NMPA Proposes to Expand the Scope for the Class I Medical Device Classification Catalogue

On August 18, 2021, the NMPA (National Medical Products Administration) released the revised draft of the Class I Medical Device Classification Catalogue to solicit public comments.

Apart from the Medical Device Classification Catalogue that was published by the State Food and Drug Administration (former NMPA) in 2017, there are different documents that can be referred to for the classification and product definition of class I medical devices, including the Class I Medical Device Classification Catalogue.

Due to the emergence of new technologies, products and materials in the medical device industry over the past years, the NMPA added 600 new product examples in the proposed catalogue to cover a total of 2689 products.

Highlights

Features of the new proposed Class I Classification Catalogue:

• Same framework as the 2017 version

• Retention of product information in principle for Class I medical devices under five specific product categories from the 2017 version

• The names of the 600 new product examples added to the proposed catalogue that also comply with the NMPA Guidelines for Nomenclature for Common Names of Medical Devices

• The proposed catalogue no longer includes IVDs and combination products

• A list of prohibited ingredients for Class I medical device products was added in the appendix

By Nina Yan. Contact Cisema if you would like to learn more.