The National Medical Products Administration (NMPA) has announced the priority review approval for Roche Diagnostics GmbH under its Priority Approval Procedure for Medical Devices (2016 No. 168).
The approved products include:
- β-Amyloid (1-42) CSF Test Kit (Electrochemiluminescence Method)
- Total-Tau Protein CSF Test Kit (Electrochemiluminescence Method)
- Phospho-Tau (181P) CSF Test Kit (Electrochemiluminescence Method)
These Alzheimer’s disease biomarkers have been granted priority review as clinically urgent innovations with no equivalent products currently registered in China.
This milestone highlights China’s commitment to accelerating access to advanced diagnostics for neurodegenerative diseases.
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