CFDA Key Updates GMP/QMS Overview

CFDA Regulatory Changes 2017

 

China medical device/IVD regulations
are complex.

During this session Grace will discuss recent developments in manufacturing regulations including new GMPs, self-inspections, foreign inspections and trends in enforcement. These developments can affect all medical device companies, whether your manufacturing facilities are in China or abroad.

After this 90-minute session you will have a practical understanding of the following compliance issues:

  • Implementation of the new GMPs, including the procedural rules for inspections, preparation, communicating with investigators, resolving issues, and potential penalties.
  • Transfer of manufacturing sites and amendment of manufacturing and device licenses.
  • Policies and rules on contract manufacturing for medical devices.
  • Handling self-inspections and evaluations of past compliance, including recent examples.