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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
This intensive, two-day workshop will provide an overview of electronic submissions to the China NMPA for devices and IVDs called electronic Regulated Product Submissions (eRPS), which are similar to eCTD submissions to the U.S. FDA. eRPS went into effect on June 24, 2019 in China and affects domestic class III, imported class III and imported class II medical devices and IVDs. The workshop will review the eRPS structure as well as the key elements and necessary processes for building complete and successful electronic submissions. By attending this program, regulatory professionals and overseas manufacturers will gain a thorough understanding of eRPS and better position themselves to meet the new requirements in China.
Pricing Amounts & Deadlines
16 November 2020 - 21 December 2020: Member $480 | Nonmember $540
22 December 2020 - 19 January 2021: Member $540 | Nonmember $600
After this program, participants will…
Understand the key regulations and process of
China NMPA registration.
Know the key components of the eRPS structure
and be familiar with the online eRPS portal.
Know best practices regarding eRPS dossier
Have a thorough understanding of how to apply
for and obtain a China Certificate Authority (CA) certificate.
Who Should Attend?
This workshop will be beneficial for regulatory
professionals, clinical affairs professionals, quality professionals, and engineers
working in the medical device, IVD, CDx and combination products fields who are
involved in China NMPA regulatory work. Attendees will learn the ins and outs
of Chinese eRPS submissions and how to comply with the new requirements from the
Introduction to and overview of the China NMPA
An interactive exercise to aid in understanding
the key steps for registration in China
General introduction to China electrical
Regulated Product Submission (eRPS)
What is a CA certificate? How does one apply for
a CA certificate?
The new step for Chinese submissions: filing
review requirements and standards for medical devices and IVDs
Comprehensive review of eRPS submissions,
The RPS-ToC catalog and requirements
An introduction to the RPS catalog structure
A review the entire lifecycle of an electrical
submission, from first steps to eRPS
Best practices, tips and case studies
Grace Fu Palma, CEO, China Med Device LLC
Grace brings 20+ years of MedTech and diagnostic industry
experience. She is the CEO of China Med Device (www.ChinaMedDevice.com) 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 meeting and a frequent contributing
writer to multiple regulatory journals. Grace grew up in Beijing, China and has
a bachelor’s degree from Peking University, China, and an MBA from Yale
University in New Haven, CT.
Wei (Elva) Shang, RAC, CQA , Senior RA Manager, GE Healthcare
Elva has over 15 years of experience in the medical device
industry and has held several regulatory affairs and quality management roles
with Medtronic, Hillrom, Siemens and GE Healthcare. In her current role, Elva
leads a team of regulatory professionals who provide regulatory strategy,
submission authoring and product life cycle management to enable business
development initiatives in the global markets in US, EU, China, APAC, Latin
America and worldwide. Elva is RAPS RAC (US, EU, CAN, GS) and ASQ CQA certified
and specializes in the medical device products industry for global market
Jason Zhang, MD, CRO Director, China Med Device LLC
Jason Zhang, MD, has over 10 years of 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
first domestic Linear Accelerator in China with 75 patients in less than a year,
approved by CFDA through the Innovation Device pathway. He is also a patent
owner at Philips and has several publications on MRI guided HIFU.
Yan Sheng, PhD, Project Manager, China Med Device
Yan Sheng grew up in China and has many years of working
experience in the life science industry in both the U.S. and China. She
received her bachelor’s degree in pharmaceutical science in China and holds a
PhD from Oregon State University, where her doctoral studies focused on natural
products discovery within the microbial world. With more than 6 years of
experience in academia, she is familiar with cutting edge technologies in
chemistry and microbiology.
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 via our online cancellation form. RAPS is unable to accept
cancellations by phone. Please specify the name of the person registered and
Substitutions may be accepted
with written approval from RAPS and must be submitted to firstname.lastname@example.org.
If you have questions or concerns, please contact RAPS
customer service at +1 301 770 2920, ext. 200, or via email at email@example.com.