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

Abstract

This study expounds on the current status of the registration quality system audit for entrusted production in the past three years in accordance with Shanghai's medical device regulations for marketing authorization holders (MAH). Through sorting and analyzing typical non-conformities, highlighting the main responsibilities of registrants, and clarifying the obligations and rights of relevant parties. Meanwhile, it also provides a certain useful reference for medical device marketing authorization holders and relevant regulators.

Keywords

• marketing authorization holder
• entrusted production
• registration quality system audit
• non-conformity