New Medical Device Classifier Complicating Russian Registrations
Content provided by Emergo, a medical device regulatory affairs and quality assurance consulting firm with offices worldwide.
A new medical device nomenclature system launched and enforced by Russian regulators is causing challenges for registrants due to incomplete and missing codes, as well as more stringent requirements for grouping products together in the same registration.
Roszdravnadzor’s Nomenclature Classification of Medical Devices by Type (link in Russian) includes 19 general device types, with more specific codes and definitions within each category. Starting January 15th 2015, all Russian marketing authorization applications must include type of medical device, according to the new system. Since the new nomenclature list does not include all device types, already lengthy Roszdravnadzor registration-related activities may be further delayed, according to Emergo consultants in Moscow.
The issue has not gone over well with medical device companies; to address industry concerns, Roszdravnadzor has begun accepting suggestions for additions to its nomenclature list via email.
We’ll report on any changes to the process as soon as we learn them.
Related Post: Russian Regulators Preparing New Medical Device Classification System?
Related Post: Possible Thaw in Russian Medical Device Regulations?