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ANVISA Clarifies the Use of Smartwatches for Measuring Blood Glucose

These devices are not suitable for glycemic control.

ANVISA Clarifies the Use of Smartwatches for Measuring Blood Glucose and Oximetry

ANVISA has published a technical note regarding the use of smartwatches for measuring parameters such as blood glucose (blood sugar level) and oximetry (blood oxygen saturation).

The Technical Note 12/2024/SEI/GQUIP/GGTPS/DIRE3/ANVISA specifies that any device performing measurements commonly considered medical must be regulated by the Agency. Some examples include measurements of blood glucose, oximetry, blood pressure, electrocardiogram, and detection of irregular heart rhythm.

Currently, five software applications for smartwatches are approved by ANVISA. They are authorized to measure blood pressure, perform electrocardiograms, and detect irregular heart rhythms. However, no such devices are regulated for non-invasive measurement of glucose or oximetry at this time.

This is due to the lack of robust studies proving the safety and performance of these devices for such uses. The products regulated by the Agency can be consulted on the website: https://consultas.anvisa.gov.br/#/saude/

Devices that measure only heart rate and respiratory rate, considered for non-strictly medical use, do not need regulation by ANVISA.




If advertisements for smartwatches and accessories claim to measure blood glucose non-invasively and suggest their use for glycemic control, they should be reported to ANVISA.

Check the Agency’s contact channels.

The sale of unregulated medical devices is a sanitary infraction subject to penalties under Law 6.437/1977.


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The regulatory process for a medical device aims to ensure that the manufacturer provides evidence of the product’s safety and performance for its intended uses.

This proof requires studies with rigorous scientific methodology, showing that the device consistently achieves the proposed objectives. The companies responsible for the regulated software conducted extensive studies and performance tests.

Non-invasive blood glucose measurement by smartwatches and accessories is a developing technology and has not undergone the regulatory process. The accuracy of medical devices evaluated by ANVISA is crucial, as errors can result in incorrect insulin dosages, leading to serious consequences such as glycemic shock or worsening health conditions due to inadequate diabetes control.