CFDA: CFDA Issues Rules for Classification of Medical Devices

20. August 2015

Certain medical products and devices are required to have prior approval by the CFDA (China Food and Drug Administration Chinese: 国家食品药品监督管理总局) before they can be imported, bought, sold, traded or used in China. In an effort to insure continued safety and effectiveness of medical products there have been ongoing changes and revisions within the Chinese regulatory framework for CFDA certification.

The CFDA recently issued the Rules for Classification of Medical Devices (Order No. 15), which will be implemented as of January 1, 2016.

The new order discusses how risk-based classification of medical devices will be used not only for registration but also for device production and supervision. This includes revisions and clarifications to classifications, terms, and definitions of medical products and devices.

It can be difficult for medical device manufacturers to determine if their products will require certification, and if so, in which classification their products should be categorized.

A complete evaluation of CFDA-responsibility and classification simplifies your registration process and prevents additional, unplanned costs.

If you have any questions or concerns, please do not hesitate to Email or call us: Germany: +49 69 271 3769 150, UK: +44 2071931135, US: +1 773 654 2673