SaMD & Software Classification
Background
Roszdravnadzor published methodological guidelines in 2018 on the registration and classification of standalone software as a medical device. This was the first formal Russian guidance establishing when software qualifies as a medical device and how it should be classified.
When software is a medical device
Software qualifies as a medical device in Russia when its intended purpose, as stated by the manufacturer, is to be used for one or more of the following:
- Diagnosing, monitoring, treating, or preventing disease
- Analyzing clinical images for diagnostic purposes
- Supporting clinical decision-making in relation to individual patients
General-purpose software, administrative tools, and software that does not itself provide a clinical output for individual patients is generally not considered a medical device.
Classification of software
Software classified as a medical device is assigned a risk class (I, IIa, IIb, or III) based on the same risk criteria applied to hardware devices — primarily the intended use and the potential harm caused by failure or error. Software supporting high-risk clinical decisions (e.g., AI-based diagnostic tools for oncology) will typically fall in Class IIb or III.
OKPD-2 codes for software
Software medical devices must have an assigned OKPD-2 code. The official OKPD-2 list was updated in 2017–2018 to add more than 90 new codes, including codes for software devices.
Practical notes
- The technical documentation for a software medical device must include a software description, version control information, and cybersecurity risk assessment
- AI/ML-based software follows the same framework but may receive additional scrutiny during expert review
- See the Digital Health & SaMD section for more detail
Roszdravnadzor methodological guidelines on medical software (2018): roszdravnadzor.gov.ru