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2021 China NMPA (CFDA) Key Updates and 2022 Forecast (On-Demand)

1.0 RAC Credits Members: $0 | Nonmembers: $25
2021 China NMPA (CFDA) Key Updates and 2022 Forecast (On-Demand)

This is an On-demand recording from February 2022.

The China National Medical Products Association (NMPA) introduced a series of significant changes to medical device, IVD, companion diagnostic, and combination products regulations in 2011. Dozens of new regulations and major updates in the forms of policies, guidelines, standards, and announcements were released in 2021 with the implementation of decree Order 739, “Regulation on the Supervision and Administration of Medical Devices”.

In a significant progression, Chinese medical device regulators have begun to recognize the self-test report [JM1] from manufacturers and developed guidelines on the requirements and qualifications for self-test reports.

China has also published adjustments to the Good Clinical Practice (GCP) framework, including guidelines for Clinical Evaluation Reports (CER), establishing equivalence, and determining when to do clinical trials. The e-filing catalog has also added a section requirement on Good Manufacturing Practice (GMP). These updates and changes have impacted the complete product life cycle including new submissions, renewals and postmarket surveillance.

Sign up for this live webcast and learn how these updates and changes affect your work and what to expect from the China NMPA in the year ahead.

Learning Objectives

Upon completion of this program, you will:

  • Understand the key regulatory and clinical requirement changes that took place in 2021 and implications.
  • Know the top five strategic factors to consider in submission that will impact approval time, downstream sales and postmarket compliance.
  • Be able to discuss the latest fast-track policy for China market entry in the Greater Bay Area and Hainan province.

Pricing/Deadlines

17 January 2022 – 28 February 2022: $0 Members | $0 Nonmembers


Who Should Attend

  • Clinical affairs professionals
  • Managers in the life sciences industry
  • Regulatory affairs professionals
  • Quality affairs professionals
  • Medical affairs professionals
  • R&D managers
  • Compliance managers
  • Operations managers
  • Marketing and business executives
  • Chief financial and commercial managers

Agenda

TBD

Speaker(s):

 
Grace Fu Palma

Grace Fu Palma brings 20+ years of MedTech and diagnostic industry experience. She is the CEO of China Med Device with offices in Beijing, Hainan and Boston, providing turnkey solutions for western medical device/IVD/CDx products companies to enter China with NMPA (CFDA) regulatory and clinical affairs (RA, QA, CER, RWD, CRO etc.) services. The company has processed 1,000+ NMPA certificates and accelerated 250+ Chinese and western companies’ success. A seasoned bilingual and bicultural MedTech executive, she has held a variety of marketing, operational and strategic development management positions at both large multinationals and startup companies. 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 and a frequent contributing writer to multiple regulatory journals. 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.


 

Cancellation Policy

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

RAPS will send an electronic letter or a certificate of attendance following the workshop.

Questions

Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org  
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