Medical device purchase inspection records should be kept until a few years after the expiration date of medical devices

2 years. Medical device use units should be true, complete and accurate records of import inspection. Incoming inspection records should be kept until the expiration of the specified period of use of medical devices after 2 years or 2 years after the termination of use. Large medical device purchase inspection records should be kept until the expiration of the specified period of use of medical devices 5 years after the expiration or termination of 5 years; implantable medical devices purchase inspection records should be permanently stored. Medical device use units should be properly preserved purchase of Class III medical devices of the original information to ensure that the information is traceable.

I. The state of medical devices in accordance with the degree of risk in the implementation of categorized management:

1, low risk, the implementation of routine management can ensure the safety and effectiveness of medical devices.

2, with moderate risk, need to strictly control the management to ensure the safety and effectiveness of medical devices.

3, with high risk, need to take special measures to strictly control the management to ensure the safety and effectiveness of medical devices.

Two, the first class of medical device products for the record and apply for registration of Class II, Class III medical device products, should be submitted to the information:

1, product risk analysis information;

2, product technical requirements

3, product inspection reports

4, clinical evaluation information;

5, product specifications and labeling Sample

6, and product development, production and quality management system documents;

7, to prove that the product is safe, effective and other information required.

Legal basis: "Medical Device Supervision and Administration Regulations"

Article 1 In order to ensure the safety and effectiveness of medical devices, to protect human health and safety of life, and to promote the development of the medical device industry, the formulation of these regulations.

Article 2 The development, production, operation and use of medical devices and their supervision and management within the territory of the Chinese People's Republic of China shall be governed by these Regulations.

Article 3 The Drug Administration under the State Council is responsible for the supervision and management of medical devices throughout the country.

The relevant departments of the State Council are responsible for the supervision and management of medical devices within their respective areas of responsibility.