GB/T 29791.1-2013
ActiveIn vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements
体外诊断医疗器械 制造商提供的信息（标示） 第1部分：术语、定义和通用要求
Application Summary AI generated
This standard defines terminology and general requirements for the information that manufacturers must supply with in vitro diagnostic (IVD) medical devices, such as test kits and reagents used in clinical laboratories. It applies to the labeling, instructions for use, and accompanying documentation for IVD products sold in China, ensuring consistent and clear communication of safety, performance, and usage details to healthcare professionals and end-users.
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