• Version
• Download 436
• File Size 143.92 KB
• File Count 1
• Create Date October 21, 2019
• Last Updated February 7, 2023

2019 China NMPA Blue Book

Medical devices and IVD manufacturers are facing a vastly different regulatory landscape in China. This all-in-one resource provides an overview on dozens of new regulations, along with clear explanation of how these could affect your registrations, renewals and post-market compliance.

This 50+ page guide outlines regulatory changes to Product Registration, Clinical Evaluation, Manufacturing, Labeling and Post-Market Surveillance, including:

• 3 new fast-track approval paths for innovative-devices
• Rules on acceptance of overseas clinical data
• 11 proposed changes to lVD clinical trials
• New technical standards for devices and quality systems
• Details on strict enforcement of adverse event reporting
• What to expect from onsite inspections of overseas manufacturers?
• Guidance on NMPA’s registration fees and clinical process
• Summary of manufacturer audit results
• Recalls and innovative approvals issued last year
• Plus, an extensive index of regulatory documents issued in 2018 covering Policy, Technical Guidance and Industry Standards

“The 2019 China NMPA Blue Book will help foreign medical device and diagnostic companies to overcome the barriers and to be kept informed of the Chinese regulatory system due to language and culture differences. It will be a valuable tool for overseas companies to enter China.” — Mr Gong Zhi Jun, Director at NMPA’s Administration Institute of Executive Development

Attached Files