Quality Track B: FDA's Shift from 21 CFR 820 Toward ISO 13485：2016 and FDA factory inspection

Quality Track B:MDSAP under MDR and overseas QMI of China and FDA

Medtec China 2019 onsite: MDiT Forum and Regulation Summit 2019

Quality Track B: KMDSAP under MDR and overseas QMI of China and FDA

Morning of Sep 26, 2019 | B2 of SWEECC Conference Room 6

Organizers: Medtec China

Conference Background

• China NMPA Overseas Inspection focuses on the manufacturers post marketing activity, it is the action that China Authority NMPA increase the enforcement of oversea medical device manufacturers compliance to China regulation besides the pre marketing approval but also the post marketing compliance on quality system establishment. China regulatory body started the overseas inspection from the year 2015, and the quantity for inspection has been reached more than 40 manufacturers in EU and US in 2018. What’s more, the requirement has been improved and the scope has been expanded
• FDA Factory inspection is one of the strictest Quality System Inspection Model in medical device field. For the manufacturer who is going to or just wants to launch the medical device in US market, understanding US regulation insight and facilitate the FDA inspector to accomplish their routine QSIT inspection is the key to knock the door and maintain the door open for the manufacturer’s product in the US market.
• EU MDR will be launched in May. 2020, how it would impact the MDSAP audit?
• This track will explore the different requirements for inspection from China regulatory body NMPA and US FDA, as well as the inspection strategies. The content will help domestic and foreign medical device manufacturers to comply with the quality management regulations and avoid violations and ensure the device safety and effectiveness.

Conference Content