ANVISA Ban on Mercury Devices

The Collective Board of the National Health Surveillance Agency (ANVISA) has enacted a resolution prohibiting the manufacture, importation, sale, and use of mercury column thermometers and sphygmomanometers across Brazil. This decision was reached during a meeting on September 18, 2024, and the resolution will take effect on September 19, 2024.

Mercury column thermometers and sphygmomanometers, designed for measuring body temperature and blood pressure, respectively, are now banned due to health concerns. However, this prohibition does not extend to products used for research, calibration, or as reference standards.

All affected products must be managed in accordance with Resolution RDC No. 222, dated March 28, 2018, which governs Good Practices for the Management of Health Services Waste. Non-compliance with this new resolution will be considered a health infraction under Law No. 6,437, dated August 20, 1977, and may result in civil, administrative, and criminal penalties.

Additionally, Resolution RDC No. 145, published on March 22, 2017, has been repealed.

Regulatory Impact

• Top Priority: Yes
• Type of Certificate: No
• Spectrum Bands: No
• Import Changes HS Codes: No
• Standard Changes: No
• Product Changes: Yes
• Label Changes: No

Link to Source - https://antigo.anvisa.gov.br/legislacao#/visualizar/524710