Resolution number 692, 13 May 2022

Distribution date: 21 June 2022 | Final date for Comment: 04 May 2025
The article 9 of the Resolution - RDC number 692, 13 May 2022 - previously notified through G/TBT/N/BRA/1388 - which contains provisions on the procedure, fully electronic, for the notification to The Brazilian Health Regulatory Agency (ANVISA) , of Sanitation Products of Risk I, and on the validity of the records of Sanitation Products of Risk 2, was rectified. The rectified text is available only in Portuguese and can be downloaded at: https://www.in.gov.br/en/web/dou/-/retificacao-408491406
Products Covered: Organic surface-active agents (other than soap); surface-active preparations, washing preparations (including auxiliary washing preparations) and cleaning preparations, whether or not containing soap, other than those of heading 34.01. (HS code(s): 3402)
Regulation Type: Corrigendum to Regular Notification
DUS 970-2 :2022, Agglomerated stone - Slabs and cut-to-size products for vanity and kitchen tops, Second edition

Distribution date: 22 June 2022 | Final date for Comment: 21 August 2022
This document specifies requirements and appropriate test methods for slabs and cut-to-size products of agglomerated stone which are made for use as vanity and kitchen tops, or other similar use in furnishing (e.g. splash zone).NOTE: “Agglomerated stones” are commercially termed “engineered-stones”.This document does not cover secondary operations including site installation.
Products Covered: Agglomerated stone
Regulation Type: Regular notification
DUS 970-2 :2022, Agglomerated stone - Slabs and cut-to-size products for vanity and kitchen tops, Second edition

Distribution date: 22 June 2022 | Final date for Comment: 21 August 2022
This document specifies requirements and appropriate test methods for slabs and cut-to-size products of agglomerated stone which are made for use as vanity and kitchen tops, or other similar use in furnishing (e.g. splash zone).NOTE: “Agglomerated stones” are commercially termed “engineered-stones”.This document does not cover secondary operations including site installation.
Products Covered: Agglomerated stone
Regulation Type: Regular notification
SI 240 - Toilet soap

Distribution date: 22 June 2022 | Final date for Comment: 21 August 2022
The requirements of the existing Mandatory Standard, SI 240, dealing with toilet soap, shall be declared voluntary. This declaration aims to remove unnecessary obstacles to trade and lower trade barriers.
Products Covered: Toilet soap (HS code(s): 34011); (ICS code(s): 71.100.70)
Regulation Type: Regular notification
SI 240 - Toilet soap

Distribution date: 22 June 2022 | Final date for Comment: 21 August 2022
The requirements of the existing Mandatory Standard, SI 240, dealing with toilet soap, shall be declared voluntary. This declaration aims to remove unnecessary obstacles to trade and lower trade barriers.
Products Covered: Toilet soap (HS code(s): 34011); (ICS code(s): 71.100.70)
Regulation Type: Regular notification
DUS 1511:2022, Oxygen for medical use — Specification, Second edition

Distribution date: 22 June 2022 | Final date for Comment: 21 August 2022
This Draft Uganda Standard specifies the requirements, methods of sampling and testing of oxygen for medical use only.
Products Covered: - Oxygen (HS code(s): 280440); Medical sciences and health care facilities in general (ICS code(s): 11.020)
Regulation Type: Regular notification
DUS 1511:2022, Oxygen for medical use — Specification, Second edition

Distribution date: 22 June 2022 | Final date for Comment: 21 August 2022
This Draft Uganda Standard specifies the requirements, methods of sampling and testing of oxygen for medical use only.
Products Covered: - Oxygen (HS code(s): 280440); Medical sciences and health care facilities in general (ICS code(s): 11.020)
Regulation Type: Regular notification
Draft amendments to the Rules for conducting clinical and clinical laboratory tests of medical devices

