中国国际医疗器械设计与制造技术展览会(Medtec China)2018

Dedicated to design & manufacturing for medical device

25-27 September 2019 | Shanghai,China

Quality Track B:Key Points and Strategy for Inspection

Introduction

Agenda

Speaker

Sponsor/Package

Registration

Transportation

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

Introduction  

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

  • Key points summary of overseas inspection from Chinese regulatory bodies
  • How to prepare the overseas inspection for manufacturers
  • FDA inspection, what’s new in 2018 and 2019?
  • How to reply the FDA inspection for device manufacturers

Who Should Attend?

  • Registration, QA&QC, Compliance, Manufacturing, R&D Department, Project Manager/Director and Managing Director from medical device manufacturers
  • Regulation and Research Service Suppliers and Consulting
  • Surveillance Organization and Research Institution

*Conference agenda updates according to speaker confirming.

Agenda  

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Speaker
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Sponsor/Package  

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Registration  

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Transportation  

Conference Room of Shanghai World Expo Exhibition & Convention Center

North Entrance, No. 850 Bocheng Rd. Shanghai

Hotel Reservation 

Conference Inquiries

Speech & Cooperation

Carina Li

+86-10-57652823

E : carina.li@ubm.com

Sponsor & Paid Conference

Julia Zhu

+86-21 6157 3922

E:Julia.zhu@ubm.com

Media & Free Conference

Sophia XU

+86-10 5767 2825

E:Sophia.xu@ubm.com