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Category: IVD & CDx

NMPA: Four IVD Guidelines Issued

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

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Seven IVD Guidelines Ask for Feedback

The NMPA issued seven IVDs draft guidelines on December 2, 2022, soliciting public opinions. Feedbacks need to be submitted by December 16, 2022. Draft Guideline on Submission Materials of Blood

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