Medical Device Clinical Trials in China – Webinar Recording/Transcript
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Want to reduce your device’s clinical trial costs and accelerate its time to market in China? It’s possible when you use the latest China National Medical Products Administration (NMPA) regulatory developments to your advantage.
Now more than ever, NMPA’s regulatory approval process is going through transformational reform. Devicemakers — especially non-China manufacturers — have more options to supplement the traditional comprehensive clinical trial.
Case in point: for the first time, a class III implant device was approved in China without the traditional clinical trial. Its manufacturer did so in just a few months using a real-world study of a small sample size.
How? An evolution in real-world data/evidence (RWD/E) over the past year. This implant approval demonstrated that initial clinical use in real-world settings can take place in months, not years for NMPA-unapproved devices.
Savvy devicemakers are using the latest regulatory developments to lower clinical trial costs and accelerate time to market. They’re drawing on key factors for China’s clinical strategy and pathways to support their submissions, updates on the RWD pilot program, while considering crucial elements in using overseas clinical data.
And you can, too.
In this presentation, Grace Fu Palma, CEO of China Med Device, LLC and Jason Zhang, MD, its Clinical Director, will share what you must know and use to do just that.
- Different clinical pathways and how to decide which pathway to choose to support the NMPA medical device/in vitro diagnostic (IVD) regulatory submission or postmarket surveillance
- Key areas you need to pay attention to so as to have the right strategy and tactics to shorten clinical trials and approval times
- Find out whether your devices qualify for the real-world data/study Hainan program, and how to get into the program
- Key considerations on the feasibility and justification of overseas clinical data acceptance
- Strategies to improve the overall contract research organization (CRO) process and get your new products to the Chinese population faster — clinical trial study design and clinical trial protocol, calculation of sample size, on-site management and data integrity
Once you understand these regulatory developments, you’ll reduce your clinical trial costs and get your devices to the Chinese market faster. Join us by registering today.
Meet Your Presenters
Grace Fu Palma, CEO of China Med Device, LLC, a seasoned medtech executive who specializes in accelerating U.S. medical device companies’ entry and growth in China with regulatory and commercialization services. With 20+ years of experience driving global product strategy, commercialization, partnerships, and China operations for both large multinationals and startup companies, she held a variety of management positions in marketing and operations at multinationals and start-ups. She founded China Med Device, LLC (CMD) in 2011. CMD (www.ChinaMedDevice.com) helps medical devices & IVD companies with turnkey commercialization services from market assessment, regulatory (premarket approval, legal representation, clinical evaluation, clinical trial, and postmarket), to distribution management in China. With an office in Beijing and an office in Boston, CMD provides 24/7 CFDA regulatory consultation services from pre-market submission to postmarket surveillance to accommodate the difference between the East and West.
Jason Zhang, MD, has 10+ year clinical trial and management experience in China. With his expertise in clinical design, data quality in CRC and CRA, reporting and evaluation, Jason has managed the clinical trial for oncology positioning system, ultrasound, MRI and CT and other diagnostic products. He designed and completed the clinical trial for the 1st domestic Linear Accelerator in China with 75 patients in less than a year. It was approved by CFDA through Innovation Device pathway. He is also a patent owner at Philips and has several publications on MRI guided HIFU.
Who Will Benefit
- Clinical Affairs Professionals
- Regulatory Affairs Professionals
- Product Managers
- Quality Professionals
- Compliance Professionals
- Inspection and Audit Professionals
- R&D Managers, Directors and Vice Presidents
- Marketing Managers, Directors and Vice Presidents
- C-Level Executives: Chief Marketing Officers, CEOs, COOs
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Dec. 10, 2020