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mHealth Apps — When Registration is Required

The core question​

Not all mobile health apps are medical devices. The key question is whether the app, as intended by its manufacturer, performs a function that falls within the definition of a medical device under Article 38 of Federal Law 323-FZ.

Apps that ARE likely medical devices​

  • Apps that analyse ECG, blood glucose, or other clinical data from a connected sensor and provide a diagnostic interpretation
  • Apps that provide patient-specific treatment recommendations
  • Apps that analyse medical images (X-ray, MRI, retinal images) and output diagnostic findings
  • Apps that monitor vital signs in clinical settings and generate clinical alerts

Apps that are likely NOT medical devices​

  • General wellness and fitness tracking apps with no diagnostic claims
  • Health education apps
  • Apps that store and display health data without interpreting it
  • Administrative healthcare apps (appointment booking, insurance claims)

The grey area​

Consumer health apps with indirect clinical relevance — such as apps monitoring sleep patterns, stress levels, or menstrual cycles — occupy a grey area. If the manufacturer makes no diagnostic claims and the app is not intended to influence clinical decisions, it is unlikely to be a medical device. If clinical claims are made, registration may be required.

Practical steps​

  1. Review your app's intended purpose as stated in the product literature and app store description
  2. Apply the criteria from Roszdravnadzor's 2018 methodological guidelines
  3. If uncertain, seek a formal classification opinion from Roszdravnadzor (or your RUS REP)
  4. If classified as a medical device, proceed with registration under the applicable class
Official source

Roszdravnadzor methodological guidelines on medical software (2018): roszdravnadzor.gov.ru