Publication: New article on new regulations for the CFDA certification published in British professional journal22. April 2014
In the latest publication on the new regulations for the certification of medical devices,
Mr. Julian Busch (managing director of MPR GmbH) outlines the critical changes which are compulsory for new medical device applications at the China Food and Drug Administration (CFDA, Chinese: 国家食品药品监督管理总局). The article is titled “An Update on the Regulatory Process in China” and was published on the April 10, 2014 on the British website “European Medical Device Technology” (abbr. EMDT). This article is in reference to the
CFDA announcement from February 2014 regarding changes for medical devices which have now been officially published.
In order to ensure compliance with the amended regulations for medical devices, the penalties for any delinquency or any non-compliance have been increased. Penalties of up to 20 times the value of the imported goods are possible. Likewise, the Chinese government has implemented the legal basis to remove already certified medical devices from the market on short notice.
In addition to the general discussion of the regulation changes, the article provides a general overview of the CFDA registration process, as well as current and future status of the Chinese medical device market. The article also reflects the historical developments as well organizational and personal changes within the authority CFDA: As a result of several food and corruption scandals the CFDA was put under the supervision of the State Council and reports to the Chinese Ministry of Health (MOH). In the process of restructuration also the name of the body was changed from SFDA (State Food and Drug Administration) to CFDA.