CFDA Mandates New Classification Catalog for Medical Devices

On August 1, 2018, China Food and Drug Administration (CFDA) - the Chinese health authority, has taken a major step towards classification of medical devices to be marketed or currently being marketed in China. The CFDA has officially published and mandated the new Medical Device Classification Catalog. To be on par with continuous changes in regulations for medical devices and considering the innovation taking place in the global life sciences sector, the CFDA has initiated updating their earlier catalog which was published in the year 2002. On August 31, 2017 they even published a draft guidance for the same.

Now, with the mandated version, the CFDA is all set to bring forth the device classification that is based on device category and subcategory. Aiming at a more streamlined structure, the new catalog, as published by an external source, includes below major changes:

• The device categories were decreased in number from 43 to 22 which in effect resulted in reduction of percentage of Class III medical devices

• Eliminated duplicates in sub-categories to add clarity

• Included 1,157 sub-categories to improve the ease of classification

• Product description and the intended use are added to the factors taken into consideration while determining the device classification

• The number of device names provided as examples has been increased from 1,008 to 6,609

• The new classification comprises of a 3-level structure which is more logical and aligns close to the clinical practice

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