Regulatory Open Forum

Recently, I have noticed a lot of people asking us about China Medical Device Classification Catalog. I thought the following may be helpful.

NMPA (CFDA) Medical Device Classification Catalog (draft) was published August 31, 2017.  A year later, it became effective on August 1, 2018. New registration application after August 1, should follow the new classifications. After the release of the initial Catalog in 2002, NMPA has made several modifications to standardize the classification and streamline the registration process. The new Catalog is the result of several years efforts.

The new Catalog specifies that "classifications should be based on the Device Category, Subcategory, Example of Device Names, Product Description and Intended Use." Compared with the previous catalog, key changes are:

1. The number of device categories decreased from 43 to 22.
2. 1,157 subcategories are added. For example, Magnetic Resonance Imaging (MRI) machine has 3 subcategories: closed bore (cylindrical), open bore, and dipolar electromagnet configuration.
3. Product description and intended are added to determine the classification. The difference between sterilized device and non-sterilized one, under same category and subcategory, are shown in the product description.
4. More examples of device names are provided. The number of device names increased from 1,008 to 6,609.
5. 40 reclassifications.
6. Included AI diagnostics for the 1st time.

IVDs and Companion Diagnostics are not included in the new medical device Catalog.

 

I'd love to hear about anyone's experience with the Medical Device Classification Catalog. If you have any questions or want more information, feel free to send me a message or email at gpalma@ChinaMedDevice.com.

 

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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com
978-390-4453
www.ChinaMedDevice.com
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