Legal analysis: at least the current medical device regulations do not provide. There are many varieties of medical devices, it is not good to generalize. However, the general provisions of the electrical class of companies for one year. Sterile products sterile expiration date of 2 years. Reagent class a few months to 1 year are available.
Legal basis: "Chinese People's **** and State 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, 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 People's Republic of China*** and the State shall comply with these Regulations.
Article 3 The Food and 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 in their respective areas of responsibility for supervision and management of medical devices. The food and drug administration department of the local people's government at or above the county level is responsible for the supervision and management of medical devices in the administrative area. The relevant departments of the local people's government at or above the county level are responsible for the supervision and management of medical devices within their respective scope of responsibilities. Food and drug supervision and management department of the state council shall cooperate with the relevant departments of the state council, the implementation of national medical device industry planning and policy.
Article 4 The state of medical devices in accordance with the degree of risk to implement classification management.
The first category is a low degree of risk, the implementation of routine management can ensure the safety and effectiveness of medical devices. The second category is a moderate risk, need to strictly control the management to ensure its safety and effectiveness of medical devices. The third category is a high risk, need to take special measures to strictly control the management to ensure the safety and effectiveness of medical devices. Evaluation of the degree of risk of medical devices should take into account the intended purpose of the medical device, structural features, methods of use and other factors. The Food and Drug Administration under the State Council is responsible for formulating the classification rules and classification catalog of medical devices, and analyzing and evaluating the risk changes of medical devices in a timely manner according to the production, operation and use of medical devices, and adjusting the classification catalog. The development and adjustment of the classification directory shall fully listen to the opinions of the medical device production and operation enterprises as well as the use of units, industry organizations, and reference to the international medical device classification practice. Classification of medical devices catalog should be published to the community.