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CFDA Updates Classification Catalogue of Medical Devices

Applicants registering medical devices will be required from 1 August 2018 to submit their applications according to the requirements stipulated in the updated Classification Catalogue of Medical Devices, according to the China Food and Drug Administration (CFDA).

The new catalogue divides medical devices into 22 sub-categories according to their technical specialty and clinical use characteristics. Medical devices are classified into Class 1 and Class 2 products according to their product description, intended use, product name examples, and management category. It stipulates that the actual condition of the products as well as their description, intended use and product name examples shown in the new catalogue must be comprehensively taken into consideration when determining the management category of the products.

Applications for the renewal of registration accepted and approved before 1 August 2018 will be issued registration certificates by the food and drug administration department according to its original category.

For further details (in Chinese), please refer to the following website of the CFDA:

Circular on Matters Concerning the Implementation of the Classification Catalogue of Medical Devices (No. 143, 2017)

Announcement of the Classification Catalogue of Medical Devices (No. 104, 2017)

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