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Mobile Health Apps — When ANVISA Regulates

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ANVISA has been working to clarify when mobile health applications (aplicativos de saúde or mHealth apps) qualify as medical devices requiring ANVISA registration. The regulatory position is similar to the FDA's and EU MDR's approach — based on the intended purpose of the app.

Apps that ARE medical devices (require ANVISA registration)​

  • Apps that analyse clinical data (ECG, skin lesion images, retinal images) to diagnose disease;
  • Apps that provide clinical decision support that directly drives clinical management decisions (not just general information);
  • Apps that control or monitor a medical device (e.g., apps controlling an insulin pump);
  • Apps that calculate drug dosing based on patient-specific clinical parameters for a named medication and patient condition; and
  • Apps intended to replace a clinical diagnostic tool.

Apps that are NOT medical devices (no ANVISA registration required)​

  • General wellness and fitness apps (step counters, calorie trackers) with no diagnostic or therapeutic claims;
  • Administrative apps (appointment booking, patient communication) with no clinical decision functions;
  • Educational medical apps for healthcare professional training; and
  • Apps providing general health information or condition education without personalised recommendations.

The intended purpose test​

The key question is: does the app make or support a clinical decision for a specific patient? If yes, it is likely a medical device. If it only provides general health information, it is likely not.

If uncertain, submit a consulta de enquadramento (classification inquiry) to ANVISA.

Official sources

Verify all information against official ANVISA sources before making regulatory decisions.