The Eurasian Economic Commission published the Order # 134 (link in Russian) and approved the draft resolution on requirements on quality management system (QMS) for medical device manufacturers in Eurasian Union. This news was published on 2nd October 2017 on the website of the Eurasian commission and the Russian medical device regulator Roszdravnadzor.
The requirement on QMS is the thirteenth and the last adopted ‘‘second level’’ document of Eurasian medical device regulation model.
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