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NMPA Announcement on Issuing 5 Technical Review Guidances for Registration

CCFDIE|Updated: 2021-04-15

To strengthen the supervision and guidance of medical device registration and further improve the quality of registration review, NMPA has organized to formulate the Guidance for Package Insert Update and Technical Review of Oncology Companion Diagnostic Reagents Based on Similar Therapeutic Products, the Technical Review Guidance for the Registration of Real-time Fluorescence PCR Analyzer, the Technical Review Guidance for the Registration of Rotavirus Antigen Test Reagents, the Technical Review Guidance for the Registration of Group B Streptococcus Nucleic Acid Test Reagents, and the Technical Review Guidance for the Registration of Human Parvovirus B19 IgM/IgG Antibody Test Reagents, which were issued on April 7.