The validity period is five years.
According to the "supervision and management of the production of medical devices" in order to strengthen the supervision and management of the production of medical devices, standardize the production of medical devices, to ensure that medical devices are safe and effective.
According to the "supervision and management of medical devices regulations" developed by the "supervision and management of medical device production" Article XIII "medical device production license" is valid for five years, set out the license number, enterprise name, legal representative, responsible for the enterprise, residence, production address, the production range, the issuance of licensing department, the date of issuance and validity period and other matters.
Extended information:
Medical device production license classification:
Medical device manufacturer of the first class:
Starting the first class of medical device manufacturers, should have the production of products with the production of appropriate production conditions, and should be in the receipt of the business license within 30 days, fill out the "first class of medical device manufacturer registration form", "medical device manufacturer registration form". Medical Device Manufacturer Registration Form", to the location of the province, autonomous region, municipality directly under the Central Government (food) drug supervision and management department in writing.
The second class, the third class of medical device manufacturers:
(a) the enterprise's production, quality and technical personnel should have the appropriate professional competence with the production of medical devices, and master
the national supervision and management of medical devices and the laws, rules and regulations, as well as related product quality, technology. The person in charge of quality shall not
simultaneously serve as the person in charge of production;
(b) the proportion of technical personnel with junior title or technical secondary education or above in the enterprise shall be compatible with the production of products
requirements;
(c) the enterprise shall have the production of products and production scale of the production of equipment, production, warehousing sites and environment. Enterprises
Enterprise production of medical devices have special requirements for the environment and equipment, etc., should be in line with national standards, industry standards and relevant state regulations;
Baidu Encyclopedia-Medical Device Manufacturing License