In response to the novel Coronavirus (COVID-19) outbreak, China NMPA (formerly the CFDA) issued over 70 emergency approvals of medical devices, diagnostic assays, protective supplies and sterilization tools. The first batch of diagnostic assays were approved in five days.
The COVID-19 crisis has rapidly spread outside of China and is severely impacting the global economy. There are lessons to be learned from China – whether that is through emergency approval pathways or emergency importations without approval from the country of origin.
This webinar explains the related guidelines, emergency approval procedures and urgent importations, as well as how these work in practice and what’s needed during and after the crisis. Join us for this informative session to see whether and how these changes will impact your market entries in China – the world’s largest life science market.
Topics will cover NMPA regulatory updates and China’s current market situations impacting manufacturers of medical devices and IVDs.
Upon conclusion of the program, you will be able to:
- Find out which products have gotten the latest emergency approval from NMPA due to COVID-19
- Familiarize yourself with key pathways, requirements and relevant regulations for emergency approval from NMPA
- Discover urgently needed products: AI, Diagnostics, ICU Care, Imaging, etc.
- Understand the key implications to your China entry strategy moving forward