Chinese Medical Device Registration Update.pdfVIP

Suite 408, 460 Pacific Hwy St Leonards BRANDWOOD :BIOMEDICAL NSW 2065 Australia securing your compliance Office: +61 (0) 2 9906 2984 Fax: +61 (0) 2 8580 4613 enquiries@.au Chinese Medical Device Registration Update –SFDA introduces 96 new Industrial Standards Han (Davey) De Hui and Xiao (Lucy) Yan Zhu 8 February 2011 China has introduced 96 new Industrial Standards in December 2010, to be implemented from 1st June, 2012. The seventh article in the Provision on Medical Device Registration (2004) (医疗器械注册管理办法) specifies that all medical device manufacturers are required to submit evidence of compliance to product standards that are equal or more stringent than their respective National or Industrial Standards for registration in China. The competent body in China, the State Food and Drug Authority (SFDA), has its unique procedures and guidelines for registration of medical products. A Product Standard Dossier (产品标准) which is broadly equivalent to a Summary Technical File. The Dossier must include evidence of compliance with Chinese National Industrial Standards is mandatory and it is the manufacturer’s assurance for each product’s function and safety. Certification to International standards such as ISO and IEC are not automatically recognised by SFDA. There are three levels of standards adopted by SFDA; the National Standards (国家标准), the Industrial Standards (工业标准) and the Enterprise Standards (企业标准). Only when