Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
China’s State Order 739 has brought continuous change in regulatory, clinical, and commercial affairs this year. But as the only country with double-digit growth in MedTech, China cannot be ignored just because its market-entry submission process is challenging.
In this strategic program, we will review key policies, guidelines, and standards, and look ahead to 2023. Attendees will identify techniques manufacturers and inventors can implement to shorten their time to market. They’ll also discuss PTR tests, standards’ changes, post-market compliance inspections, and penalties. And we haven’t forgotten the emerging “made-in -China” policies.
Free
After this program, participants will be able to:
Basic: Content is introductory and doesn’t require prior knowledge or experience. Basic educational activities will build a foundation of knowledge and/or competence that can be expanded upon in practice or through higher-level activities.
Instructors:
Grace Fu Palma
Grace Fu Palma is the founder and CEO of China Med Device, LLC (www.ChinaMedDevice.com) with offices in Beijing and Boston providing one-stop solutions for western medical device/IVD companies to enter China with regulatory, clinical affairs and commercialization services. Our accomplishments: 500+ certificates, and 250+ Chinese and western companies’ success. She is a seasoned bilingual and bicultural MedTech executive, who specializes in China NMPA (formerly CFDA) regulatory and commercialization services, with 20+ years of experience driving global and China business strategy, regulatory and clinical affairs, commercialization, and partnerships, for both large multinationals and startup companies. She has been a regulator speaker on China regulatory, clinical affairs, and market access subjects at key national and local MedTech meetings, and contributed to multiple industry and regulatory journals, Medtech News, etc. She also founded the Chinese American Heart Association (CnAHA) in 2005, a leading Chinese cardiovascular clinicians society with members and presence in both China and The US. Grace grew up in Beijing, China, and received a BA/BS joint degree from Peking University, China, and an MBA from Yale University in New Haven, CT.
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.
All cancellation requests must be submitted in writing to raps@raps.org. RAPS is unable to accept cancellations by phone.
To transfer a registration, email raps@raps.org with the event title, name of the original registrant and the contact information for the new attendee.
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshop: https://www.raps.org/website/virtual-event-helpFor account support, contact the RAPS Support Center: +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.