Research on the Standardization System of Diagnosis Products at Home and Abroad / 中国医疗器械杂志

ABSTRACT

<p><b>OBJECTIVE</b>The quality of diagnostic products is closely related to people's health. The standards and standardization system are essential to IVD industry and supervision.</p><p><b>METHODS</b>Through a study of the standards of ISO, EU, the USA and China, a comparative analysis was carried out.</p><p><b>RESULTS</b>China's IVD standardization system is different from other organization in terms of standard quantity, type and content. The standardization system has its own characteristics, and conforms to the current industrial characteristics and regulatory needs.</p><p><b>CONCLUSIONS</b>Some suggestions are put forward to provide references for strengthening supervision of IVD products.</p>