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SFDA sets out the principles and procedures for the coverage of products included in the quality management system of in-vitro diagnostic reagents
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In order to further clarify the scope of products included in the quality management system of in-vitro diagnostic reagents under the Implementation Requirements of Quality Management System Examination for In-Vitro Diagnostic Reagents (Interim), the State Food and Drug Administration (SFDA) formulates the Principles and Procedures for the Coverage of Products Included in the Quality Management System Examination for In-Vitro Diagnostic Reagents, which shall come into force on the day of its publication. | |
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