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, CFDA 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:
- The number of device categories decreased from 43 to 22
- 1,157 subcategories are added. For example, Magnetic Resonance Imaging (MRI) machine has 3 subcategories: closed bore (cylindrical), open bore, and dipolar electromagnet configuration.
- 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.
- More examples of device names are provided. The number of device names increased from 1,008 to 6,609.
- 40 reclassifications.
- Included AI diagnostic for the 1st time.
IVDs and Companion Diagnostics are not included in the new medical device Catalog.
For complete version of CFDA Medical Device Catalog, please email info@ChinaMedDevice.com.
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China Med Device, LLC (https://ChinaMedDevice.com) provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, premarket submission, clinical evaluation, CRO, QA and post market compliance. We are experienced in handling innovation approvals and priority reviews. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have offices in Beijing, Suzhou and Boston. Our management team has 100+ years of combined experience in medical device and IVD and has been involved with 1,000+ CFDA certificates and 250+ companies’ success.