NMPA CMDE releases the Guidance on Registration Review of blaKPC Carbapenemase Resistance Gene Detection Reagents (Announcement No. 30 of 2026)

On 22 October 2026, the Center for Medical Device Evaluation of the National Medical Products Administration officially issued the above guidance. The document is intended to guide applicants in preparing and drafting registration submissions for blaKPC detection reagents and to provide reference for technical review; it applies to product registration and change registration.

The guidance applies to reagents based on real-time PCR and other molecular biology technologies for qualitative in vitro detection of the carbapenem resistance gene blaKPC in human sputum, rectal swabs and isolated colony samples. Such products are managed as Class III in vitro diagnostic reagents, with classification code 6840.

The review points cover regulatory information, summary materials, non-clinical data, clinical trials, and product instructions/labels. Applicants should focus on intended use and rationale for gene subtype coverage; analytical performance studies (sample stability, accuracy, precision, limit of detection, inclusivity, analytical specificity, nucleic acid extraction performance and reaction system); cut-off values; stability studies; and clinical trial site selection, comparator or Sanger sequencing/drug susceptibility test design, case selection and statistical analysis. The instructions should clearly state the clinical significance of different sample types, test methods, interpretation of results, limitations and precautions.

For companies developing blaKPC detection reagents, the message is clear: registration submissions need to address gene subtype coverage, analytical performance confirmation, clinical intended use and sample types through separate studies, and support safety and effectiveness evaluation with complete and traceable data.