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- Create Date March 9, 2023
- Last Updated July 22, 2023
Key Regulatory Changes from 2022 and Look Ahead to 2023
Join our webinar to stay up-to-date on the changing regulatory landscape for medical devices in China. With ongoing implementation of Order 739 and the country's re-opening to the world, it's more important than ever to stay informed.
Our expert speaker will review key policies, guidelines and standards from the past several months, as well as provide insights on what to expect for the remainder of 2023. They will also share strategies for manufacturers and innovators to shorten time-to-market, mitigate impacts of PTR tests and standards changes, and avoid penalties from post-market compliance inspections.
• 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.