Introduction

Agenda

Speaker

Sponsor/Package

Registration

Transportation

Medtec China 2018 onsite: MDiT Forum and Regulation Summit 2018

Regulation Track B: US & EU Regulatory Updates and Market Access

Afternoon of Sep 27 |  B2#4

Organizer: Medtec China

Introduction

Conference Target

•     Hearing authoritative foreign trade report on medical device import and export

•     Learning overseas market access strategy

•     Seeking for sally port in export trade development

Conference Background

• With the rapid development of Chinese medical device manufacturing, more and more competitive products export to US, EU and other area around the world. Therefore, the local regulation compliance and certification is very important for them.

• In US-FDA, 510(k) and registration & listing are most important pre-market regulations for medical device; Along with the formal effective of the latest MDR and IVDR from May 2017 in EU, a series of requirements of product classification, clinical supervision and post-market tracking will be increased. This conference will focus on the hot topics in US and EU regulation updates and providing compliance solution for device manufacturers who wants to export to these market.

Main Topic

• Perspective of FDA: Medical Device Registration and Listing: Important Reminders about R&L
• How to support product registration with foreign clinical data, from China to US and from US to China
• How to do Quality Control to apply 510 K easily
• EU MDR & IVDR implications for device manufacturers & suppliers

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

>> Download

Speaker

Coming soon

Sponsor/Package

Registration

>> Register now

Transportation

Conference Room of Shanghai World Expo Exhibition & Convention Center

North Entrance, No. 850 Bocheng Rd. Shanghai

Hotel Reservation