AI tool to access PTR Change in China
PTR change
The general regualtory affairs for chinese registration (Medical device and IVD) defines all changes as significant change triggering change registration.
DO NOT forget that
- change registration takes years
- testing often needed for change registration
Be an expert to assess PTR change discriminating significant and non-significant change and decide in which registration to intergrate these change in the whole Chinese lifecylce of products.
AI tool
PTR Change Assessment Tool
Professional service
Contact us to have a product tailored change tool. Besides it, you can receive:
- Working instruction of product technical requirement
- Template of PTR traceability
- Working instrucion of change of product technical requirement
- Monitoring sheet of PTR change
