On this page, you will find frequently asked questions regarding active medical device registration in China. The FAQ list is updating…
Q: Ultrasonic high-frequency integrated surgical equipment includes both ultrasonic device and high-frequency surgical devices. How should the product be classified? How to fill in the classification code? Do I need to apply for a classification?
There are many cases of combined products in active medical devices. It is often the case that one product contains two separate functional modules, and each module belongs to a different sub-category or classification code. In this case, product categories should be a higher classification.
For classification codes, if such products are clearly defined, the definition documents shall prevail. If there is no definition, the applicant can determine which module is the main module, and fill in the sub-category or code of the module; if it cannot be judged, fill in the sub-category or code of any module, and there is no need to apply for separate classification.
Taking ultrasonic high-frequency integrated surgical equipment as an example, the ultrasonic surgery equipment classification code is 01-01-01, and the high-frequency surgical equipment classification code is 01-03-01, both of which belong to the Class III medical device under the 01 sub-category, so the overall product category is also Class III. If the main function of the product is ultrasonic surgery equipment, you can fill in the classification code 01-03-01. If you are not sure, you can also fill in 01-00.CMDE. Division II. 2019.10.31
Q: When applying for the PET/CT product registration, if the CT has obtained the registration certificate, how should the CT-related device description and research documents (V&V protocols/reports) be provided?
The information of the manufacturer, model number, and registration certificate number should be specified in the device description. It also necessary to explain the differences between the CT in the PET/CT system and the CT that has obtained the registration certificate. Analyze the differences and submit research data on the impact of differences on safety and effectiveness. If there is no difference between the CT part and the original registration certificate, the research data of the PET/CT system can be provided without providing the data of the CT part separately.
There are many cases of combined products in active medical devices. It is often the case that one product contains two separate functional modules, and each module belongs to a different sub-category or classification code. In this case, product classification should be the higher one.CMDE. Division I. 2019.09.20