Medical device production license

Medical device manufacturing license needs to be submitted to the following materials:

1, application form;

2, proof of registration of medical devices;

3, production of medical devices, quality management normative documents;

4, proof of registration of medical devices products;

5, medical devices production site and equipment photos;

< p>6, medical device manufacturer business license copy and other relevant qualification documents.

Medical device production needs to be managed in accordance with relevant national laws and regulations, including but not limited to the following:

1, production license: medical device manufacturers need to obtain a medical device production license in the State Drug Administration, in order to start the production of medical devices;

2, the production of quality management system: medical device manufacturers need to establish a quality management system in line with national standards to ensure the quality and safety of medical devices;

3, product registration: medical device manufacturers need to register the production of medical devices, to obtain the product registration certificate issued by the State Drug Administration before they can be sold in the market;

4, production supervision: medical device manufacturers need to be subject to the national drug supervision and administration department to ensure that the production process complies with the relevant standards and regulations.

In summary, medical devices are related to human health and life safety, so the production of medical devices should attach great importance to the quality and safety of products, strictly in accordance with the relevant standards and regulations for production and management, to ensure the quality and safety of medical devices. At the same time, when consumers buy and use medical devices, they also need to choose products that comply with the regulations, and comply with the instructions and precautions for use to ensure their own safety and health.

Legal basis:

"The Chinese people*** and the State of medical equipment business license management measures" Article 6

Application for "medical device business license" should have the following conditions:

(a) with the scale and scope of business with the quality of the quality management body or full-time quality management personnel.

Quality management personnel should have a nationally recognized professional qualifications or titles;

(B) with the scale and scope of operation of relatively independent premises;

(C) with the scale and scope of operation of the storage conditions, including the requirements of the characteristics of the medical device product with the storage facilities, equipment;

(d) shall establish and improve the product quality management system, including procurement, purchase and acceptance, warehousing and storage, out of the warehouse review, quality tracking system and the reporting system of adverse events;

(e) shall have the ability to provide technical training and after-sales service compatible with the medical device products it operates or agree to provide technical support by a third party.