By Stewart Eisenhart, Emergo Group
Russian medical device market regulators have eased registration and market entry requirements for low-risk Class I devices, while at the same time formalizing procedures for certain registration amendments and changes to Instructions for Use (IFU).
Less complex registration for Class I devices
First, under Order 303n (link in Russian), Class I devices submitted to Russian medical device regulator, Roszdravnadzor, will only undergo one round of quality and safety review; previously, Class I devices underwent two phases of review just like higher-risk Class IIa, IIb, and III devices do.
Although the new rules exempt Class I device manufacturers from Russian “clinical trial” requirements (“clinical trial” in Russia refers to clinical data and/or an actual clinical trial conducted in Russia), manufacturers must still provide clinical reports and related data in their registration documents to Roszdravnadzor.
Stricter change and amendment approval process
Also according to Order 303n, companies whose devices are already registered and who would like to amend their IFU or technical documentation now face additional requirements in order to make these changes. These modification requests will need to be reviewed by an Expertise Center (similar to new device registrations), which may drive up costs for manufacturers and result in longer approval timeframes for changed and amended device registrations.
The new Class I registration pathway and requirements for amendments went into force July 17, 2015.
Emergo consultants in Russia and Europe will continue monitoring these latest developments from Roszdravnadzor and provide additional details as we learn them.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.