NMPA published the four IVD-related guidelines on January 18, 2024. They are aimed to facilitate manufacturers with more product-specific guidance and clarity in registration process.
Significance of Guidelines
The guidelines are introduced by NMPA Center of Medical Device Evaluation (CMDE). It is not legally binding but highly recommended by regulatory authorities.
NMPA issues new or updated guidelines throughout the year. Given their importance in understanding what the NMPA reviewers are looking for, it is essential that manufacturers keep up to date with the guidelines that are latest to their specific products. One source to get updates on these guidelines is through our complimentary monthly news roundup that you can opt in from our website www.ChinaMedDevice.com
The List
- Registration Guideline on Monkeypox Virus Nucleic Acid Detection Test Kit (Draft)
- Clinical Trial Guideline on Non-Small Cell Lung Cancer-Related Gene Mutation Detection Test Kit based on High-Throughput Sequencing Technology
- Clinical Trial Guideline on Human Immunodeficiency Virus Detection Test Kit
- Registration Guideline on Drug Abuse Detection Test Kit
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- Source: https://chinameddevice.com/nmpa-ivd-guidelines/
