Legal analysis: in the medical device instructions and labeling regulations General Administration Decree No. 6 words in Article X in the tenth production date, use of the period and expiration date; on the date of production, expiration date, expiration date to the use of such definitions are very clear.
Legal basis: "Supervision and Administration of Medical Devices Regulations"
Article XV of the medical device registration certificate is valid for five years. The expiration of the validity of the need to renew the registration, shall be valid for six months before the expiration of the original registration department to apply for renewal of registration.
Article 23 of the quality management standard for the production of medical devices should be on the design and development of medical devices, production equipment conditions, raw materials procurement, production process control, enterprise organization and staffing and other matters affecting the safety and effectiveness of medical devices to make clear provisions. Medical device manufacturers should be in accordance with the requirements of the quality management standard for the production of medical devices, establish and improve the production of medical devices and ensure the effective operation of the quality management system; in strict accordance with the technical requirements of the registered or filed products to organize the production.