The up-to-dated version of the Medical Device Classification Catalogue is still in progress.
This document is intended to identify the category of the medical device and, consequently, the applicable class and registration procedure by the CFDA.
The Medical Devices are diveded into categories according to their intended use and clinical application. Also the structure of the document facilitates the integration of new Medical Devices into categories.
22 different device categories have been identified and splitted in types and sub-types.
At the end of the reviewing process, the Catalogue will go beyond some deficiencies present in the previous version, i.e. difficulties classifying Medical Devices and lacking of consideration of technologically advanced and innovative devices.
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