Regulation Track A: Chinese Regulatory Updates and Compliance

Regulation Track: Chinese Regulatory Updates and Compliance

Introduction

MDiT Forum and Regulation Summit 2020-

Regulation Track: Chinese Regulatory Updates and Compliance

Sep 14, 2020 | Conference Room 3 , B2 of SWEECC

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,Development trend outlook of Chinese medical device industry
>2,The procedure、registration and supervison key point under Listing Permit Holder System in China and the questions 、 slutions met during practical registration
>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
>6,Disscussion on standard of Molecular diagnosis reagent industry

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