Active Medical Devices Contain Two Different Types Of Product Modules. How To Determine The Product Category And Classification Code?
2022-09-20
There are many cases of combination products in active medical devices. One product contains two independent functional modules, and each module belongs to a different classification category and code. In this case, the classification level should be managed according to the higher one of the two categories.
For the classification codes, if there is already clearly classified announcement, it shall prevail. If not, administrative counterparts may justify which module of the product is the major one and use the category and code of this module. If manufacture cannot justify, then either one can be used when submitting and no separate classification request is not needed.
For instance of the Integrated Surgical Equipment of Ultrasound and High Frequency, the category code of Ultrasound Surgical Equipment is 01-01-01 and the High Frequency Surgical Equipment is 01-03-01, both of which are class III device under 01 category, so the whole device is also class III. If the main function is the ultrasound surgical, then the application category code should be 01- 01-01.
