Russian Regulators Publish New Medical Device Nomenclature System
Posted 20 January 2015 | By
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 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 cosmetology and dermatology||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.
Original Post on Emergo Blog
Related Post: Russian Regulators Preparing New Medical Device Classification System?