Distribution date: 09 October 2020

The Normative Instruction number 61, 6 March 2020 – previously notified through G/TBT/N/BRA/940/Add.1 – which establishes the topics for the changing of information presented in the process of market authorization of medical devices in ANVISA, was changed by the Normative Instruction number 74, 16 September 2020.

Products Covered: HS Code(s): 2936, 2937, 3001, 3002, 3003, 3004, 3006 (medical devices)

Regulation Type: Addendum to Regular Notification

Distribution date: 09 October 2020

The Normative Instruction number 61, 6 March 2020 – previously notified through G/TBT/N/BRA/940/Add.1 – which establishes the topics for the changing of information presented in the process of market authorization of medical devices in ANVISA, was changed by the Normative Instruction number 74, 16 September 2020.

Products Covered: HS Code(s): 2936, 2937, 3001, 3002, 3003, 3004, 3006 (medical devices)

Regulation Type: Addendum to Regular Notification

Distribution date: 09 October 2020 | Final date for Comment: 08 December 2020

The notified draft regulations implementing Law No. 27645 regulating the marketing of methyl alcohol and Law No. 28317 on the control and monitoring of the marketing of methyl alcohol seek to establish the regulatory provisions for both laws. The draft regulations set out specifications and procedures for controlling and monitoring the marketing of methyl alcohol from the time of its manufacture or entry into the country through to when it reaches its final destination, with a view to preventing this type of product, which is harmful to health, from being diverted towards unlawful and informal activities, such as the production of alcoholic beverages containing methyl alcohol.

Products Covered: Methanol "methyl alcohol" (HS code(s): 290511); Alcohols. Ethers (ICS code(s): 71.080.60)

Regulation Type: Regular notification

Distribution date: 09 October 2020 | Final date for Comment: 08 December 2020

The notified draft regulations implementing Law No. 27645 regulating the marketing of methyl alcohol and Law No. 28317 on the control and monitoring of the marketing of methyl alcohol seek to establish the regulatory provisions for both laws. The draft regulations set out specifications and procedures for controlling and monitoring the marketing of methyl alcohol from the time of its manufacture or entry into the country through to when it reaches its final destination, with a view to preventing this type of product, which is harmful to health, from being diverted towards unlawful and informal activities, such as the production of alcoholic beverages containing methyl alcohol.

Products Covered: Methanol "methyl alcohol" (HS code(s): 290511); Alcohols. Ethers (ICS code(s): 71.080.60)

Regulation Type: Regular notification

Distribution date: 07 October 2020

The Draft Resolution number 865, 7 July 2020 - previously notified through G/SPS/N/BRA/1732 - was adopted as Resolution - RE number 3847, 24 September 2020. The full text is available only in Portuguese and can be downloaded at:https://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?data=28/09/2020&jornal=515&pagina=579

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 07 October 2020

The Draft Resolution number 865, 7 July 2020 - previously notified through G/SPS/N/BRA/1732 - was adopted as Resolution - RE number 3847, 24 September 2020. The full text is available only in Portuguese and can be downloaded at:https://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?data=28/09/2020&jornal=515&pagina=579

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 06 October 2020

This Resolution changes the Resolution – RDC number 27, 21 June 2011, the Resolution – RDC number 36, 26 August 2015, and the Resolution – RDC number 40, 26 August 2015; and establishes the cancellation of the registration system for medical devices classified as Risk I and II classes, which must be registered in the notification regime.

Products Covered: Provitamins and vitamins, natural or reproduced by synthesis (including natural concentrates), derivatives thereof used primarily as vitamins, and intermixtures of the foregoing, whether or not in any solvent. (HS code(s): 2936); Hormones, natural or reproduced by synthesis; derivatives thereof, used primarily as hormones; other steroids used primarily as hormones. (HS code(s): 2937); Pharmaceutical products (HS code(s): 30); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Regular notification

Distribution date: 06 October 2020

This Resolution changes the Resolution – RDC number 27, 21 June 2011, the Resolution – RDC number 36, 26 August 2015, and the Resolution – RDC number 40, 26 August 2015; and establishes the cancellation of the registration system for medical devices classified as Risk I and II classes, which must be registered in the notification regime.

Products Covered: Provitamins and vitamins, natural or reproduced by synthesis (including natural concentrates), derivatives thereof used primarily as vitamins, and intermixtures of the foregoing, whether or not in any solvent. (HS code(s): 2936); Hormones, natural or reproduced by synthesis; derivatives thereof, used primarily as hormones; other steroids used primarily as hormones. (HS code(s): 2937); Pharmaceutical products (HS code(s): 30); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Regular notification

Distribution date: 05 October 2020 | Final date for Comment: 16 October 2020

This Draft Resolution establishes the market authorization, inclusion and revising of the housecleaning use for the active ingredients A20 – AZAMETIFÓS, C82 – COLECALCIFEROL, D06 – DELAMETRINA, D13 – DICLORVÓS, D55 – DINOTEFURAN, M50 – MONFLUOROTRINA, and T48 – TIAMETOXAM. 

Products Covered: HS 340119

Regulation Type: Regular notification

Distribution date: 05 October 2020 | Final date for Comment: 16 October 2020

This Draft Resolution establishes the market authorization, inclusion and revising of the housecleaning use for the active ingredients A20 – AZAMETIFÓS, C82 – COLECALCIFEROL, D06 – DELAMETRINA, D13 – DICLORVÓS, D55 – DINOTEFURAN, M50 – MONFLUOROTRINA, and T48 – TIAMETOXAM. 

Products Covered: HS 340119

Regulation Type: Regular notification