ORBIS Compliance

Brazil's ANVISA bans glucose-measuring smartwatches due to lack of scientific support

Published /Effective /Brazil

Brazil's National Health Surveillance Agency (ANVISA) has officially banned the marketing, distribution, importation, advertising, and use of the "Glicowatch," a manufactured smartwatch that claimed to be able to measure glucose and monitor blood pressure.

This measure was taken on August 4, 2025, after it was found that the device was being sold on online platforms without the proper health registration with the regulatory agency.

ANVISA's decision is based on the lack of scientific evidence supporting the effectiveness of the Glicowatch. According to the agency, these devices have not undergone rigorous clinical studies demonstrating their real ability to measure blood glucose levels, something essential for people with diabetes.

WHOM DOES IT IMPACT?

The direct impact is on manufacturers, importers, and marketers of medical devices, as well as patients.

CONCLUSION:

ANVISA's action reinforces the need for strict oversight of technological products that promise medical functions without scientific backing.

Furthermore, it protects the population from potential health risks resulting from the use of unregulated devices.

Regulatory Authority

ANVISA

Regulatory Impact

Impact TypeStatus
Top Priority
Type Certificate
Spectrum Bands
Import Changes (HS Codes)
Standard Changes
Product Changes
Label Changes

Brazil Quick Facts

Regulatory AgencyANATEL (Agência Nacional de Telecomunicações)
Certification TypeMandatory
License ValidityTechnical compliance certificate: 2 to 3 years
Application LanguagePortuguese
Legal License HolderRequired
In-country Testing RequirementRequires testing

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