medical devices

Article 14 The following materials shall be submitted when applying for the filing of Class I medical device products and for the registration of Class II and Class III medical device products:

(a) product risk analysis data;

(2) product technical requirements;

(3) product inspection report;

(4) Clinical evaluation data;

(five) product specifications and sample labels;

(6) Quality management system documents related to product development and production;

(seven) other information required to prove the safety and effectiveness of the product.

The product inspection report shall meet the requirements of the drug supervision and administration department of the State Council, which may be the self-inspection report of the applicant and the filer of medical device registration, or the inspection report issued by a qualified medical device inspection institution.

In accordance with the provisions of Article 24 of these regulations, those who are exempted from clinical evaluation may be exempted from submitting clinical evaluation data.

Applicants and filers of medical device registration shall ensure that the materials submitted are legal, true, accurate, complete and traceable. Article 16 To apply for the registration of Class II medical devices, the applicant for registration shall submit the application materials to the pharmaceutical supervisory and administrative department of the local people's government of the province, autonomous region or municipality directly under the Central Government. To apply for the registration of Class III medical devices, the applicant for registration shall submit the application materials to the drug supervision and administration department of the State Council.

An overseas registration applicant who exports Class II and Class III medical devices to China shall submit the registration application materials and the certification documents of the competent department of the country (region) where the registration applicant is located to the drug supervision and administration department of the State Council. For innovative medical devices that are not listed overseas, there is no need to submit the certification documents that the competent department of the country (region) where the registration applicant is located allows the medical devices to be listed for sale.

The pharmaceutical supervisory and administrative department of the State Council shall stipulate the procedures and requirements for the registration and examination of medical devices, and strengthen the supervision and guidance on the registration and examination of the pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government.