In response to the novel Coronavirus (COVID-19) outbreak, China NMPA (formerly the CFDA) issued an unprecedented amount of 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 regulatory and clinical 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, clinical trial conduct, quality assurance 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, as well as the impact on clinical trials and quality assurance
- Discover urgently needed products in the COVID-19 patient care cycle: AI, Diagnostics, ICU Care, Imaging, etc.
- Understand the key implications to your China entry strategy moving forward
Meet the Speakers:
Grace Fu Palma, MBA
CEO, China Med Device, LLC
Grace brings 20+ years of MedTech industry experience. She is the CEO of China Med Device, LLC (www.ChinaMedDevice.com) a MedTech consulting firm specializing in China market access, with offices in Boston and Beijing, offers regulatory strategy, registration, type testing, CER, full service CRO, compliance, PMS and related services. The company has processed 1,000+ CFDA certificates, 250+ Chinese and western companies’ success. A seasoned bilingual and bicultural MedTech executive, she held a variety of marketing, operational and strategic development management positions at both large multinationals (Hewlett Packard Medical) and startup companies (Teratech). She specializes in China NMPA (CFDA) regulatory (RA/QA/CRO/CER) and commercialization services. In addition, she founded the Chinese American Heart Association (500+ cardiovascular clinical professionals) in 2005. She is a regular speaker at key national and local MedTech meetings, frequent contributing writer to multiple journals, FDA News, RAPS Forum and Medtech New. Grace grew up in Beijing, China and received a BA degree from Peking University, China, and an MBA from Yale University in New Haven, CT.
Yan Sheng, PhD
Project Manager, China Med Device, LLC
Yan Sheng, PhD, is the project manager of China Med Device. She grew up in China with many years of working experience in the life science industry in both US and China. She received her bachelor’s degree in pharmaceutical science in China and PhD at Oregon State University in the US. Her PhD studies focused on natural products discovery from microbial world. With more than six years’ experience in academia, she is familiar with cutting edge technologies in the latest developments in the diagnostic and companion diagnostic life science industry.