- Download 3
- File Size 0.00 KB
- File Count 1
- Create Date January 27, 2020
- Last Updated January 6, 2022
2019 NMPA (CFDA) Key Updates & Trends: Look Ahead to 2020
Hundreds of new NMPA regulatory policies, guidelines, standards and announcements were released in 2019. These updates have a significant impact on new submissions, as well as approved and renewal products. This free webinar will provide an overview of the key NMPA changes and their implications on manufacturers.
Also for the first time in China, the piloted MAH system allows for the separation of the manufacturing entity from the product design entity for domestically manufactured devices. Likewise, more aggressive clinical regulations and the use of real world data will reduce the number of clinical trials. Attendees will learn how manufacturers or inventors can shorten their time to market for new submissions, allow enough lead time for renewal and when to file for modifications to avoid penalties.
• Standards & Guidelines
• Clinical Pathways: Overseas Clinical Data Acceptance & Piloted Real World Data
• MAH, UDI & eRPS
• SaMD & AI
• QMS (AE, Recall & Overseas Inspection)