Workshop of Chinese type testing of medical device (IVD)

What is Chinese Type Testing of Medical Devices?

Chinese type testing of medical devices refers to the mandatory type testing conducted by certified Chinese laboratories as part of the regulatory approval process in China. These tests evaluate whether a medical device meets the required technical specifications and standards based on Chinese regulations and applicable GB or YY standards.
Type testing is a crucial step in the approval process, ensuring compliance and laying the foundation for market entry in China.

Why is Chinese Testing Important?

• Regulatory Compliance: Type testing is a prerequisite for medical device registration in China. Without successful type testing, no approval is granted.
• Quality and Safety Assurance: It ensures the medical device adheres to specific technical and safety standards, reducing risks in the market.
• Foundation for Production and Post-Market Surveillance: Results of type testing are often referenced during manufacturing inspections and post-market quality control.

Learning Content

By the end of this workshop, participants will:

1. Understand the role of type testing in Chinese regulatory processes.
2. Learn how to prepare technical documents and samples for submission to Chinese laboratories.
3. Gain insights into the testing requirements under GB and YY standards.
4. Develop strategies to handle deficiencies and non-conformities in type testing.
5. Learn how to integrate type testing results into product development, quality control, and post-market compliance.
6. Match testing result with product technical requirement and consistent with other technical document

Workshop Structure

Foundations of Chinese Type Testing

• What is type testing?
• Overview of GB/T and YY standards for medical devices.
• The role of type testing in the Chinese regulatory process.

Preparing for Type Testing

• Key documents required for type testing submission.
• Preparing technical specifications and Product Technical Requirement (PTR) for testing.
• Best practices for sample preparation and submission.

Managing Type Testing Challenges

• Understanding common deficiencies and non-conformities in type testing.
• Case studies on overcoming typical challenges.
• Developing an efficient communication strategy with Chinese testing laboratories.

Interactive Activities

• Case Study: Bring correct order of typical tasks of type testing with assigned party
• Exercise: Prepare a checklist for submitting samples and design review documents for testing

Free Kit

Participants will receive a comprehensive Type Testing Kit that includes:

• Templates for technical documents and PTRs.
• A checklist for preparing for type testing and for testing report.

Target Audience

This workshop is aimed at:

• Regulatory affairs managers.
• Product developers, quality managers, and project managers involved in Chinese medical device registration.
• Manufacturers new to Chinese registration processes or seeking to improve their type testing efficiency.

Cost and Duration

Cost and duration are customized based on:

• The level of understanding and prior experience with Chinese type testing.
• The number of participants.

Standard Format:

• 2 sessions, including a case study in the first session.
• Delivered remotely or in person (available in Europe, primarily around Germany).