China: Key Regulatory Changes from 2022 and Look Ahead to 2023

2022 was a year of continuous change in China’s regulations for medical devices with the ongoing implementation of Order 739. Now, China is re-opening to the world after COVID isolation and is strongly welcoming foreign investment. This webinar will review key regulatory policies, guidelines, standards, and announcements over the past several months and look ahead to the remainder of 2023. The session will also discuss the ways manufacturers and innovators can shorten time-to-market for new submissions, mitigate impacts of PTR tests and standards changes, and navigate increased post-market compliance inspections and avoid penalties. Overseas manufacturers can create a strategy and implementation plan to take advantage of the “made-in-China” policy for quicker approval, even before receiving FDA/CE approval.

Key Topics

• How to leverage Order 739 to shorten the time-consuming product technical requirements (PTR) writing process and local type testing.
• Greater Bay Area and Hainan special policies for use of non-approved devices within China.
• “Made in China” requirements and policies around market authorization holders (MAH).
• New perspectives on clinical evaluation pathways, including clinical evaluation decision tree, overseas clinical data acceptance, clinical trials, and piloted real-world data.

Presented by

Featured Speaker

Grace Fu Palma, MBA
Founder and Principal, China Med Device, LLC

• 20+ years of experience driving global strategy, commercialization, partnerships, and cross border operations for both large multinationals and startup companies.
• Led and managed cross-border teams developed regulatory and clinical strategies and execution of the associated submission and clinical evidence a couple of hundred companies.
• Established and led team to provide practical guidance and execution in China MAH, GMP, overseas inspections, and post market compliance,
• Regulator speaker at key national and local Medtech meetings (RAPS, AdvaMed, FDAnews etc) and writer for multiple journals on NMPA (CFDA) regulatory and clinical affairs.
• Grew up in Beijing, China, received Joint BA/BS-Peking University, China, and an MBA-Yale University, USA.
• Founder of Chinese American Heart Association in 2005 (www.CnAHA.org) with 500+ cardiovascular clinicians and researchers with Chinese origin.

Registration

This webinar is free for AdvaMed members and government employees. Click here to check if your company is an AdvaMed member.

• AdvaMed Members: $0.00
• AdvaMed Accel Members: $0.00
• Government /Nonprofit: $0.00
• Non-Members: $100.00