[Assessing the conformity of medical devices for in vitro diagnosis: international and domestic experience].
The conformity of medical articles was assessed for in vitro diagnosis is the most importance procedure for their entering the market. This paper describes the basic elements of assessment of the conformity of these articles, analyzes worldwide experience, shows differences in the Russian regulatory system in the circulation of medical articles for in vitro diagnosis, and gives recommendations for its improvement.
Manzeniuk
I N
IN
Shipulin
G A
GA
Men'shikov
V V
VV
D019411:Clinical Laboratory Techniques / Q000295:instrumentation* / Q000592:standards; D004864:Equipment and Supplies / Q000592:standards*; D007883:Legislation, Medical; D011786:Quality Control