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Medtec China 2020 onsite: MDiT Forum and Regulation Summit 2020

Morning of Sep 15 |  Conference Room 3

Organizers: Medtec China

Conference Background

• At the start of 2020, an epidemic caused by a virus known as COVID-19 quickly swept the whole world, and it is still carrying on. To avoid the run on medical resources and save lives in the context of insufficient medical equipment reserves and tight time, all the countries in the world need to need to increase the stock of basic medical supplies and ICU products, and invest heavily in test reagents for virus screening
• At the start of 2020, an epidemic caused by a virus known as COVID-19 quickly swept the whole world, and it is still carrying on. 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

Conference Content

• How to be included in the US emergency use approvals: the difference between applying for FDA EUA and 510 (K)
• How to be included in the UN Procurement suppliers: application for EUL of the WHO
• Post-market management of epidemic prevention supplies by European and American authorities after the launch of EUA and EUL
• Impact of MDR extension for one year on epidemic prevention device manufacturers

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.

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Zeli Yu RAC Global

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North Entrance, No. 850 Bocheng Rd. Shanghai

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