Regulatory

Russian regulators preparing new medical device classification system?

The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you’ll enjoy the content.

By Stewart Eisenhart, Emergo Group

Roszdravnadzor, the Russian medical device market regulator, has announcedplans (link in Russian) to develop a new device classification system based on Global Medical Device Nomenclature (GMDN), suggesting perhaps a regulatory approach more harmonized with international standards than previous Russian registration requirements.

Roszdravnadzor’s announcement includes a spreadsheet of more than 20,000 medical device types and descriptions. Regulators are accepting comments on the proposed system, but have not set firm deadlines or rollout dates as of yet.

Emergo Group’s Moscow office will continue monitoring the situation for additional details on Russian medical device regulatory reforms.

Stewart Eisenhart covers medical device regulatory affairs forEmergo Group.

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Josh Sandberg

Josh Sandberg is the President of Ortho Sales Partners and Partner for The De Angelis Group. He also serves as Co-Founder and Editor of OrthoSpineNews.

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