Class I IVD Product Filing
- Time of issue:2021-03-19 18:49:37
According to Administrative Measures for the Registration of IVDs, the classification of IVDs based on the detection principle or detection method mainly includes biochemical diagnostic reagents, immunological diagnostic reagents, molecular diagnostic reagents, microbial diagnostic reagents, urine diagnostic reagents, coagulation diagnostic reagents, etc. Among them, biochemical, immunological, and molecular diagnostic reagents are the three main categories of diagnostic reagents in China.
In accordance with drug management, IVDs used for blood source screening and IVDs labeled with radionuclides do not fall within the management scope of the Administrative Measures for the Registration of IVDs.
➣ Required Documents：
1.Product risk analysis
2.Product technical requirements
3.Product testing report
4.Clinical evaluation data
5.Product manual and label samples
6.Quality management system documents related to product development and production
7.Other information required to prove the product is safe and effective
➣ NMPA administrative fee: none
➣ Estimated timeline: acceptance on spot
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