Event Details

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

Objectives

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 content.

·        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 China NMPA.

Agenda

·        Introduction to and overview of the China NMPA registration process

·        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, including:

o   The RPS-ToC catalog and requirements

o   An introduction to the RPS catalog structure

o   A review the entire lifecycle of an electrical submission, from first steps to eRPS

o   Best practices, tips and case studies

Speakers

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 regulatory compliance.

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 LLC

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.

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 via our online cancellation form. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title.

Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org. 

If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at raps@raps.org.