Regulatory Updates

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

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

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

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

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

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

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

Distribution date: 21 June 2022

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

Distribution date: 21 June 2022

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

Distribution date: 21 June 2022

The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu would like to notify that the “Amendment of Article 4 of Regulations for Cosmetic Product Information File Management," as per G/TBT/N/TPKM/474 on 17 November 2021, was promulgated and came into effect on 16 June 2022.

Products Covered: ESSENTIAL OILS AND RESINOIDS; PERFUMERY, COSMETIC OR TOILET PREPARATIONS (HS code(s): 33)

Regulation Type: Addendum to Regular Notification