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Latest Regulations

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Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20240828 Usage,Supervision & Inspection,Distribution,Registration & Filing,Pre-Market,Manufacturing,Clinical Evaluation,Product Type Testing 2024-08-28 2024-08-26
Status Issued By Level of Legal Effect Product Category Draft UNKNOWN UNKNOWN UNKNOWN
Guidelines for quality control technology evaluation of chromosomal aneuploidy detection reagents before embryo implantation (high-throughput sequencing method)
Regulation No. Product LifeCycle Issued Date Implemented Date NIFDC-20170315-2 Pre-Market 2017-03-15 2017-03-15
Status Issued By Level of Legal Effect Product Category Valid National Health … Work Documents IVD
Guidelines for quality control technology evaluation of fetal chromosomal aneuploidy detection reagents based on free DNA from pregnant women (high-throughput sequencing method)
Regulation No. Product LifeCycle Issued Date Implemented Date NIFDC-20170315-1 Pre-Market 2017-03-15 2017-03-15
Status Issued By Level of Legal Effect Product Category Valid National Health … Work Documents IVD
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