China: Guidelines of Products' Technical Requirements Compilation for Medical Devices (No. 8 of 2022) – March 2022
- 2022-03-25 10:32:01
This guideline applies to medical devices including in vitro diagnostic reagents applying for registration or filing with NMPA in China. This guideline only provides general requirements for the format and content of the product technical requirements (PTR) for medical devices and does not specify specific requirements for certain products.
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