Medicine & Medical Devices » Medical device classification catalogue 2018

On September 4, 2017, the State Food and Drug Administration issued the newly revised medical device classification catalogue, which will be implemented from August 1, 2018. In the new catalogue, more than 2000 items of intended use and product descriptions are added, and the number of examples of 1008 items in the current catalogue is expanded to 6609. More than 2000 expected uses and product descriptions of products are added to the new catalogue, and the number of examples of 1008 product names in the current catalogue is expanded to 6609 The new catalogue draws lessons from the clinical application-oriented classification system of the United States and the structure of the framework catalogue for the European Union’s notified bodies, integrates and streamlines it into 22 subdirectories, and refines 260 product categories into 206 first level product categories and 1157 second level product categories, forming a three-level catalogue hierarchy The new classification catalogue does not include in vitro diagnostic reagents, and does not include combined package products. Relevant products have corresponding regulations t