According to the Regulations for the Supervision and Administration of Medical Devices, Class III medical devices refer to general medical devices without strict control requirements, including some common diagnostic appliances and sterilizing devices. In order to ensure the safety and effectiveness of medical devices, China has implemented market access management measures for medical devices, in which Class III medical devices need to be filed. The filing mainly consists of medical device manufacturers and operators submitting filing applications to the State Food and Drug Administration, providing relevant materials and information, and approving the filing after examination. Before filing, the enterprise shall formulate product quality standards, performance indexes and test methods, etc. according to the medical device standards and technical requirements, and carry out necessary product inspection, test and evaluation. After filing, the enterprise shall mark the filing certificate number and filing voucher number on the product package. The purpose of the record is to ensure that the production and operation of medical devices in line with national standards and requirements to improve the safety, effectiveness and reliability of medical devices. At the same time, the record is also one of the necessary access conditions for medical devices to enter the market.
What is the validity period of the filing of Class III medical devices? According to the "supervision and management of medical devices regulations," the third class of medical devices for the record is valid for five years from the date of issuance of the record certificate. Three months before the expiration of the validity of the filing certificate, the filing enterprise shall apply to the original filing organization for change or re-filing.
The filing of Class III medical devices is one of the measures for the management of medical device market access, which protects the health and safety of patients by standardizing and regulating the production and operation of medical devices. The filing enterprise should be in accordance with the requirements of the regulations, fulfill the filing obligations, and according to the actual situation in a timely manner to change or re-filing.
Legal basis:
"Supervision and management of medical device business" Article 4 According to the degree of risk of medical devices, medical device business implementation of classification management. The operation of Class III medical devices license management, the operation of Class II medical devices for the record management, the operation of Class I medical devices do not require licensing and filing.