CFDA: Article Regarding the Certification of Medical Devices in China, Published in “In Compliance” Magazine9. September 2015
Mr. Julian Busch CEO of MPR China Certification GmbH / China Certification Corporation recently wrote an article regarding the Certification of medical devices in China. This article was published August 31, 2015 in the magazine “In Compliance” online.
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 that shows which products require prior approval, was revised with many more products being added. In March of 2014 a new “Regulations for the Supervision and Administration of Medical Devices” was published, which became effective June of 2014.
The article describes the updates and how they must be implemented. You can find the article here.
Julian Busch has published numerous articles regarding the CFDA certification and 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.
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