Quality Track B: In the post-Covid-19 Era，how manufacturers integrate QMS to  demonstrate the compliance to overseas jurisdiction medical device authorities

Introduction

Agenda

MDiT Forum and Regulation Summit 2021—— Quality Track B: In the post-Covid-19 Era，how manufacturers integrate QMS to  demonstrate the compliance to overseas jurisdiction medical device authorities

Afternoon of Dec 21| Conference Room6 , B2 of SWEECC

Co-organizers: Medtec China

Introduction

Conference Background:

At the year of 2020, an epidemic caused by a virus known as COVID-19 quickly swept the whole world. Due to the inadequacy of medical device, all the countries must increase the storage of protective medical devices and ICU relevant devices.
Affected by the epidemic, demand for medical devices such as protective clothing and masks soared, as did demand for devices including POCT testing reagents for the IVD industry, nucleic acid extraction devices, gene sequencing technology, medical imaging devices such as CT scanners; monitoring devices such as ECG monitors and blood gas analyzers; ICU products such as ventilators and masks, and ECMO; and medical robots. Therefore, new regulations were released to speed up the medical device approval process, while the authorities are working to improve production capacity for medical devices and ensure stable supply.
In response to the COVID-19 outbreak, the medical device regulatory authorities of all the countries introduced more convenient access policies for medical devices during the outbreak response, for example, the EUA of the United States, the EUL of the WHO purchased by the United Nations and the MDR of the European Union were extended.
The meeting to be held will focus on how for enterprises to meet the regulatory and quality control requirements of epidemic prevention supplies in the countries where they are used in response to the epidemic, and share the practical experience of Chinese manufacturers in dealing with the requirements of post-market quality system in countries and regions under different jurisdictions.

Who Should Attend?

Medical device manufacturers: heads of export sales, regulatory, quality, production and R&D departments and projects / enterprises
Regulatory consulting, research and service companies on medical devices
Regulatory authorities and scientific research institutions of medical devices

*Conference agenda updates according to speaker confirming.

Agenda

>> Medtec China 2021 MDiT Forum and Regulation Summit

Speaker

LCDR Scott C. Gonzalez, FDA International Program and Policy Analyst - Medical Devices, China Office
Zeli Yu, RAC GLOBAL

Conference Room of Shanghai World Expo Exhibition & Convention Center

North Entrance, No. 850 Bocheng Rd. Shanghai