Distribution date: 11 April 2022 | Final date for Comment: 06 May 2025

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 | Final date for Comment: 06 May 2025

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 | Final date for Comment: 06 May 2025

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 | Final date for Comment: 06 May 2025

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 | Final date for Comment: 06 May 2025

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 | Final date for Comment: 06 May 2025

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 | Final date for Comment: 06 May 2025

This resolution defines criteria and procedures extraordinary and temporary for the manufacturing and marketing of antiseptic preparations or workshop sanitizers without prior notice authorization from Anvisa and gives other measures in view of the emergency international public health related to SARS-CoV-2.

Products Covered: HS (3003, 3004, 3303, 3304, 3305, 3306, 3307, 3402) - Medicaments, sanitizers, and cosmetics.

Regulation Type: Regular notification

Distribution date: 11 April 2022 | Final date for Comment: 06 May 2025

This resolution defines criteria and procedures extraordinary and temporary for the manufacturing and marketing of antiseptic preparations or workshop sanitizers without prior notice authorization from Anvisa and gives other measures in view of the emergency international public health related to SARS-CoV-2.

Products Covered: HS (3003, 3004, 3303, 3304, 3305, 3306, 3307, 3402) - Medicaments, sanitizers, and cosmetics.

Regulation Type: Regular notification

Distribution date: 11 April 2022 | Final date for Comment: 06 May 2025

This resolution contains provisions on the regularization of disposable personal hygiene products intended for body cleaning, which include brushes and sticks for oral hygiene, dental floss and tape, disposable sanitary pads, menstrual cups and flexible swabs.

Products Covered: HS (3303, 3304, 3305, 3306, 3307) - Personal hygiene products

Regulation Type: Regular notification

Distribution date: 11 April 2022 | Final date for Comment: 06 May 2025

This resolution contains provisions on the regularization of disposable personal hygiene products intended for body cleaning, which include brushes and sticks for oral hygiene, dental floss and tape, disposable sanitary pads, menstrual cups and flexible swabs.

Products Covered: HS (3303, 3304, 3305, 3306, 3307) - Personal hygiene products

Regulation Type: Regular notification