Notice of the NMPA on the Release of the Guiding Principles for the Classification and Definition of In Vitro Diagnostic Reagents Related to Second-Generation Gene Sequencing (No. 22, 2025)

Notice of the NMPA on the Release of the Guiding Principles for the Classification and Definition of In Vitro Diagnostic Reagents Related to Second-Generation Gene Sequencing (No. 22, 2025)

Release date: 10th June, 2025

To further strengthen the supervision and management of in vitro diagnostic reagents related to second-generation gene sequencing and promote the high-quality development of the industry, the NMPA has formulated the "Guiding Principles for the Classification and Definition of In Vitro Diagnostic Reagents Related to Second-generation Gene Sequencing" (hereinafter referred to as the "Guiding Principles"), which are hereby released and the relevant matters are announced.

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