Regulatory Updates

Draft amendments to the Rules for registration and examination of safety, quality and effectiveness of medical devices 

Product Image

Distribution date: 18 May 2026 | Final date for Comment: 14 June 2026

The draft amendments to the Rules for registration and examination of safety, quality and effectiveness of medical devices provides for the possibility of suspending the validity of the marketing authorization in the event that there is no valid report on the results of inspection in the marketing authorization application of a medical device in order to prevent the release into circulation of a poor quality medical product. 

Products Covered: Cotton wool, gauze, bandages and similar articles (for example, bandages, Band-Aids, poultices), impregnated or coated with pharmaceutical substances or packaged in forms or packages for retail sale, intended for use in medicine, surgery, dentistry or veterinary medicine (HS 3005); Devices and instruments used in medicine, surgery, dentistry or veterinary medicine, including scintigraphic equipment, other electro-medical equipment and vision testers (HS 9018); Equipment based on the use of X-ray, alpha, beta or gamma radiation, intended or not intended for medical, surgical, dental or veterinary use, including X-ray 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 or treatment (HS 9022); Medical, surgical, dental or veterinary furniture (for example, operating tables, examination tables, hospital beds with mechanical devices, dental chairs); barber chairs and similar chairs with devices for rotating and simultaneously for tilting and lifting; parts of the above-mentioned products (HS Code 9402).

Regulation Type: Regular notification

Human health

Proyecto de Decreto “Por el cual se establece el régimen sanitario aplicable a los dispositivos médicos, se definen las reglas para su autorización de comercialización, vigilancia y control sanitario, y se dictan otras disposiciones”

Product Image

Distribution date: 18 May 2026 | Final date for Comment: 17 July 2026

El proyecto de decreto establece el nuevo régimen sanitario aplicable a los dispositivos médicos para uso humano y a los dispositivos médicos de diagnóstico in vitro en Colombia, incluyendo disposiciones relacionadas con fabricación, importación, comercialización, acondicionamiento, almacenamiento, etiquetado, vigilancia sanitaria y evaluación de la conformidad. La medida incorpora un esquema regulatorio basado en el nivel de riesgo de los dispositivos médicos y define requisitos aplicables al otorgamiento, modificación, renovación y cancelación de las autorizaciones sanitarias correspondientes. Asimismo, establece disposiciones sobre Buenas Prácticas de Manufactura (BPM), Certificados de Capacidad de Almacenamiento y Acondicionamiento (CCAA), vigilancia poscomercialización, trazabilidad y obligaciones de fabricantes, importadores y demás actores de la cadena de suministro. El proyecto tiene como finalidad garantizar la calidad, seguridad y desempeño de los dispositivos médicos con el objetivo de minimizar los riesgos para la salud y seguridad humana, así como proteger a las personas que los utilicen.

Products Covered: Dispositivos médicos para uso humano, incluidos los reactivos de diagnóstico In Vitro (DMDIV), dispositivos médicos adaptados al paciente y dispositivos médicos adaptables. Los componentes, partes, accesorios y programas informáticos, cuando formen parte de un dispositivo médico, se utilicen juntamente con este o estén específicamente destinados a su uso. (Código(s) del SA: 3005; 3006; 38221; 401512; 9018; 9019; 9020; 9021; 9022)

Regulation Type: Regular notification

Human health

DARS 2179:2026, Road marking paints — Specification, First Edition

Product Image

Distribution date: 13 May 2026 | Final date for Comment: 12 July 2026

This Draft African Standard specifies requirements, sampling and test methods for solvent-borne and waterborne paints for marking on bituminous or concrete surfaces. It makes provision for white, yellow, and black colours.

Products Covered: Paints and varnishes based, incl. enamels and lacquers, on synthetic polymers or chemically modified natural polymers, dispersed or dissolved in a non-aqueous medium, and solutions of products of headings 3901 to 3913 in volatile organic solvents, containing > 50% solvent by weight (excl. those based on polyesters and acrylic or vinyl polymers and solutions of collodion) (HS code(s): 320890); Paints and varnishes (ICS code(s): 87.040); Road marking paints

Regulation Type: Regular notification

DARS 2178:2026, Gloss solvent borne paint for interior and exterior use — Specification, First Edition

Product Image

Distribution date: 13 May 2026 | Final date for Comment: 12 July 2026

This Draft African Standard specifies requirements, sampling and test methods for gloss solvent-borne paint for interior and exterior use. This standard does not apply to paint for automotive, road marking and industrial applications.

