Workshop of design change of approved medical device in China

Why This Workshop?

Navigating design changes for medical devices in China is a critical yet complex process. The National Medical Products Administration (NMPA) requires strict assessments and documentation to determine whether a design change is "significant" and whether re-registration or supplementary filings are necessary. Understanding this process is vital to maintaining compliance and avoiding market disruptions.

Workshop Objectives

By attending this workshop, participants will:

1. Learn how to assess design changes using best practise.
2. Understand the difference between significant and non-significant changes.
3. Develop strategies to streamline documentation and approval processes.
4. Explore how to integrate design change assessments into existing quality systems.
5. Identify best practices to communicate with NMPA during change submissions.

Workshop Content

Overview of Design Changes in China

• Regulatory framework for design changes under NMPA.
• Key differences between Chinese requirements and global standards.

Significant vs. Non-Significant Changes

• Criteria for determining the significance of a change.
• Practical examples and decision-making flowcharts.

Preparing for a Design Change Submission

• Key documents required for significant changes.
• Common pitfalls and how to avoid delays in approval.

Integrating Design Change Assessments into Quality Systems

• Creating transparent and traceable change management processes.

Key Takeaways

• A structured approach to assess design changes for Chinese regulatory compliance.
• Practical tools, templates, and checklists to simplify documentation.
• Insights into maintaining a smooth approval process with the NMPA.

Target Audience

• Regulatory affairs managers handling Chinese market submissions.
• Quality assurance and R&D teams managing product lifecycle changes.

This workshop combines expert guidance, case studies, and actionable tools to ensure your design changes comply with Chinese regulatory requirements efficiently and effectively.