Jan 19, 2015

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:

  • Anesthetic and respiratory devices
  • Ophthalmic devices
  • General and hospital-use devices
  • Radiological devices
  • Gastrointestinal devices
  • Devices for rehabilitation
  • Obstetrics and gynecology devices
  • Cardiovascular devices
  • In vitro diagnostic (IVD) devices
  • Dental devices
  • Devices for tissue and organ handling/recovery
  • Urology devices
  • ENT devices
  • Physiotherapy devices
  • Devices for cosmology and dermitology
  • Surgical instruments and systems
  • Neurological devices
  • Endoscopic 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.

 

Author

  • Stewart Eisenhart

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Russian Regulators Preparing New Medical Device Classification System?

Roszdravnadzor, the Russian medical device market regulator, has announced plans 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.

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