Medical device production license process

To start the first class of medical device manufacturers, should have and the production of products suitable for the production conditions, and should be in the receipt of business license within 30 days, fill out the "first class of medical device manufacturer registration form" to the local provinces, autonomous regions and municipalities directly under the Central Government (food) drug supervision and management department informed in writing.

Opening the second and third class medical device manufacturers must have the following conditions:

1, with the production of medical devices and production sites, environmental conditions, production equipment and professional and technical personnel;

2, there is the production of medical devices for quality inspection of the organization or a full-time inspectors and inspection equipment;

3, there are Ensure the quality of medical devices management system;

4, with the production of medical devices compatible with the after-sales service capabilities;

5, in line with the product development, production process documentation requirements;

6, has obtained the second and third medical device product registration certificate, has been in accordance with the relevant provisions of the business registration;

7, in accordance with the "Code for the Quality Management of Medical Device Manufacturing" of the "medical device manufacturing quality control standards" of the "medical device manufacturing quality control standards" of the "medical device manufacturing quality control standards" of the "medical device manufacturing quality control standards" of the "medical device manufacturing quality control standards. Code for the Quality Management of Medical Device Manufacturing" requirements to establish a quality management system for the production of medical devices;

8, for the production of medical devices license applications for personnel with appropriate professional knowledge, familiar with the rules and regulations of the production of medical devices and quality management of laws, regulations and technical requirements.

Legal basis: "Regulations for the Supervision and Administration of Medical Devices"

Article 20 Engaged in the production of medical devices, shall have the following conditions:

(a) with the production of medical devices suitable for the production of sites, environmental conditions, production equipment, and professional and technical personnel;

(b) the production of medical devices quality inspection. (B) the production of medical devices for quality inspection of institutions or full-time inspectors and inspection equipment;

(C) to ensure that the quality of medical devices management system;

(D) with the production of medical devices compatible with the after-sales service capabilities;

(E) product development, production process documentation requirements.

Article 28 commissioned the production of medical devices, the commissioning party is responsible for the quality of the commissioned production of medical devices. The entrusted party shall be in accordance with the provisions of these regulations, with the corresponding production conditions of medical devices manufacturer. The commissioning party shall strengthen the management of the commissioned production behavior, to ensure that it is in accordance with the statutory requirements for production.

High-risk implantable medical devices shall not be entrusted with the production of specific directories by the State Council Food and Drug Administration to develop, adjust and publish.