Anvisa's Warning on Smart Digital Watches
Anvisa (National Health Surveillance Agency) published, on 02/23/24, a technical note warning about the risks associated with using smart digital watches to measure blood glucose (sugar level) and oximetry (blood oxygen saturation). According to the text, there is, to date, no regularized device that guarantees accuracy and safety.
The public health department explained that there are still no studies with robust evidence on the performance of the devices for this indication. The sale of medical devices without proper regularization is considered a health infraction, with penalties provided for by Law No. 6,437/77.
Currently, five software programs for smartwatches are approved by Anvisa. They are intended for measuring blood pressure, electrocardiograms, and irregular heart rhythm notifications. None of these programs include non-invasive glucose measurement or oximetry.
Additionally, the agency emphasizes that devices measuring only heart and respiratory rates, which are not strictly considered for medical use, are not subject to regulation.
Anvisa recommends that patients requiring monitoring of their blood glucose or oximetry use traditional medical devices, duly regulated by the department.
Regulatory Impact
| Impact Type | Status |
|---|---|
| Top Priority | |
| Type Certificate | |
| Spectrum Bands | |
| Import Changes (HS Codes) | |
| Standard Changes | |
| Product Changes | |
| Label Changes |