Quality Track B: Key Points and Strategy for Inspection

Quality Track B:Key Points and Strategy for Inspection

Medtec China 2019 onsite: MDiT Forum and Regulation Summit 2019

Quality Track B: Key Points and Strategy for Inspection

Afternoon of Sep 26, 2019 | Conference Room X, B2 of SWEECC

Organizers: Medtec China

Conference Background

Overseas inspection is one of supervision method in medical device industry, which could help the manufacturers abroad compliance Chinese regulation on quality system. Chinese regulatory bodies started the overseas inspection from the year 2015, and the quantity for inspection has been reached 26 in 2018. What’s more, the requirement has been improved and the scope has been expanded

FDA factory inspection is one of the strictest review modes in medical device quality management system. For the manufacturer who is going to or just wants to entry into US medical device market, to complete FDA inspection cooperating with FDA inspectors utilizing QSIT is very important to accelerate product appearing on US market.
This track will explore the different requirements for inspection from Chinese regulatory bodies and FDA, as well as the coping strategies. The content will help domestic and foreign medical device manufacturers to comply with the quality management regulations, and avoid risks and Promote product sales.

Conference Content