Introduction

Agenda

Speaker

Sponsor/Package

Registration

Transportation

MDiT Forum and Regulation Summit 2020-

Regulation Track: Chinese Regulatory Updates and Compliance

Morning of Sep 14 | Conference Room 3

Organizer: Medtec China

Introduction

Conference Background

• The COVID-19 pneumonia in 2020, as a public health emergency of international concern, has caused broad attention to the medical industry. What is the future of the medical device industry? In 2018-2019, regulators enacted a large number of new regulations and guiding principles. Now we are about to interpret the associated hotspots.
• On August 1, 2019, the National Medical Products Administration (NMPA) issued the Notice on Expanding the Pilot of the Medical Device Registrant System. Based upon the preliminary pilot work of the medical device registrant system in Shanghai, Guangdong and Tianjin free trade zones, the notice aimed at expanding the pilot of the medical device registrant system to 21 provinces (autonomous regions, municipalities), including Shanghai, Guangdong, Tianjin, Beijing, and Hunan, to gather further experience for practicing the medical device registrant system across the country and accelerate the innovative development of the medical device industry. It will certainly do good to enterprises of all kinds in the medical device industry.
• Molecular diagnostics is considered the most active field of research and development in the IVD industry. There are a variety of reagents and products in the field of molecular diagnostics, and as the number grow increasingly bigger, standards appear relatively lagging. To meet the need of industry regulation, China should accelerate the enaction and revision of national and industrial standards in the molecular diagnostics field.

Main Topics

• >1,The supervision of Medical devices in 2019 and the key points of supervision in 2020
• >2,The latest progress and regulatory focus under the Listing Permit Holder System
• >3,Medical Device e-registration workflow、tips and experience sharing
• >4,latest process of specail inspection of Innovative Medical Devices
• >5,Application of clinical trial data in Clinical Appraisal of Medical Devices

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 the agenda of MEDTEC China 2020

Speaker

Baoting Wang，Deputy Secretary-General, China Society of Pharmaceutical Supervision and Administration

Lin Feng，Commissioner，Division of Medical Devices Registration, Shanghai Medical Products Administration

Alex Jiang, Smith & Nephew

Xiaoming Feng, Vice Director, Biomaterials and Tissue Engineering Division NIFDC

Yin Lu, Chief Director, Evidence-based Medicine Medical Research & Biometrics Center National Center for Cardiovascular DiseasesComplete guest Introduction Download

Sponsor/Package

>> Sponsor Package

Registration

>> Register now

Transportation

Conference Room of Shanghai World Expo Exhibition & Convention Center

North Entrance, No. 850 Bocheng Rd. Shanghai

Hotel Reservation