Regulatory Updates
Resolution – RDC number 665, 30 March 2022

Distribution date: 11 April 2022
This resolution contains provisions on Good Manufacturing Practices for Medical Devices and In Vitro Diagnostic Products.This resolution incorporates into the national legal system the Resolution of MERCOSUR (GMC) number 20, 17 November 2011, MERCOSUR/GMC/RES. nº 20/11, "MERCOSUR Technical Regulation on Good Manufacturing Practices for Medical Devices and In Vitro Diagnostic Products”.
Products Covered: HS (3006) - Medical Devices
Regulation Type: Regular notification
Resolution – RDC number 654, 24 March 2022

Distribution date: 11 April 2022
This resolution contains provisions on Good Manufacturing Practices for Active Pharmaceutical Ingredients.
Products Covered: HS (3006) - Active Pharmaceutical Ingredients
Regulation Type: Regular notification
Resolution – RDC number 654, 24 March 2022

Distribution date: 11 April 2022
This resolution contains provisions on Good Manufacturing Practices for Active Pharmaceutical Ingredients.
Products Covered: HS (3006) - Active Pharmaceutical Ingredients
Regulation Type: Regular notification
Resolution – RDC number 640, 24 March 2022

Distribution date: 11 April 2022
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
Resolution – RDC number 640, 24 March 2022

Distribution date: 11 April 2022
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
Resolution – RDC number 641, 24 March 2022

Distribution date: 11 April 2022
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
Resolution – RDC number 641, 24 March 2022

Distribution date: 11 April 2022
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
Resolution – RDC number 649, 24 March 2022

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
Resolution – RDC number 649, 24 March 2022

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
Resolution – RDC number 650, 25 March 2022

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
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