Medical Device License Application

How to apply for a medical device license?

The medical device manufacturing license is a medical device manufacturer must hold the documents, issued by the local Drug Administration audit. The opening of medical device manufacturers should be in line with national medical device industry development planning and industrial policy. The State Food and Drug Administration should be in accordance with the "supervision and management of medical devices regulations" of the provisions of the start-up conditions of medical device manufacturers to make specific provisions for different categories of medical devices to develop appropriate quality management standards for the production of medical devices, and organization and implementation.

Medical device license application process:

1. Production, quality and technical personnel should have the production of medical devices and the production of appropriate professional competence, and master the national supervision and management of medical devices, laws, rules and regulations, as well as related product quality, technical regulations. The person in charge of quality shall not be concurrently responsible for the production;

2. Enterprises above the primary title or technical personnel with secondary education or more than the proportion of the total number of employees should be compatible with the production of products;

3. Enterprises should have and the production of products and production scale of production equipment, production, storage space and environment. Enterprises to produce the environment and equipment and other special requirements of medical devices, should be in line with national standards, industry standards and relevant state regulations;

4. Enterprises should set up quality inspection organizations, and with the production of varieties and production scale of quality inspection capabilities;

5. Enterprises should be preserved with the production and operation of medical devices related to laws, regulations, rules and relevant technical standards.

To open the third class of medical device manufacturers, in addition to the above requirements should be met, but also should have the following conditions:

1. Quality management system in line with the requirements of the internal auditor not less than two;

2. Intermediate or higher title or college degree or above in the relevant professional and full-time technical staff of not less than two.

Open the second, third-class medical device manufacturers, should fill out the "Medical Device Manufacturer License (start-up) Application Form" and submit the following materials:

1. Legal representative, the person in charge of the basic information and qualifications;

2. Business administration issued by the proposed business name pre-approval notice;

3. Production site documents;

4. p> 4. enterprise production, quality and technical personnel in charge of the curriculum vitae, academic or professional title certificate; relevant professional and technical personnel, skilled workers registration form, and indicate the department and position; senior, intermediate, junior technical personnel ratio table;

5. proposed scope of production products, varieties and related product profile;

6. the main production equipment and testing equipment catalog;

7. production Quality management documents directory;

8. To produce the product process flow diagram, and indicate the main control items and control points;

9. Production of sterile medical devices, should provide production environment test reports.

Changshun enterprise, medical device record industry professional registration agent, 15 years of experience in team medical equipment consulting services, 300 + people business team, expedited for a class of Class II Class III medical device documents, green channel, 10 days package to get the certificate. Entity business, free to provide door-to-door explanation of consulting services.