NMPA CMDE Releases Two IVD Registration Review Guiding Principles (Announcement No. 22, 2026)

On July 2, 2026, the Center for Medical Device Evaluation (CMDE) of the National Medical Products Administration (NMPA) officially released two in vitro diagnostic (IVD) reagent registration review guiding principles: the Guiding Principles for Registration Review of Fetal Chromosomal Aneuploidy (T21, T18, T13) Detection Reagent Kits Based on High-Throughput Sequencing (2026 Revision) and the Guiding Principles for Registration Review of Glucose-6-Phosphate Dehydrogenase Detection Reagents.

About These Two Guiding Principles:

1. Guiding Principles for Fetal Chromosomal Aneuploidy Detection Kits (2026 Revision)

This guiding principle applies to reagent kits that employ low-depth whole-genome high-throughput sequencing to analyze cell-free fetal DNA in maternal peripheral blood plasma for prenatal screening of fetal trisomy 21, trisomy 18, and trisomy 13. It provides comprehensive registration review requirements covering regulatory information, summary materials, non-clinical data (including product technical specifications, analytical performance evaluation, stability studies, cutoff value determination, etc.), clinical evaluation materials, product instructions, and quality management system documentation.

2. Guiding Principles for Glucose-6-Phosphate Dehydrogenase Detection Reagents

This guiding principle applies to reagents that employ the glucose-6-phosphate substrate/rate method for the in vitro quantitative detection of glucose-6-phosphate dehydrogenase (G6PD) activity in human venous whole blood samples, for the auxiliary diagnosis of hereditary erythrocyte G6PD deficiency. It covers key registration application elements including product naming, classification code, summary materials, non-clinical data (analytical performance evaluation, stability studies, reference interval determination, etc.), clinical evaluation materials, and product instructions.

These two guiding principles aim to strengthen guidance for IVD product registration applications and technical review, serving as references for both applicants and reviewers.