On February 9, 2022, the NMPA (National Medical Products Administration) announced (No.8-2022) the new guideline for writing the PTR (product technical requirements) for medical devices.
As manufacturers will be aware, the PTR is equally important as the final NMPA certificate because the PTR is an annexure to the certificate. The PTR also forms the basis for local testing in China.
Highlights on New Product Technical Requirements
In general, the PTR covers basic information such as product name, model, product specification, performance indicators, testing methods, terminologies, etc.
- According to the new guideline, performance indicators should be measurable or explanable in terms of safety and functionality.
- For instance, if the intended use of a hemodialysis product is to remove target substances, the PTR should measure the remained amount of substance to demonstrate the basic functionality of the product.
By Julie Zhang and Jacky Li. Contact Cisema if you would like to learn more.