Products Covered: Paints and varnishes, incl. enamels and lacquers, based on polyesters, dispersed or dissolved in a non-aqueous medium; solutions based on polyesters in volatile organic solvents, containing > 50% solvent by weight (HS code(s): 320810); Paints and varnishes (ICS code(s): 87.040); Gloss solvent borne paint

Regulation Type: Regular notification

Technical Regulation for the Labelling of Pre-Packaged Goods

Product Image

Distribution date: 13 May 2026 | Final date for Comment: 11 July 2026

The Technical Regulation lays down rules governing the labelling of pre-packaged goods, their importation, production and trade within Jamaica. The proposed technical regulation aims to provide a scope, application, terms and definitions, general, specific product labelling requirements and administrative provisions.

Products Covered: Footwear HS Code: 6401-6406, Industrial Gloves HS Code: 6216, 4015, Textile Products HS Code: 6115, Pantyhose HS Code: 6115, Pesticides HS Code: 3808 Aerosol Insecticides HS Code: 3808, Household Chemicals HS Code: 3402, Hazardous Industrial Chemicals HS Code: 3824, Ozone depleting substances HS Code: 2903, Adhesives HS Code: 3506, Finishes HS Code: 3210, 3208,  Staple and Nails HS Code: 7317, Household Electrical Appliances HS Code: 8509, Energy Labelling of Appliances HS Code: 8418, 8539, 8509, Refrigerating Appliances HS Code: 8418, Animal Feed HS Code: 2309, Seed Packages HS Code: 1209, Gold HS Code: 7108, Platinum HS Code: 7110, Silver  HS Code: 7106, Toys HS Code: 9503, Furniture HS Code: 9403, Paper and Paper products HS Code: 48

Regulation Type: Regular notification

Labelling

DEAS 1347:2026, Whiteboard — Specification, First Edition

Product Image

Distribution date: 13 May 2026 | Final date for Comment: 12 July 2026

This Draft East African Standard specifies requirements, and test methods, for whiteboards intended for use in educational, office, industrial, and domestic environments. It applies to wall‑mounted, mobile, and interactive whiteboards, including those with magnetic surfaces, grid lines, or specialized coatings.

Products Covered: Slates and boards, with writing or drawing surfaces, whether or not framed. (HS code(s): 9610); Office machines (ICS code(s): 35.260); Whiteboard

Regulation Type: Regular notification

DEAS 1347:2026, Whiteboard — Specification, First Edition

Product Image

Distribution date: 13 May 2026 | Final date for Comment: 12 July 2026

This Draft East African Standard specifies requirements, and test methods, for whiteboards intended for use in educational, office, industrial, and domestic environments. It applies to wall‑mounted, mobile, and interactive whiteboards, including those with magnetic surfaces, grid lines, or specialized coatings.

Products Covered: Slates and boards, with writing or drawing surfaces, whether or not framed. (HS code(s): 9610); Office machines (ICS code(s): 35.260); Whiteboard

Regulation Type: Regular notification

DEAS 1347:2026, Whiteboard — Specification, First Edition

Product Image

Distribution date: 13 May 2026 | Final date for Comment: 12 July 2026

This Draft East African Standard specifies requirements, and test methods, for whiteboards intended for use in educational, office, industrial, and domestic environments. It applies to wall‑mounted, mobile, and interactive whiteboards, including those with magnetic surfaces, grid lines, or specialized coatings.

Products Covered: Slates and boards, with writing or drawing surfaces, whether or not framed. (HS code(s): 9610); Office machines (ICS code(s): 35.260); Whiteboard

Regulation Type: Regular notification

DEAS 1347:2026, Whiteboard — Specification, First Edition

Product Image

Distribution date: 13 May 2026 | Final date for Comment: 12 July 2026

This Draft East African Standard specifies requirements, and test methods, for whiteboards intended for use in educational, office, industrial, and domestic environments. It applies to wall‑mounted, mobile, and interactive whiteboards, including those with magnetic surfaces, grid lines, or specialized coatings.

Products Covered: Slates and boards, with writing or drawing surfaces, whether or not framed. (HS code(s): 9610); Office machines (ICS code(s): 35.260); Whiteboard

Regulation Type: Regular notification

DEAS 1347:2026, Whiteboard — Specification, First Edition

Product Image

Distribution date: 13 May 2026 | Final date for Comment: 12 July 2026

This Draft East African Standard specifies requirements, and test methods, for whiteboards intended for use in educational, office, industrial, and domestic environments. It applies to wall‑mounted, mobile, and interactive whiteboards, including those with magnetic surfaces, grid lines, or specialized coatings.

Products Covered: Slates and boards, with writing or drawing surfaces, whether or not framed. (HS code(s): 9610); Office machines (ICS code(s): 35.260); Whiteboard

Regulation Type: Regular notification

Submit your email ID to receive notifications about upcoming courses and events