The Current Status and Suggestions of Registration Quality System Audit for Entrusted Production According to Shanghai Medical Device Regulation of Marketing Authorization Holder

This study expounds the current status of registration quality system audit for entrusted production in the last three years, according to shanghai medical device regulation of marketing authorization holder（MAH）, by typical non-conformity sorting and analyzing, main responsibilities of the registrant highlighting, relevant parties’ obligations and rights clearing. Meanwhile, it also provides a certain level of useful reference for medical device Marketing Authorization Holders and relevant regulators.