From the beginning of the device registration.
"Supervision and Administration of Medical Devices Regulations" has corresponding provisions:
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 six months before the expiration of the original registration department to apply for renewal of registration.
Except for the third paragraph of this article, the continuation of the application for registration of food and drug supervision and management departments should be in the medical device registration certificate before the expiration of the decision to grant the continuation. If the decision is not made after the expiration date, the renewal shall be deemed to be granted.
Extended information:
Related Laws and Regulations on the Supervision and Administration of Medical Devices:?
Article 23 The quality management standard for the production of medical devices shall make clear provisions for the design and development of medical devices, production equipment conditions, procurement of raw materials, control of the production process, the enterprise's institutional setup and staffing and other matters affecting the safety and effectiveness of medical devices.
Medical device manufacturers shall, 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; strictly in accordance with the registered or filed by the technical requirements of the product production organization.
Article 24? Medical device manufacturers shall regularly on the operation of the quality management system for self-examination, and to the local provincial, autonomous regions, municipalities directly under the Central People's Government of food and drug supervision and management department to submit a self-examination report.
Baidu Encyclopedia - Regulations for the Supervision and Administration of Medical Devices