Introduction

Agenda

Speaker

Sponsor/Package

Registration

Transportation

Sino-foreign Medical Device Policies and Regulations Forum

organizers: Medtec China

Conference Background:

• On March 18, 2021, the State Council issued the newly revised Regulations for the Supervision and Administration of Medical Devices, which created favorable conditions for China’s medical device industry and marked a new stage of legal supervision over medical device in China.
• With the promulgation and implementation of the new version of Regulations for the Supervision and Administration of Medical Devices, supporting rules and documents have been revised and issued, and a new regulatory system for registration management has been built. Regulatory establishment, review and approval of medical device innovation, and premarket and postmarket supervision remain the focus of domestic regulations.
• On European Time July 17, European Union issued the Factsheet for authorities in non-EU/EEA states on medical devices and in vitro diagnostic medical devices, which specifically describes the relevant matters of MDR/IVDR transitional revision and applies to the references and visits of competent authorities, customs and distributors in non-EU and non-EEA economic zones.
• Devices urgently approved in the COVID-19 period by FDA will gradually transit to routine regulation after May 11, and FDA regulatory policies need to be understood for products exported to the United States.

Who Should Attend?

• Medical Device Manufacturer: Head of Regulatory, Quality, Compliance, Medical, R & D and Project/Enterprise
• Medical Device Regulatory Consulting, Research and Service Companies
• Medical Device Supervision Authorities and Scientific Research Institutions

*Conference agenda updates according to speaker confirming.

.

>> Medtec Innovation Forum 2023 Conference and Event Agenda

Lanming Wang    Professor Researcher, Senior Expert in Medical Device Regulation

Wei Xu, Former Deputy Director of the Medical Device Evaluation Center, National Medical Products Administration

Chunxia Li    Director, Laboratory of Medical Equipment Reliability, Institute of Integrated economy, and Technology of Mechanical Industry Instrument

Shaomeng Chen, PhD, Referral Ambassador, Zhuhai Investment Promotion Office

Simin Li, Deputy General Manager, Investment Promotion Service Department of Zhuhai Jinqin Health Technology Co., Ltd.

Chen Yuan    UDI Project leader, Healthcare Division, Zhongguancun Industry & Information Research Institute of Two-Dimensional  Code Technology

Zhifang Wang    Deputy Director, Guangdong Institute of Advanced Biomaterials and Medical Devices,   Transformation Center

Baogang Qu, General Manager , Beijing Bioray Medical Technology Co., Ltd.,

                        Expert Reviewer , Center for Medical Device Evaluation . NMPA

>> Sponsor Package

>> Registration