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CFDA: Article Regarding the Updated Regulations Required for CFDA Approval Published in “China Contact” Magazine

9. November 2014

Mr. Julian Busch CEO of MPR China Certification GmbH / China Certification Corporation recently wrote an article regarding the CFDA approval of medical devices in China. This article was published in the November 2014 issue in the magazine “China Contact”.

The short article covers the general import regulations, which are mandatory for the legal import and disposal of certain medical devices for the Chinese market. In recent years, the Chinese regulators have placed more emphasis on the importance on product safety of medical devices. In 2013 the CFDA (China Food and Drug Administration) catalog stating which products require approval, was re-written with many more products being added. In March of 2014 new “Regulations for the Supervision and Administration of Medical Devices” were published, which became effective in June of 2014.
20141109112352247The article describes the updates and how they must be implemented. You can find the article here on our website (in German language).

Julian Busch has published numerous articles regarding the CFDA approval of medical devices for the Chinese market. Besides CFDA publications, he has also published articles regarding the CCC certification for products. A complete list of publications can be found here.

We will inform you about all of our upcoming publications and new released announcements of Chinese authorities in the “News” and “Media and Publications” section on our website.

If you want to learn more about CFDA certification for medical devices and products, please visit the CFDA section on our website. We also provide more detailed knowledge regarding CFDA in our free brochure “CFDA China – The Booklet” that can be downloaded here.

If you have any questions, please contact us by phone (UK: +44 2071931135, Rest of Europe: +49 69 2713769150, US: +1 773 654-2673) or email.


MPR Author

About the author: Julian Busch is founder and managing director of MPR China Certification GmbH
Publisher: MPR China Certification GmbH

Tel.: +49 69 271 37 69 150