Regulatory Updates

Distribution date: 11 July 2022 | Final date for Comment: 04 October 2022

The Draft amendments to the Rules of classification of medical devices depending on the potential risk of use apply to medical devices and provide for the following:clarification of the concepts; clarification of classification criteria for medical devices for in vitro diagnostics; establishment of criteria and conditions for the classification of software that is a medical device; clarification of classification of medical devices.

Products Covered: Wadding, gauze, bandages and similar articles (for example, dressings, adhesive plasters, poultices), impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes. (HS code(s): 3005); Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments. (HS code(s): 9018); Apparatus based on the use of X-rays or of alpha, beta or gamma radiations, whether or not for medical, surgical, dental or veterinary uses, including radiography or radiotherapy apparatus, X-ray tubes and other X-ray generators, high tension generators, control panels and desks, screens, examination or treatment tables, chairs and the like. (HS code(s): 9022); Medical, surgical, dental or veterinary furniture (for example, operating tables, examination tables, hospital beds with mechanical fittings, dentists' chairs); barbers' chairs and similar chairs, having rotating as well as both reclining and elevating movements; parts of the foregoing articles. (HS code(s): 9402)

Regulation Type: Regular notification

Distribution date: 06 July 2022

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Products Covered: Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excl. yeasts) and similar products (HS code(s): 3002); HEALTH CARE TECHNOLOGY (ICS code(s): 11)

Regulation Type: Addendum to Regular Notification

Distribution date: 06 July 2022

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Products Covered: Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excl. yeasts) and similar products (HS code(s): 3002); HEALTH CARE TECHNOLOGY (ICS code(s): 11)

Regulation Type: Addendum to Regular Notification

Distribution date: 01 July 2022

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Products Covered: Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excl. yeasts) and similar products (HS code(s): 3002); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Addendum to Regular Notification

Distribution date: 01 July 2022

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Products Covered: Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excl. yeasts) and similar products (HS code(s): 3002); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Addendum to Regular Notification

Distribution date: 01 July 2022 | Final date for Comment: 30 August 2022

This Draft Uganda covers the determination of the chemical composition of natural gases and similar gaseous mixtures . This test method may be abbreviated for the analysis of lean natural gases containing negligible amounts of hexanes and higher hydrocarbons, or for the determination of one or more components, as required.

Products Covered: Petroleum gases and other gaseous hydrocarbons. (HS code(s): 2711); Fuels (ICS code(s): 75.160)

Regulation Type: Regular notification

Distribution date: 01 July 2022 | Final date for Comment: 30 August 2022

This Draft Uganda covers the determination of the chemical composition of natural gases and similar gaseous mixtures . This test method may be abbreviated for the analysis of lean natural gases containing negligible amounts of hexanes and higher hydrocarbons, or for the determination of one or more components, as required.

Products Covered: Petroleum gases and other gaseous hydrocarbons. (HS code(s): 2711); Fuels (ICS code(s): 75.160)

Regulation Type: Regular notification

Distribution date: 30 June 2022

To respond to the new coronavirus pandemic and to ensure the quality of medical devices for protecting the safety and well-being of the public, the Food and Drug Administration proposes to conduct inspection and examination for imported COVID-19 Antigen  Home/Self Tests.

Products Covered: COVID-19 Antigen  Home/Self Test (HS code(s): 3002)

Regulation Type: Regular notification

Distribution date: 30 June 2022

To respond to the new coronavirus pandemic and to ensure the quality of medical devices for protecting the safety and well-being of the public, the Food and Drug Administration proposes to conduct inspection and examination for imported COVID-19 Antigen  Home/Self Tests.

Products Covered: COVID-19 Antigen  Home/Self Test (HS code(s): 3002)

Regulation Type: Regular notification

Distribution date: 29 June 2022 | Final date for Comment: 28 August 2022

This Draft Uganda Standard provides requirements for food contact surfaces including packaging materials that are intended for that purpose and can be expected to come into contact with food under normal or foreseeable conditions of use." The standard does not include coverings or coatings and substances that are part of the food and may be eaten with it such as sausage skin for which other standards apply. Note: This Draft Uganda Standard was also notified to the TBT Committee.

Products Covered: Plastics and articles thereof (HS code(s): 39); Packaging materials and accessories (ICS code(s): 55.040)

Regulation Type: Revision to Regular Notification