Type testing
Testing in a China medical device testing centre
Registration testing for medical devices is performed against the applicable China standards, and the test file has to identify every standard that applies to the device and explain any that do not.
We prepare the standards list and the product technical requirements, book the testing centre and manage the samples.
What this covers
- Applicable standards list and justification of exclusions
- Product technical requirements document
- Electrical safety and EMC for active devices
- Testing centre selection, booking and sample management
- Review of existing reports from other markets for reusability
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