Dear Claudia,
Thank you for posting. I have read through it, and my experience with other non-medical regulatory this strikes me as most important for consumer and general electrical products, (e.g. household appliances, Computer IT and AV equipment, switches, plugs, etc.) It is my assessment that this does not apply to Medical Devices. However, compliance into Russia is not an area of high degree of expertise.
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Thomas M. Heckmann, P.E.
Regulatory Manager
Reichert Inc
Depew NY
United States
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Original Message:
Sent: 02-02-2015 10:13
From: Claudia Meneghisse
Subject: Eurasian Conformity (EAC) mark for Medical Devices in Russia, Belarus and Kazaksthan
Dear collegues,
Does anybody knows if the EAC mark is required for electric medical devices / IVD for Russia, Belarus and Kazakstan? Is it mandatory or optional? How to get this mark?
I'm referring to Customs Technical Regulation 020/2011 (attached). Any regulation or clarification on this topic would be helpful.
Thanks and Kind Regards,
Claudia
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Claudia Meneghisse PHD, RAC
Switzerland
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