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Learn the Ins & Outs of China NMPA E-Filing

6.0
RAC Credits
Virtual Programs Virtual Programs
Wednesday, 27 April 2022 (10:00 AM) - Thursday, 28 April 2022 (1:00 PM) Eastern Time (US & Canada)

Implementation of China Order 739 in June 2021 introduced a series of changes in China NMPA registration requirements. This 2022 intensive, two-day workshop will reflect the updates and provide the overview of the updated 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.

Learning Objectives

Upon completion of this program, you 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.

Pricing/Deadlines

17 January 2022 – 11 April 2022: $495 Members | $580 Nonmembers

12 April 2022 – 27 April 2022: $580 Members | $680Nonmembers


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

Day 1 Wednesday, 27 April 2022 10am – 1pm EST

10:00 – 10:10 am

Opening Session and Introduction

10:10 – 11:00 am

China NMPA Market Approval Process Overview for Device and IVD (new registration, renewal, modification and administrative types)

 

Grace Fu Palma, CEO, China Med Device LLC

11:00 – 11:45 am

Overview of China Electronically Regulated Product Submission (eRPS) - CA certificate process and key structure

 

Sara Li, RAC, Senior Regulatory Specialist, China Med Device LLC

11:45 – 12:00 pm

Break

12:00 –12:40 pm

New step for China submission: Filing Review Requirements and Standards for medical device and IVD.

 

Viki Chen, Project Manager, China Med Device LLC

12:40 am-1:00 pm

Q&A session for day 1

 

Day 2 Thursday, 28 April 2022 10am – 1pm EST

10:00 – 10:55 am

eRPS System Catalog for Medical Device Products

 

Sara Li, RAC, Senior Regulatory Specialist, China Med Device LLC

Maple Chen, QA Project Manager, China Med Device, LLC

10:55 – 11:45 am

eRPS System Catalog for IVD Products

 

Qianqian ZHU, MBA, LLM, RAC, Director, International Regulatory Affairs, Immucor, Inc.

11:45 – 12:00 pm

Break

12:00 – 12:40 pm

Best practice, Tips and Case studies for E-filing

 

Crystal Nie, Director of Regulatory Affair, Johnson & Johnson Medical ASPAC

12:40 pm - 1:00 pm

Q&A session for day 2

NOTE: Program content may vary.


Instructors:

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..

Sara Li

Sara Li has more than 7 years of direct regulatory experience with Class 2 and Class 3 medical devices at multinational companies in both the US and China. She has been involved in new product development, modifications, testing, submission, and clinical strategy. She has solid technical knowledge of active devices, digital products, and software as a medical device. She has worked extensively with NMPA testing and technical evaluation centers to support NMPA submissions. Her education includes BS and MS in Electrical Engineering and bioengineering in both US and China

Qianqian Zhu

Qianqian Zhu, MBA, LLM, RAC is director of international regulatory affairs with Immucor Inc. She has more than nine years of experience working on China NMPA registration, covering type test and clinical trials. Zhu has obtained more than 30 initial approvals of Class III medical devices, IVDs and drugs in China. She is an expert on China CER and PRER technical writing and has worked with CMDE on the drafting and releasing of five IVD technical review guidances. She also worked with BIMT and NIFDC on IVD national standard development. Zhu practiced law and international trade in China and the UAE prior to coming to the US. She earned the RAC Global in 2016.

Crystal Nie

Crystal Nie is director of regulatory affairs at Johnson & Johnson Medical ASPAC. She has more than 16 years of regulatory affairs experience at J&J medical, with five years focused on the ASPAC region as regulatory portfolio lead for countries including Japan, China and Australia. She has diverse experience in medical devices and IVDs with regulatory expertise on wide range of products in areas including cardiovascular, neurovascular, orthopedics, robotics, software as a medical device, infection prevention, electrophysiology, surgical and non-surgical aesthetics, diabetes care devices and CDx IVD reagents. Nie served as co-chair of China APECMED COE, was a member of China’s Ministry of Industry and Information Technology and a member of SAC/TC 136 National Technical Committee of Standardization on Medical Clinical Laboratory and In Vitro Diagnostic System. She is the acquisition and divestiture regulatory lead for ASPAC.

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. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone. 

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. 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