QMS And Lab Accreditations Allow Russian Regulator To Green Light Eurasian Device System

29 Nov 2017

Harmonization of medical device regulation in the five member-state Eurasian Economic Union has advanced considerably in recent months – on the sticky issue of Quality Management Systems (QMS) and on the readiness of Russian labs to sign up to the system. There is no turning back now that the system has been declared user-ready.

A recent agreement on quality management systems (QMS) was the last of the second-level Eurasian Economic Union (EAEU) requirements needed before the EAEU medical devices regulatory system can be used in practice. This major, essential piece of the EAEU medical device system that tells manufacturers how to comply with QMS for the whole region was published as a Decision by the Eurasian Commission in October.

QMS is the last of the 13 second-level documents/requirements number. And the timeframe for two of the 10 third-level documents...