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Russian Regulators Publish New Medical Device Nomenclature System

Posted 20 January 2015 | By Stewart Eisenhart 

Russian Regulators Publish New Medical Device Nomenclature System

Content provided by Emergo, a medical device regulatory affairs and quality assurance consulting firm with offices worldwide.

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 more closely to those of other device markets.

The 19 new categories include:

Anesthetic and respiratory devicesOphthalmic devices
General and hospital-use devicesRadiological devices
Gastrointestinal devicesDevices for rehabilitation
Obstetrics and gynecology devicesCardiovascular devices
In vitro diagnostic (IVD) devicesDental devices
Devices for tissue and organ handling/recoveryUrology devices
ENT devicesPhysiotherapy devices
Devices for cosmetology and dermatologySurgical instruments and systems
Neurological devicesEndoscopic devices
Orthopedic devices 

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.

 

Original Post on Emergo Blog

Related Post: Russian Regulators Preparing New Medical Device Classification System?


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