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.
- Base para la producción y la vigilancia posterior a la comercialización: Los resultados de las pruebas de tipo se suelen tener en cuenta durante las inspecciones de fabricación y el control de calidad posterior a la comercialización.
Learning Content
Al finalizar este taller, los participantes podrán:
- Understand the role of type testing in Chinese regulatory processes.
- Learn how to prepare technical documents and samples for submission to Chinese laboratories.
- Gain insights into the testing requirements under GB and YY standards.
- Develop strategies to handle deficiencies and non-conformities in type testing.
- Learn how to integrate type testing results into product development, quality control, and post-market compliance.
- Compare el resultado de la prueba con los requisitos técnicos del producto y sea coherente con otros documentos técnicos.
Estructura del taller
Fundamentos de la prueba de tipos china
- ¿Qué son las pruebas de tipos?
- Overview of GB/T and YY standards for medical devices.
- El papel de las pruebas de tipo en el proceso regulatorio chino.
Preparing for Type Testing
- Documentos clave necesarios para la presentación de la prueba de tipo.
- Preparación de especificaciones técnicas y requisitos técnicos del producto (PTR) para pruebas.
- Buenas prácticas para la preparación y envío de muestras.
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.
Actividades interactivas
- Caso práctico: Traer el orden correcto de las tareas típicas de las pruebas de tipo con la persona asignada.
- 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:
- Gerentes de asuntos regulatorios.
- Desarrolladores de productos, responsables de calidad y gestores de proyectos involucrados en el registro de dispositivos médicos en China.
- Manufacturers new to Chinese registration processes or seeking to improve their type testing efficiency.
Cost and Duration
Cost and duration are customized based on:
- El nivel de comprensión y experiencia previa con las pruebas de tipografía chinas.
- El número de participantes.
Formato estándar:
- 2 sessions, including a case study in the first session.
- Delivered remotely or in person (available in Europe, primarily around Germany).
