Human factors engineering (HFE) efforts are becoming a regulatory necessity for medical device companies in markets around the world. Combination product manufacturers face some unique...
New Medical Device Regulations Implemented in Russia
Russian regulators have reportedly published long-awaited changes to the country's regulatory process for medical devices.
The revised regulations took effect January 1, 2013, according to Russian medical device regulator Rozsdravnadzor. Emergo has been anticipating announcement of these changes, and will provide a more detailed evaluation of these requirements following thorough analysis. We will keep you posted of further details as we learn them.
Among possible changes to Russian medical device regulations previously reported by Emergo are new testing sample import permit, expert device review and clinical testing requirements.
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