RAPS Webcast: 2022 NMPA (CFDA) Key Updates and Look Ahead

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RAC Credits
Virtual ProgramsVirtual Programs
Wednesday, 18 January 2023 (11:00 AM) - Wednesday, 18 January 2023 (12:00 PM) Eastern Time (US & Canada)

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.


REGISTRATION FEES

Free


Learning Objectives

After this program, participants will be able to:

  • Full understanding of State Order 739
  • Leveraging the order to shorten the time-consuming product technical requirements (PTR) process and local type testing
  • Green pathways: higher premiums enjoy reimbursement and are exempt from China Volume-based Purchasing (VBP)
  • Great Bay Area & Hainan Special Policy for NMPA un-approved devices use in China
  • Mastering “Made in China” requirements and MAH
  • New Perspective on Clinical Evaluation Pathways: clinical evaluation decision tree, overseas clinical data acceptance, clinical trial or not, piloted real-world data
  • PMS/QMS (NHSA code, AE, Recall & Overseas Inspection)

Audience Learning Level:

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

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.


Cancellations

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.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

 

Questions

For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshophttps://www.raps.org/website/virtual-event-help

For 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.

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