CFDA: Article Regarding the Updated Regulations Required for CFDA Approval Published in “China Contact” Magazine
9. November 2014Mr. 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.
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.