Medical device license

Legal Analysis: To start a Class I medical device manufacturing enterprise, it should have the production conditions suitable for the products it produces, and should fill in the Registration Form of Class I medical device manufacturing enterprise within 30 days after obtaining the business license, and inform the local province, autonomous region and municipality directly under the Central Government (food) drug supervision and administration department in writing.

Legal basis: Measures for the Supervision and Administration of Medical Device Production

Article 7 To engage in the production of medical devices, the following conditions shall be met:

(1) Having a production site, environmental conditions, production equipment and professional technicians suitable for the medical devices produced;

(2) Having a quality inspection institution for medical devices produced or full-time inspectors and inspection equipment;

(3) Having a management system to ensure the quality of medical devices;

(4) Having the ability of after-sales service suitable for the medical devices produced;

(five) meet the requirements of product development and production process documents.

Article 8 To set up Class II and Class III medical device manufacturing enterprises, they shall apply to the food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government for production licenses, and submit the following materials:

(a) a copy of the business license and organization code certificate;

(2) A copy of the registration certificate and product technical requirements of the medical devices produced by the applicant enterprise;

(3) Copies of the identity certificates of the legal representative and the person in charge of the enterprise;

(four) the identity, education and title certificate of the person in charge of production, quality and technology;

(5) List of academic qualifications and titles of employees in production management and quality inspection positions;

(six) the production site certification documents, if there are special requirements for the production environment, it shall also submit a copy of the facilities and environmental certification documents;

(seven) the main production equipment and inspection equipment directory;

(eight) quality manuals and program documents;

(9) Process flow chart;

(10) authorization certificate of the agent;

(eleven) other supporting materials.