New Medical Device Classification Catalog

September 4 2017, China Food and Drug Administration (CFDA) issued the announcement about the new version of ‘Medical device Classification Catalog’. According to the announcement, the new ‘Medical Device Classification Catalog’ will be effective after August 1^st, 2018.

The main content of the ‘New Medical Device Classification Catalog’

The new catalog includes twenty two sub-catalogs based on the medical device technology profession and clinical features
The sub-catalogs consist of first-class product category, secondary product category, product description, intended use, examples and management category.
The product classification determination should be based on the actual situation of the products and also combined with the products' description, intended use and name of the product.

The main feature of the ‘New Medical Device Classification Catalog’

The architecture of the 'New Medical Device Classification Catalog' is more scientific and realistic. It used American clinical use of the classification system and EU Notified Body Structural Catalog as the reference. The New Medical Device Classification Catalog changed from the forty three sub-catalogs in the old version to twenty two sub-catalogs.
The ‘New Medical Device Classification Catalog’ is more extensive, instructional and operational. It is added more than 2000 items of product intended use and product description.
Reasonable adjustment of product management category. According to the product risk level and the actual supervision, 40 kinds of medical device products that have long market time, high product maturity and controllable risk can change to be lower class of management category.

*If you have any comments or questions, please contact us at md@cirs-group.com

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