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• Create Date January 31, 2017
• Last Updated February 7, 2023

NMPA (CFDA) Key Updates GMP/QMS Overview

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.

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