Eurasian Medical Device Quality Management System Requirements

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.

One thought on “Eurasian Medical Device Quality Management System Requirements

  1. Pingback: Three Things You Should Know about Medical Device Regulatory Changes in Russia in 2017 | Medical Device Regulations in Russia and Eurasian Union

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