Measures for the Administration of ADR Monitoring and Re-evaluation of Medical Devices (hereinafter referred to as “the Measures”) are issued by State Administration for Market Regulation (SAMR) and National Health Commission (NHC) on August 13. 2018, and it has come into force on January 1, 2019.
The Measures contain 9 chapters and 80 articles. The objectives of developing the Measures are:
1. Clarify the responsibilities for enterprises and administrative authorities that are participating in ADR monitor and re-evaluation. Specify working details for all parties.
2. Strengthen current supervising measures, and improve the binding force for existing administration system.
3. Improve the working level for ADR monitor and re-evaluation. Make sure product risks can be discovered at an early stage to protect public health.
The main content of the Measures covers responsibilities, legal liabilities and working scope of involving parties; reporting and evaluation methods and requirements; monitoring and management system for ADR monitor and re-evaluation.
BESTAO have translated the full text of the Measures. For the complete file of the English version, please visit:
http://www.bestao-consulting.com/translated/detail/292
Any question you may have or help you may need on the topic, please contact: