According to the Regulations of the People's Republic of China on the Administration of Medical Devices, Class II medical devices refer to those devices that have an expected main effect on the human body, and are diagnostic, therapeutic or orthopedic by means of electromechanical, optical and other methods. The product registration process is mainly divided into the following steps: 1. application: to the State Drug Administration (or its authorized local drug regulatory agencies) to submit an application for registration, and submit product-related information. 2. clinical trials: clinical trials on the product to verify its safety and effectiveness. The test results need to comply with the relevant provisions before entering the next step of the audit. 3. technical review: technical review of the product by professional organizations, including product structure, function, performance and other indicators, as well as the production process and quality control and other aspects of the content. 4. quality evaluation: quality evaluation of the product, including production licenses and quality assurance of goods and other relevant supporting documents for the audit. 5. payment of taxes and fees and Registration Certificate Collection: After the application is approved, it is necessary to pay the relevant taxes and fees to collect the medical device product registration certificate. The registration certificate is a necessary document for sales and use.
What is the time cycle for Class II medical device registration? The time cycle for Class II medical device registration is long, often taking more than 3 years. Among them, clinical trials and technical reviews are longer and take up most of the time. However, the exact time cycle also depends on the progress of the review by the drug regulatory authorities and the special circumstances of the product.
The registration of Class II medical device products is a necessary procedure for the production and sale of medical devices, and its audit process is long and cumbersome. However, only after the audit and obtaining the registration certificate, it can be legally sold and used in the market. Therefore, manufacturers need to take all aspects of the registration process seriously to ensure product quality and safety.
Legal basis:
"Regulations for the Supervision and Administration of Medical Devices" Article 13 The first class of medical devices to implement product filing management, the second class, the third class of medical devices to implement product registration management. Medical device registrants, filers should strengthen the quality management of medical devices throughout the life cycle, the development, production, operation, use of the whole process of medical devices, safety and effectiveness of the responsibility according to law.