Research on the Standardization System of Diagnosis Products at Home and Abroad / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation
;
(6): 361-364, 2018.
Article
in Chinese
| WPRIM
| ID: wpr-689787
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>
Full text:
Available
Index:
WPRIM (Western Pacific)
Type of study:
Diagnostic study
/
Practice guideline
Language:
Chinese
Journal:
Chinese Journal of Medical Instrumentation
Year:
2018
Type:
Article
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