New Batch Of China Medical Device Catalogue Modification

On Dec 27, 2021, Center for Medical Device Standardization Administration of NMPA published a notice to collect public comments on China Medical Device Catalogue. Any feedback needs to be submitted by January 24, 2022.

Center for Medical Device Standardization Administration is an institution of NMPA to be responsible for standard research and also do medical device classification.   

As a fundamental guideline for China registration, Medical Device Catalogue is going to take a second-batch modification by NMPA. In this modification, some devices for neurological and cardiovascular surgery will be lowered down as Class II medical devices instead of Class III.

In addition, some of the new products are included as the classification examples, which will provide a clearer and more specific instruction during the registration.

It is a great opportunity to have your voices heard by NMPA reviewers and influence them to form a more practical guideline in the end. A thorough and realistic guidance document not only helps NMPA reviewers during their technical review process but also guides manufacturers to satisfy NMPA’s requirements.

For more information about how to develop a feedback strategy or assistance in submitting your inputs, please contact info@inspirativemed.com.