Distribution date: 23 June 2022 | Final date for Comment: 18 September 2022
The draft amendments to the Rules for conducting clinical and clinical laboratory tests (studies) of medical devices apply to medical products put into circulation on the territory of the Eurasian Economic Union and envisage the following:clarification of the concepts;clarification of the conditions for obtaining clinical data for software that is a medical device;clarification of the conditions of comparability of medical devices when considering clinical data;clarification of the procedure for obtaining a permit for testing;clarification of test requirements;clarification of the grounds for excluding medical organizations from the unified register of authorized organizations authorized to conduct research (testing) of medical devices for the purpose of their registration;definition of requirements for the technical file of the software that is a medical device; clarification of the form of test reports.
Products Covered: Wadding, gauze, bandages and similar products (bandages, adhesive plasters, poultices) impregnated or coated with pharmaceutical substances or packaged in molds or packages for retail sale for medical, surgical, dental or veterinary purposes (HS 3005); Devices and devices used in medicine, surgery, dentistry or veterinary medicine, including scintigraphic devices, other electromedical devices and vision testing devices (HS 9018); X-ray, alpha-, beta-, gamma-emitting devices; intended or not intended for medical, surgical, dental or veterinary use, including radiographic or radiotherapy equipment, X-ray tubes and other X-ray generators, high voltage generators, shields and control panels, screens, tables, chairs and similar products for examination and treatment (HS 9022); Medical, surgical, dental or veterinary furniture (for example, operating tables, examination tables, hospital beds with mechanical devices, dental chairs) hairdressing chairs and similar chairs with devices for rotation and simultaneously for tilting and lifting; parts of the above-mentioned products (HS 9402).
Regulation Type: Regular notification
Draft amendments to the Rules for conducting clinical and clinical laboratory tests of medical devices

Distribution date: 23 June 2022 | Final date for Comment: 18 September 2022
The draft amendments to the Rules for conducting clinical and clinical laboratory tests (studies) of medical devices apply to medical products put into circulation on the territory of the Eurasian Economic Union and envisage the following:clarification of the concepts;clarification of the conditions for obtaining clinical data for software that is a medical device;clarification of the conditions of comparability of medical devices when considering clinical data;clarification of the procedure for obtaining a permit for testing;clarification of test requirements;clarification of the grounds for excluding medical organizations from the unified register of authorized organizations authorized to conduct research (testing) of medical devices for the purpose of their registration;definition of requirements for the technical file of the software that is a medical device; clarification of the form of test reports.
Products Covered: Wadding, gauze, bandages and similar products (bandages, adhesive plasters, poultices) impregnated or coated with pharmaceutical substances or packaged in molds or packages for retail sale for medical, surgical, dental or veterinary purposes (HS 3005); Devices and devices used in medicine, surgery, dentistry or veterinary medicine, including scintigraphic devices, other electromedical devices and vision testing devices (HS 9018); X-ray, alpha-, beta-, gamma-emitting devices; intended or not intended for medical, surgical, dental or veterinary use, including radiographic or radiotherapy equipment, X-ray tubes and other X-ray generators, high voltage generators, shields and control panels, screens, tables, chairs and similar products for examination and treatment (HS 9022); Medical, surgical, dental or veterinary furniture (for example, operating tables, examination tables, hospital beds with mechanical devices, dental chairs) hairdressing chairs and similar chairs with devices for rotation and simultaneously for tilting and lifting; parts of the above-mentioned products (HS 9402).
Regulation Type: Regular notification
Resolución 634 del 17 de junio de 2022 "Por la cual en desarrollo del Protocolo de Montreal, se entiende prohibida la fabricación e importación de equipos y productos que contengan y/o requieran para su operación o funcionamiento las sustancias controladas en los Anexos A, B, C, E y F del Protocolo de Montreal y se adoptan otras disposiciones" (Resolution No. 634 of 17 June 2022 "prohibiting, in accordance with the Montreal Protocol, the manufacture and importation of equipment and products that contain the controlled substances listed in Annexes A, B, C, E and F of the Montreal Protocol and/or that require those substances in order to be operational or to function, and adopting other provisions") (20 pages, in Spanish)

Distribution date: 27 June 2022 | Final date for Comment: 04 May 2025
The notified Resolution establishes provisions applicable to all natural and legal persons that manufacture and/or import certain equipment and products, where these contain, have required for their production and/or require in order to be operational or to function, the controlled substances listed in Annexes A, B, C, E and F of the Montreal Protocol.
Products Covered: In accordance with the Montreal Protocol, the manufacture and importation of equipment and products containing the controlled substances listed in Annexes A, B, C, E and F of the Protocol and/or requiring those substances in order to be operational or to function, shall be prohibited in Colombia.
Regulation Type: Regular notification
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