Discussion on the Revision of National Administrative Provisions for the Sampling and Testing of Quality Supervision on Medical Devices

VernacularTitle:《国家医疗器械质量监督抽验管理规定》修订探讨
Author: Qing HAO ¹ ; Xian SHI ; Xintao ZHANG ; Jiong ZHU
Author Information

1. 中国食品药品检定研究院
Keywords: medical devices; sampling and testing; administrative provisions; revision
From: Chinese Journal of Medical Instrumentation 2013;(5):373-375,378
CountryChina
Language:Chinese
Abstract: This paper focused on the revision of national administrative provisions for the sampling and testing of quality supervision on medical devices, according to the practice, it introduced the scope of application, Chinese system of sampling and testing on medical devices, the methods of sampling, inspection standards, re-inspection institutes and the other issues should be taken into consided and discussed. The current situation of these issues, main idea of the revision and influences of the provisions were also analyzed to provide theoretical exploration for the revision.