Introduction

Agenda

Speaker

Sponsor/Package

Registration

Transportation

The 2nd Edition of Regulatory Lecture: Best Practice for Product Compliance and Market Launch

Sep 26, 2019 | Conference Room B, Hall 2 of SWEECC

Organizers: Medtec China

Conference Target

• Exploring the key regulations and compliance strategy of medical device industry
• Looking for approaches to speed up the launch of medical devices
• Jointly promote the innovation and development of medical device products
• To provide a platform for medical device regulatory engineers for interaction and communication cooperating with the exhibition

Conference content

• Regulation updates of FDA in 2018 and the BDP plan
• How to prepare for MDR and IVDR for medical device manufacturers
• The relationship among manufacturers, suppliers and Notified Body in the new EU regulations
• How to implement ISO 9001: 2015 and ISO 13485: 2016
• Comparison of US market access regulations: 510K, De Novo, and PMA
• Updates of MDSAP
• Experience of UDI in US and the implementation progress in China

Who Should Attend?

• Registration, QA&QC, Compliance, Medicine, R&D Department, Project Manager/Director and Managing Director from medical device manufacturers

• Surveillance organization and research institution

• Regulation, testing, certification, verification, clinical trials and other services suppliers

>> Download

Coming soon

>>Register now

Conference Room of Shanghai World Expo Exhibition & Convention Center

North Entrance, No. 850 Bocheng Rd. Shanghai

Hotel Reservation