Resolution – RDC number 375, 17 April 2020
Distribution date: 11 June 2020 | Final date for Comment: 11 May 2025
This resolution extraordinarily and temporarily establishes the submission procedure for clinical studies required to validate medical devices of Classes III and IV identified as essential to healthcare services, due to the international public health emergency related to the SARS-CoV-2.
Products Covered: HS Code(s): medical devices (2936, 2937, 3001, 3002, 3003, 3004, 3006)
Regulation Type: Regular notification
The Resolution – RDC number 356, 23 March 2020 – previously notified through G/TBT/N/BRA/993 – which establishes exceptional criteria and procedure for the manufacturing, import, and acquisition of medical devices identified as indispensable for the use in healthcare services due to the international public health emergency related to the SARS-CoV-2, was changed by the Resolution – RDC number 379, 30 April 2020. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 12 June 2020 | Final date for Comment: 11 May 2025
Products Covered: HS Code(s): 2936, 2937, 3001, 3002, 3003, 3004, 3006 (medical devices)
Regulation Type: Addendum to Regular Notification
The Resolution – RDC number 356, 23 March 2020 – previously notified through G/TBT/N/BRA/993 – which establishes exceptional criteria and procedure for the manufacturing, import, and acquisition of medical devices identified as indispensable for the use in healthcare services due to the international public health emergency related to the SARS-CoV-2, was changed by the Resolution – RDC number 379, 30 April 2020. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 12 June 2020 | Final date for Comment: 11 May 2025
Products Covered: HS Code(s): 2936, 2937, 3001, 3002, 3003, 3004, 3006 (medical devices)
Regulation Type: Addendum to Regular Notification
Protection of Stratospheric Ozone: Listing of Substitutes Under the Significant New Alternatives Policy Program
Distribution date: 15 June 2020 | Final date for Comment: 27 July 2020
Notice of proposed rulemaking - Pursuant to the U.S. Environmental Protection Agency's (EPA) Significant New Alternatives Policy program, this action proposes to list certain substances in the refrigeration and air conditioning sector and the foam blowing sector. For the retail food refrigeration-- medium-temperature stand-alone units (new) end-use, EPA is proposing to list substitutes as acceptable subject to narrowed use limits. For the residential and light commercial air conditioning and heat pumps (new) end-use, EPA is proposing to list substitutes as acceptable subject to use conditions. For the foam blowing sector, extruded polystyrene: Boardstock and billet end-use, EPA is proposing to list substitutes as acceptable. This action also proposes to remove an acceptable subject to use conditions listing for the fire suppression sector because EPA more recently listed the substitute as acceptable with no use restrictions.
Products Covered: Chemical substances
Regulation Type: Regular notification
Protection of Stratospheric Ozone: Listing of Substitutes Under the Significant New Alternatives Policy Program
Distribution date: 15 June 2020 | Final date for Comment: 27 July 2020
Notice of proposed rulemaking - Pursuant to the U.S. Environmental Protection Agency's (EPA) Significant New Alternatives Policy program, this action proposes to list certain substances in the refrigeration and air conditioning sector and the foam blowing sector. For the retail food refrigeration-- medium-temperature stand-alone units (new) end-use, EPA is proposing to list substitutes as acceptable subject to narrowed use limits. For the residential and light commercial air conditioning and heat pumps (new) end-use, EPA is proposing to list substitutes as acceptable subject to use conditions. For the foam blowing sector, extruded polystyrene: Boardstock and billet end-use, EPA is proposing to list substitutes as acceptable. This action also proposes to remove an acceptable subject to use conditions listing for the fire suppression sector because EPA more recently listed the substitute as acceptable with no use restrictions.
Products Covered: Chemical substances
Regulation Type: Regular notification
The Resolution – RDC number 346, 12 March 2020 – previously notified through G/TBT/N/BRA/984 – which establishes extraordinary and temporary criteria and procedure for Good Manufacture Practice Guidelines for market authorization and post-market registration amendments of Active Pharmaceutical Ingredients, medicines, and healthcare products due to the international public health emergency of the new coronavirus (Covid-19), was changed by the Resolution – RDC number 385, 12 May 2020. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 15 June 2020 | Final date for Comment: 11 May 2025
Products Covered: HS Code(s): 29, 2936, 2937, 2941, 30, 3001, 3002, 3003, 3004, 3005, 3006. (pharmaceutical products, active pharmaceutical ingredients, and healthcare products)
Regulation Type: Addendum to Regular Notification
The Resolution – RDC number 346, 12 March 2020 – previously notified through G/TBT/N/BRA/984 – which establishes extraordinary and temporary criteria and procedure for Good Manufacture Practice Guidelines for market authorization and post-market registration amendments of Active Pharmaceutical Ingredients, medicines, and healthcare products due to the international public health emergency of the new coronavirus (Covid-19), was changed by the Resolution – RDC number 385, 12 May 2020. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 15 June 2020 | Final date for Comment: 11 May 2025
Products Covered: HS Code(s): 29, 2936, 2937, 2941, 30, 3001, 3002, 3003, 3004, 3005, 3006. (pharmaceutical products, active pharmaceutical ingredients, and healthcare products)
Regulation Type: Addendum to Regular Notification
The Resolution – RDC number 301, 21 August 2019 – previously notified through G/TBT/N/BRA/870 – which adopts the Guide to Good Manufacturing Practices for Medicinal Products of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) of 1 July 2018, was rectified. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 15 June 2020 | Final date for Comment: 11 May 2025
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
The Resolution – RDC number 301, 21 August 2019 – previously notified through G/TBT/N/BRA/870 – which adopts the Guide to Good Manufacturing Practices for Medicinal Products of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) of 1 July 2018, was rectified. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 15 June 2020 | Final date for Comment: 11 May 2025
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
The Resolution – RDC number 301, 21 August 2019 – previously notified through G/TBT/N/BRA/870 – which adopts the Guide to Good Manufacturing Practices for Medicinal Products of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) of 1 July 2018, was rectified. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 15 June 2020 | Final date for Comment: 11 May 2025
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
Submit your email ID to receive notifications about upcoming courses and events
