China NMPA Medical Device Regulations & NEW Revisions and Guidance

China is known to have one of the most comprehensive and challenging regulatory systems in the world. Its regulatory authority, National Medical Products Administration (NMPA), continues to update its regulations, requirements, and processes. Following the significant regulation updates in 2014, NMPA has released further revisions in the last two years.

This interactive program will explore the fundamentals of Chinese NMPA regulations for medical devices, emphasizing updated revisions and guidance released since 2020.

Experts in Chinese regulations will present a systematic review of all elements in the NMPA regulations including clinical trial to quality management, product registration and post market surveillance. Attendees will gain exclusive insight into the presenters’ personal experiences and are encouraged to submit questions in advance and ask questions during the event to foster discussions.

Registration Fees & Deadlines

1 April – 11 September 2022: Member $825 | Nonmember $970
12 September – 7 November 2022: Member $970 | Nonmember $1,150

Learning Objectives

• Understand the fundamental framework of Chinese NMPA regulations for medical devices
• Have a thorough knowledge of all elements in the Chinese regulations including clinical trial to quality management, product registration, and postmarket surveillance.
• Understand the implications of the latest developments in NMPA policies and guidance in the last two years.
• Be able to apply other people’s insights and experiences to their own submissions.

Who Should Attend?

This workshop is best suited for regulatory affairs professionals with more than three years of experience looking to broaden their knowledge of China NMPA regulations.

Agenda

Day 1 - Monday, 7 November 2022, 8 a.m. – 12:00 p.m. Eastern Time

Topics: Premarket

• NMPA: the agency and its responsibilities, regulations, structure and scope
• Pre-Market: QMS, R&D, V&V, classification, testing, documents, review process
• Expedited programs and regional programs

Day 2 - Tuesday, 8 November 2022, 8 a.m. – 12:00 p.m. Eastern Time

Topics: Clinical

• Clinical Evaluation: Same-type device, similar-device, guidance, and templates
• Clinical Trial in China: Chinese GCP, process, management, documents
• Strategy and Management: overseas trials vs. Chinese trials and do’s and don’ts

Day 3 - Wednesday, 9 November 2022, 8 a.m. – 12:00 p.m. Eastern Time

Topics: Postmarket

• Postmarket: amendment, extension, annual risk analysis reports, local healthcare registration and maintenance
• Quality management audits
• Strategy discussions

Instructors:

Chang-Hong Whitney, MBA, RAC

Chang-Hong Whitney has spent more than 30 years in the medical device industry in both China and the US. She founded Whitney Consulting Ltd., focusing on Chinese regulations for medical devices and IVDs, servicing exclusively international clients around the world, including Fortune 500 companies. Whitney is an active member of the RAPS community, presenting China regulatory updates at RAPS conferences, organizing workshops and seminars, editing educational material, and serving on volunteer committees. She holds an MBA from Babson College and undergraduate degrees in electrical engineering and international business in China.

Vic Zhang, PhD, RAC

Vic Zhang is currently the vice president of regulatory affairs at LeMaitre Vascular, a medical device company focused on cardiovascular diseases, where he has held multiple management positions for the past 10 years. He is responsible for the company’s global regulatory affairs activities, including China registrations and clinical trials. He has previously worked in regulatory roles at Medtronic, and Smith & Nephew. He earned the RAC credential for the US, Canada, and the EU. Zhang holds a PhD in chemistry from Rutgers University and bachelor’s from Tsinghua University in China.

Weiping Zhong, PhD

Weiping Zhong is the global director of risk management for GE Healthcare (GEHC), leading risk management, cybersecurity-safety risk management, and clinical evaluation for all GEHC device products covering imaging, patient care, and digital healthcare. Prior to joining GEHC, Weiping held multiple positions in Bayer Healthcare – Diabetes Care, including QA/RA head for APAC, statistician, and reliability and quality engineer. He holds a PhD in mechanical engineering and a master’s in industrial and operations from the University of Michigan, as well as a master’s in mechanical engineering from Dalian University of Technology in China.

Lina Zhu, MS

Lina Zhu is currently the head of regulatory affairs operations at Whitney Consulting Ltd, where she has been engaged in the work of medical device regulatory affairs for nearly nine years. Zhu holds a master's degree in chemistry from Southwest University of Chongqing, and worked as a teacher for two years following graduation. She is familiar with NMPA registration regulations and completed many challenging projects.

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 at the following the webcast.

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