Regulatory Updates

Distribution date: 11 April 2022

This resolution establishes criteria and restrictions for marketing products that contain inhalant substances.

Products Covered: HS (32) - Glues, thinner, adhesives and correctors

Regulation Type: Regular notification

Distribution date: 11 April 2022

This resolution contains provisions on criteria for inclusion, exclusion and updating of sanitizing products with lower potential risk manufactured within the scope of MERCOSUR and incorporates GMC MERCOSUR number 51/2006.

Products Covered: HS (3402) - Sanitizing products

Regulation Type: Regular notification

Distribution date: 11 April 2022

This resolution contains provisions on criteria for inclusion, exclusion and updating of sanitizing products with lower potential risk manufactured within the scope of MERCOSUR and incorporates GMC MERCOSUR number 51/2006.

Products Covered: HS (3402) - Sanitizing products

Regulation Type: Regular notification

Distribution date: 11 April 2022

This resolution contains provisions on the regularization of software as a medical device (Software as a Medical Device - SaMD).The Medical Devices Technical Dossier Structure is aligned with the document issued by the International Medical Device Regulators Forum - IMDRF/RPS WG/N9 (Edition 3)

Products Covered: HS (3006) - Medical devices

Regulation Type: Regular notification

Distribution date: 11 April 2022

This resolution contains provisions on the regularization of software as a medical device (Software as a Medical Device - SaMD).The Medical Devices Technical Dossier Structure is aligned with the document issued by the International Medical Device Regulators Forum - IMDRF/RPS WG/N9 (Edition 3)

Products Covered: HS (3006) - Medical devices

Regulation Type: Regular notification

Distribution date: 11 April 2022

This resolution establishes general rules for personal hygiene products, cosmetics and perfumes manufactured in Brazil and destined exclusively for export.

Products Covered: HS (3303, 3304, 3305, 3306, 3307) - Toiletries, cosmetics and perfumes

Regulation Type: Regular notification

Distribution date: 11 April 2022

This resolution establishes general rules for personal hygiene products, cosmetics and perfumes manufactured in Brazil and destined exclusively for export.

Products Covered: HS (3303, 3304, 3305, 3306, 3307) - Toiletries, cosmetics and perfumes

Regulation Type: Regular notification

Distribution date: 11 April 2022

This resolution establishes conditions and criteria for the manufacture and sale of products called "carnival foam", "carnival snow", "artificial snow", "serpentine", "web", or any other similar denomination, presented in the form of an aerosol and which can come into direct contact with the skin, mucous membranes and/or eyes.

Products Covered: HS (3401) - "Carnival foam", "carnival snow", "artificial snow", "serpentine", "web", or any other similar denomination

Regulation Type: Regular notification

Distribution date: 11 April 2022

This resolution establishes conditions and criteria for the manufacture and sale of products called "carnival foam", "carnival snow", "artificial snow", "serpentine", "web", or any other similar denomination, presented in the form of an aerosol and which can come into direct contact with the skin, mucous membranes and/or eyes.

Products Covered: HS (3401) - "Carnival foam", "carnival snow", "artificial snow", "serpentine", "web", or any other similar denomination

Regulation Type: Regular notification

Distribution date: 11 April 2022

This resolution prohibits the manufacture, distribution or commercialization of products under sanitary surveillance that contain benzene in their composition, as a contaminating agent, in a percentage not exceeding 0.1% v/v.

Products Covered: HS (270710) - Benzol, Benzene

Regulation Type: Regular notification