Distribution date: 11 March 2025 | Final date for Comment: 10 May 2025

The existing Mandatory Standard, SI 14079 part 2, dealing with gauze bandages, shall be declared voluntary. This declaration aims to remove unnecessary trade obstacles and lower trade barriers.These gauzes are listed in the Israel Medical Devices Law 5772-2012, which requires pre-registering in a Recognized Country and presenting a CE or FDA certification proving compliance with European and/or US Regulations for medical devices or other recognized regulatory bodies. The registration process in the Medical Devices Register is sufficient, and there is no need for duplication or regulatory overlap.

Products Covered: Non-active medical devices - Gauze bandages (HS code(s): 300590); (ICS code(s): 11.120.20)

Regulation Type: Regular notification

Distribution date: 11 March 2025 | Final date for Comment: 10 May 2025

The existing Mandatory Standard, SI 597 part 1, dealing with medical cotton wool, shall be declared voluntary. This declaration aims to remove unnecessary trade obstacles and lower trade barriers.These medical cotton wools are listed in the Israel Medical Devices Law 5772-2012, which requires pre-registering in a Recognized Country and presenting a CE or FDA certification proving compliance with European and/or US medical devices regulations or other recognized regulatory bodies. The registration process in the Medical Devices Register is sufficient, and there is no need for regulatory duplication or overlap.

Products Covered: Medical cotton wool (HS code(s): 300590; 560121); (ICS code(s): 11.040.30; 11.120.20; 59.080.99)

Regulation Type: Regular notification

Distribution date: 11 March 2025 | Final date for Comment: 10 May 2025

The existing Mandatory Standard, SI 1147, dealing with the general requirements for elastic bandages, shall be declared voluntary. This declaration aims to remove unnecessary trade obstacles and lower trade barriers.These bandages are listed in the Israel Medical Devices Law 5772-2012, which requires pre-registering in a Recognized Country and presenting a CE or FDA certification proving compliance with European and/or US medical devices regulations or other recognized regulatory bodies. The registration process in the Medical Devices Register is sufficient, and there is no need for regulatory duplication or overlap.This standard is also being revised, as notified in G/TBT/N/ISR/1359. Should the revision process be completed before this declaration, it will apply to the newly revised standard, SI 1147. 

Products Covered: Elastic bandages (HS code(s): 300590); (ICS code(s): 11.120.20)

Regulation Type: Regular notification

Distribution date: 11 March 2025 | Final date for Comment: 10 May 2025

The existing Mandatory Standard, SI 1147 part 2, dealing with 1:4 bandages, shall be declared voluntary. This declaration aims to remove unnecessary trade obstacles and lower trade barriers. These types of bandages are listed in the Israel Medical Devices Law 5772-2012, which requires pre-registering in a Recognized Country and presenting a CE or FDA certification proving compliance with European and/or US medical devices regulations or other recognized regulatory bodies. The registration process in the Medical Devices Register is sufficient, and there is no need for regulatory duplication or overlap.This standard is also being revised, as notified in G/TBT/N/ISR/1359. Should the revision process be completed before this declaration, it will apply to the newly revised standard, SI 1147. 

Products Covered: Elastic bandages (HS code(s): 300590); (ICS code(s): 11.120.20)

Regulation Type: Regular notification

Distribution date: 11 March 2025 | Final date for Comment: 10 May 2025

The existing Mandatory Standard, SI 14079 part 3, dealing with gauze pads, shall be declared voluntary. This declaration aims to remove unnecessary trade obstacles and lower trade barriers.These gauze pads are listed in the Israel Medical Devices Law 5772-2012, which requires pre-registering in a Recognized Country and presenting a CE or FDA certification proving compliance with European and/or US Regulations for medical devices or other recognized regulatory bodies. The registration process in the Medical Devices Register is sufficient, and there is no need for duplication or regulatory overlap.

Products Covered: Non-active medical devices - Gauze pads (HS code(s): 300590); (ICS code(s): 11.120.20)

Regulation Type: Regular notification

Distribution date: 11 March 2025 | Final date for Comment: 10 May 2025

The existing Mandatory Standard, SI 1084, dealing with plaster for medical use, will be declared voluntary. This declaration aims to remove unnecessary trade obstacles and lower trade barriers.These plasters are listed in the Israel Medical Devices Law 5772-2012, which requires pre-registering in a Recognized Country and presenting a CE or FDA certification proving compliance with European and/or US medical devices regulations or other recognized regulatory bodies. The registration process in the Medical Devices Register is sufficient, and there is no need for regulatory duplication or overlap.

Products Covered: Plaster for medical use (HS code(s): 300510); (ICS code(s): 11.120.20)

Regulation Type: Regular notification

Distribution date: 11 March 2025 | Final date for Comment: 19 April 2025

The notified Decree aims to incorporate into national legislation MERCOSUR Common Market Group (GMC) Resolution No. 48/21, "MERCOSUR Technical Regulation on the labels for personal hygiene products, cosmetics and perfumes (Repeal of GMC Resolutions Nos. 36/99 and 36/04)".

Products Covered: Cosmetics. Toiletries (ICS code: 71.100.70)

Regulation Type: Regular notification

Distribution date: 12 March 2025 | Final date for Comment: 11 May 2025

This document specifies the product classification, technical requirements, testing methods, marking and instructions, maintenance, personnel training, and safety precautions for emergency shower and eyewash equipment.This document applies to the design, manufacturing, testing, installation, and maintenance of emergency shower and eyewash equipment for personnel who are  exposed to splashed of hazardous chemicals or other dangerous substances in the workplace and need to perform emergency flushing treatment.

Products Covered: Emergency shower, eyewash, eye/face wash, combination units (HS code(s): 848180); (ICS code(s): 13.340.99)

Regulation Type: Regular notification

Distribution date: 12 March 2025 | Final date for Comment: 11 May 2025

This document specifies the classification and style requirements for harmlessness, ergonomic requirements, general requirements for foot protection footwear, protective performance requirements, permanent marking, and information to be provided by the manufacturer of foot protection equipment.This document applies to foot protection equipment designed to protect the wearer's feet from hazards in the workplace or ensure the safety of the work environment.

Products Covered: safety shoes and chemical resistant shoes(HS code(s): 640340); (ICS code(s): 13.340.50)

Regulation Type: Regular notification

Distribution date: 12 March 2025 | Final date for Comment: 11 May 2025

This document specifies the classification, grading, marking, technical requirements, test methods, marking, and packaging of self-contained closed-circuit oxygen breathing apparatus for escape.This document applies to breathing apparatus used for escape in workplaces and public places ,including escape from hazardous chemical accidents.

Products Covered: Self-contained closed-circuit oxygen breathing apparatus for escape (HS code(s): 9020); (ICS code(s): 13.340.30)

Regulation Type: Regular notification