When you make design changes to an existing medical device, requirements in most major markets indicate you must notify the regulatory authority of your change...
Russian Regulators Publish New Medical Device Nomenclature System
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Roszdravnadzor, Russia’s medical device market regulator, has published a new system for nomenclature classification according to 19 different device types.
The categories (link in Russian) appear to be based on Global Medical Device Nomenclature (GMDN), which could suggest that Roszdravnadzor will realign its market registration requirements closer to those of other device markets.
The 19 new categories include:
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Although medical device regulation in Russia remains highly opaque and challenging, Roszdravnadzor’s release of its new classification system hopefully indicates a sustained and successful effort to allow more transparency and efficiency into the market’s approval process.
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