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: MDSAP updates and FDA Inspection

Introduction

Agenda

Speaker

Sponsor/Package

Registration

Transportation

Medtec China 2018 onsite: MDiT Forum and Regulation Summit 2018

Quality Track B: MDSAP updates and FDA Inspection

Morning, Sep 27 | B2#3

Organizers: Medtec China

Introduction  

Conference Background

  • There were 104 flight inspection from CFDA in the year of 2017 and 76 medical device manufacturers were inspected. (Data from CFDA) At the same time CFDA overseas flight inspection is increasing in both range and frequency in 2017, overseas manufacturers should be inspected from two sides of FDA and CFDA.
  • FDA factory inspection is one of the strictest review mode 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. Exploring FDA regulation on post-market surveillance and factory inspection systematically and integrally is useful for the manufacturer who is likely to enter into US market. Therefore manufacturers could evaluate the market in depth and formulate their exportation plan reasonably.

Conference Content

  • MDSAP Regulatory Introduction
  • Industrial Practice :How to integrate the MDSAP in your own quality system
  • FDA Industry practice :Experience sharing of FDA inspection during 2017 and 2018
  • Experience sharing of CFDI oversea inspection

Who Should Attend?

  • RA, QA&QC, R&D Department, Project Manager/Director and Managing Director from medical device manufacturers, or manufacturers who (is going to) export to US
  • Other regulation service organization

*Conference agenda updates according to speaker confirming.

Agenda  

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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