The Third Batch Of Medical Device Product Classification Identification In 2022

Center for Medical Device Standardization Administration, a branch of NMPA, issued a summary of the third batch of medical device product classification identification on October 27, 2022.

A total of 388 medical device product classification results have been summarized from July to September 2022, of which 45 products were suggested to be regulated as Class III medical devices, 149 products were suggested to be regulated as Class II medical devices, 98 products were suggested to be regulated as Class I medical devices, 75 products were suggested not to be regulated as medical devices, 4 products were suggested to be regulated as drug-device combination products, 2 products were suggested to be managed on the specific situation, and 15 products were suggested not to be regulated as medical devices alone.

If your products are not listed in the Medical Device Catalogue of NMPA, the application of category classification to NMPA is a good solution to identify the class of your device. We do highly recommend to map out your strategy to enter China before you kicks off the registration, including digging out the category of your device in China. Sometime, if your product is Class II in US, but it may be regulated as Class III in China. BradyKnows elite team is very knowledgeable about the classification of medical device products, if you have any questions about this, please contact info@bradyknowsmedical.com.