- Should medical software be registered in Russia?
Yes, according to clause #2 of Russian medical device registration rules (Decree 1416, link in Russian), special medical software is covered by the definition of a medical device and must be registered prior to market access.
- Should medical software be registered in a separate registration certificate or together with another device for which it is intended?
Roszdravnadzor (Russian medical device regulator) did not provide clear guidelines on this point up to now. However, if you undertake some brief research in the state medical device register (Roszdravnadzor`s national database of approved medical devices), it is apparent that, since new registration rules were enforced in January 2013, medical software was mentioned in 258 Russian registration certificates. Of this number, absolutely the major part of software was registered as a component or as an accessory to other medical devices (e.g. computerised tomography systems, ultrasound and X-ray devices…). I could find only four cases since this period when medical software was registered as a separate medical product (separate registration certificate).
It should be noted that, since the beginning of 2015, a new medical device nomenclature classifier has been enforced. In the current version of this classification there are more than 150 codes devoted to medical software depending on its intended use.
- Should a version of software be indicated in the registration submission?
Roszdravnadzor recommends including the name and the version of the software in the registration application form. Even if medical software is submitted for registration together or as a part of another medical device, its version and release date should be mentioned in the technical file in the registration dossier. If several versions are mentioned in the description of a medical device, each modification of software should be identified by name, version and release date. Based on recent feedback from the Russian regulator, lack of detailed identification of software is a typical and one of the most common reasons for additional requests and delays during registration expertise in the last year.
- What should be done if the software has been upgraded after a product is registered?
Upgrade of the software requires notification of Roszdravnadzor (see clause #55 of Decree 1416, link in Russian ). After this notification, then regulator will make a decision; if such an upgrade requires identification of a new software version and if a procedure of revision/renewal of technical documentation of a medical device is necessary. Usually, minor changes and bug fixes will not require further regulatory actions after the notification.
- What are the main regulations?
-Russian National Standard GOST R ISO/MEC 12119:2000 (link in Russian)
-Federal Law 102-FZ dated 26.06.2008 (clauses 3.2 and 4.2.5) (link in Russian)
-WELMEC 7.2 Issue 4 (measuring Instrument Directive 2004/22/EC)