Regulatory Updates
SI 14079 Part 3 - Non-active medical devices - Performance requirements and test methods: Gauze pad
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
SI 1147 Part 2 - Elastic bandage: 1:4 bandage made of elastomeric and cotton or rayon yarns
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
SI 1147 - Elastic bandage: General requirements
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
SI 597 Part 1 - Cotton wool: Medical cotton wool
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
SI 14079 Part 2 - Non-active medical devices - Performance requirements and test methods: Gauze bandage
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
SI 14079 Part 1 - Non-active medical devices - Performance requirements and test methods: Absorbent cotton gauze and absorbent cotton and viscose gauze
Distribution date: 11 March 2025 | Final date for Comment: 10 May 2025
The existing Mandatory Standard, SI 14079 part 1, dealing with absorbent gauzes, 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 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: Non-active medical devices - Absorbent gauzes (HS code(s): 300590); (ICS code(s): 11.120.20)
Regulation Type: Regular notification
SI 1147 Part 1 - Elastic bandage: 1:3 bandage made of elastomeric and cotton or elastomeric and cotton-polyester or elastomeric and rayon yarns
Distribution date: 11 March 2025 | Final date for Comment: 10 May 2025
The existing Mandatory Standard, SI 1147 part 1, dealing with 1:3 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
SI 1228 - Zinc oxid elastic adhesive bandage
Distribution date: 11 March 2025 | Final date for Comment: 10 May 2025
The existing Mandatory Standard, SI 1228, dealing with zinc oxide elastic adhesive 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.
Products Covered: Zinc oxid elastic adhesive bandage (HS code(s): 300510); (ICS code(s): 11.120.20)
Regulation Type: Regular notification
SI 1147 Part 3 - Elastic bandage: Bandage made of warp covered elastomeric yarns and weft cotton or rayon yarn
Distribution date: 11 March 2025 | Final date for Comment: 10 May 2025
The existing Mandatory Standard, SI 1147 part 3, dealing with elastic 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
Commission Implementing Regulation (EU) 2025/182 of 31 January 2025 correcting Implementing Regulation (EU) 2019/901 to correct the chemical formula of riboflavin 5′- phosphate monosodium salt (Text with EEA relevance)
Distribution date: 11 March 2025
The substance of riboflavin 5′- phosphate monosodium salt was authorised as feed additive for all animal species other than aquatic by Commission Implementing Regulation (EU) 2019/901 for a 10-year period. The current Implementing Regulation (EU) 2025/182 is correcting the chemical formula in the characterisation of the active substance laid down in Implementing Regulation (EU) 2019/901, which was not correct.
Products Covered: Preparations of a kind used in animal feeding (HS code(s): 2309)
Regulation Type: Regular notification
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