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

26-28 September 2018 | Shanghai,China

Regulation Track A: Chinese Regulatory Updates and Compliance

Introduction

Agenda

Speaker

Sponsor/Package

Registration

Transportation

 

Medtec China 2018 onsite: MDiT Forum and Regulation Summit 2018

Regulation Track A: Chinese Regulatory Updates and Compliance

Sep 26 | B2#3

Organizer: Medtec China

 

Introduction

 

Conference Background

There was frequent update of Chinese medical device policy and regulations during 2017 to 2018 and lot of new policy and principles were launched by CFDA and CMDE. Multiple areas were covering from aspects of approval speed up, encourage innovation, registration improvement, clinical management and technology increase.

There are a series of challenges and opportunities for medical device manufacturers, suppliers and the whole medical system in the background of regulation changes. How to response the updates quickly, how to improve product efficiency and how to speed up the R&D and market transformation has become the important proposition for them.

Medtec organizes Chinese Regulation Conference Track every year to provide the latest regulatory information and compliance strategy for manufacturers, and to help them develop in complicated market. .

 

Main Topics

>How to improve Quality through unanounced inspection

>The contents and requirements of database in UDI

>Perspective of final user: Medical Device Registration and Listing

>The interpretation and implementation of the medical device registration system

>Key points for the implementation of clinical trial quality management of medical device in China

>Regulation challenges and risks for company when actualize UDI

>Clinical trial design of medical device complying with the updated regulation


Who Should Attend?

>Registration, QA&QC, Compliance, Medicine, 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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Transportation

 

Conference Room of Shanghai World Expo Exhibition & Convention Center

North Entrance, No. 850 Bocheng Rd. Shanghai

Hotel Reservation

 

Speech & Cooperation

Carina Li

T:+86-10-5730 6163

E:carina.li@ubm.com

Sponsor & Paid Conference

Julia Zhu

+86-21 6157 3922

E:julia.zhu@ubm.com

Media & Free Conference

Sophia XU

T:+86-10-5730 6095

E:Sophia.xu@ubm.com