Proyecto de Reglamento de la Ley Nº 27645, Ley que Regula la Comercialización de Alcohol Metílico y de la Ley Nº 28317, Ley de Control y Fiscalización de la Comercialización del Alcohol Metílico (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) (24 pages, in Spanish)
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
Regularization process of medical devices at ANVISA, pursuant to the Collegiate Board Resolution - RDC No. 340, of March 6, 2020
Distribution date: 09 October 2020 | Final date for Comment: 15 May 2025
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
Regularization process of medical devices at ANVISA, pursuant to the Collegiate Board Resolution - RDC No. 340, of March 6, 2020
Distribution date: 09 October 2020 | Final date for Comment: 15 May 2025
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
TDC 9(6785) P3 Textiles – Reusable fabric face masks – Specification
Distribution date: 12 October 2020 | Final date for Comment: 11 December 2020
This Draft Tanzania Standard specifies performance requirements, sampling and test methods for reusable fabric face masks for general public use.
Products Covered: Reusable fabric face masks
Regulation Type: Regular notification
TDC 9(6785) P3 Textiles – Reusable fabric face masks – Specification
Distribution date: 12 October 2020 | Final date for Comment: 11 December 2020
This Draft Tanzania Standard specifies performance requirements, sampling and test methods for reusable fabric face masks for general public use.
Products Covered: Reusable fabric face masks
Regulation Type: Regular notification
Resolution - RE number 3837, 24 September 2020
Distribution date: 12 October 2020 | Final date for Comment: 15 May 2025
The Draft Resolution number 864, 7 July 2020 - previously notified through G/SPS/N/BRA/1731 - was adopted as Resolution - RE number 3837, 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=578
Products Covered:
Regulation Type: Addendum to Regular Notification
Resolution - RE number 3837, 24 September 2020
Distribution date: 12 October 2020 | Final date for Comment: 15 May 2025
The Draft Resolution number 864, 7 July 2020 - previously notified through G/SPS/N/BRA/1731 - was adopted as Resolution - RE number 3837, 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=578
Products Covered:
Regulation Type: Addendum to Regular Notification
TDC 9(6784) P3 Textiles – Surgical face masks – Specification
Distribution date: 12 October 2020 | Final date for Comment: 11 December 2020
This Draft Tanzania Standard specifies the performance requirements, sampling and test methods of surgical face masks intended to limit the transmission of infective agents from staff to patients and (in certain situations) vice-versa during surgical procedures in operating theatres and other health care services such as patient care, with similar requirements.This Draft Tanzania Standard is not applicable to masks intended exclusively for the personal protection of staff.
Products Covered: Surgical face masks
Regulation Type: Regular notification
TDC 9(6784) P3 Textiles – Surgical face masks – Specification
Distribution date: 12 October 2020 | Final date for Comment: 11 December 2020
This Draft Tanzania Standard specifies the performance requirements, sampling and test methods of surgical face masks intended to limit the transmission of infective agents from staff to patients and (in certain situations) vice-versa during surgical procedures in operating theatres and other health care services such as patient care, with similar requirements.This Draft Tanzania Standard is not applicable to masks intended exclusively for the personal protection of staff.
Products Covered: Surgical face masks
Regulation Type: Regular notification
Amendment of the ANVISA Collegiate Board Resolution - RDC No. 350 of 19 March 2020.
Distribution date: 13 October 2020 | Final date for Comment: 15 May 2025
The Resolution – RDC number 350, 19 March 2020 – previously notified through G/TBT/N/BRA/989 – which establishes exceptional criteria and procedure for the manufacturing and sale of antiseptic preparations and sanitizers without previous market authorization from ANVISA and provides other measures due to the international public health emergency related to the SARS-CoV-2, was changed by the Resolution – RDC number 422, 16 September 2020.
Products Covered: HS Code(s): 33079090, 38089990, 3402 (antiseptic preparations, sanitizer)
Regulation Type: Addendum to Regular Notification
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