The Regulations on the Supervision and Administration of Medical Devices has corresponding provisions:
Fifteenth medical device registration certificate is valid for 5 years. If it is necessary to renew the registration at the expiration of the validity period, an application for renewal of registration shall be filed with the original registration department six months before the expiration of the validity period.
Except in the circumstances specified in the third paragraph of this article, the food and drug supervision and administration department that receives the application for renewal of registration shall make a decision to approve the renewal before the expiration of the validity period of the medical device registration certificate. If no decision is made within the time limit, it shall be deemed as approval.
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Relevant laws and regulations of Regulations on Supervision and Administration of Medical Devices:
Twenty-third medical device production quality management standards should clearly specify the design and development of medical devices, production equipment conditions, raw material procurement, production process control, enterprise organization and staffing and other matters that affect the safety and effectiveness of medical devices.
Medical device manufacturers shall, in accordance with the requirements of the quality management standards for medical device production, establish and improve the quality management system suitable for the medical devices produced, and ensure their effective operation; Organize production in strict accordance with the technical requirements of registered or filed products.
Article 24? Medical device manufacturing enterprises shall regularly conduct self-inspection on the operation of the quality management system, and submit self-inspection reports to the local food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government.
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