Exemption Order of Clinical Trial Benefiting Thousands of Medical Devices Through Better Allocation of Resources and Industrial Innovation.

  • 2018-10-16

On September 30, National Medical Products Administration issued the revised Catalog of Medical Devices Exempt from Clinical Trials (hereinafter referred to as the new "Exempt Catalog”). Under the Exempt Catalog, a total of 1248 medical devices including medical laser fiber and detection reagent of alpha fetoprotein received the Exemption Order. At the same time, the three previous catalogs were abolished.

Integration and standardization: it is consistent with the new Classified Catalog. The new Exempt Catalog consisted of two ingredients, namely 855 medical devices and 393 in-vitro diagnostic reagents. Of 1090 products listed in the previous catalog, the product name and description of 536 products were standardized, 204 were incorporated into a new catalog or removed from an old catalog and management categories of 83 products were adjusted based on the new Classified Catalog. In addition, products that have been combined with other ones, downgraded to Class Ι or no longer managed as medical devices were removed from the catalog. On this basis, the new Exempt Catalog was created by integrating the previous catalog with the catalog of the new batch of medical devices exempt from clinical trials (including in-vitro diagnostic reagents).

A wider scope: A total of 361 new medical devices were added into the catalog.

Optimizing resources: A greater effort was made to improve the quality of medical devices.