Implantable medical device sales records kept for several years

2 years. Medical device use units should be true, complete and accurate records of incoming inspection. Incoming inspection records should be kept until the expiration of the specified period of use of medical devices 2 years after the expiration or termination of the use of 2 years. 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. The drug supervision and management department of the State Council is responsible for the supervision and management of medical devices nationwide. The relevant departments of the State Council are responsible for the supervision and management of medical devices within their respective scope of responsibilities. Provincial food and drug supervision and management departments are responsible for the supervision and management of medical device network trading services.

Local food and drug supervision and management departments at or above the county level are responsible for the supervision and management of network sales of medical devices in the administrative area. Enterprises engaged in the online sale of medical devices, medical device network trading services third-party platform providers should comply with medical device laws, regulations and norms, establish and improve the management system, in accordance with the law and integrity of the business, to ensure the quality and safety of medical devices. Engaged in medical device network sales of enterprises, refers to the network sales of medical devices through the medical device marketing license holder (i.e., medical device registrant or filer, hereinafter referred to as the holder) and medical device production and management enterprises.

The state of medical devices in accordance with the degree of risk to implement the classification and management:

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

Legal basis:

"Regulations for the Supervision and Administration of Medical Devices"

Article I In order to ensure the safety and efficacy of medical devices, to protect human health and safety of life, and to promote the development of the medical device industry, the enactment 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 **** and the State shall be governed by these Regulations.