Israel medical device regulations

Annex A treats manufacturer changes including manufacturer name/address without a manufacturing-site change as administrative, and lists manufacturer declaration, a manufacturer explanation that the same company only changed its name, declaration of conformity, ISO 13485 and labels where required. Use this evidence route for an actual same-company rename or office-address change; do not represent a new legal manufacturer as the same company merely because its factory is unchanged.

For the separately registered Class I/low-risk IVD group identified by the procedure, the Annex A table permits the listed device-name, model-addition, manufacturer name/address, manufacturing-site detail and holder-detail changes by self-declaration in the registration system, with an updated certificate issued through that declaration route. Actual transfer of registration ownership is expressly excluded from the holder-detail row.

Obtain approval before implementation in Israel for material changes, for non-material/administrative changes affecting registration-certificate particulars, and for safety-action changes even if certificate particulars are unaffected. A non-material/administrative change that neither affects certificate particulars nor results from a safety action may be implemented immediately with the change application deferred to renewal. A new intended purpose, certain risk-class increases or addition of a product outside the registered model/accessory/system boundary requires new registration before marketing.

A change file includes the completed application PDF, a short explanation of the nature and reason for the change, and the Annex A supporting documents where information differs from the original file. Include manufacturer explanation for an adverse event/FSCA and the appropriate holder declaration: regular-route declaration or fast-route lawyer-affirmed affidavit. Complete all registered device/model and regulatory-certificate details, not only the changed REF or newly added model.

ILS 0

Per application

The Ministry page instructs applicants to enter ILS 0 in the payment field.

Registration Regulations 6(b) expressly applies Regulation 5(a)–(c) to registration-change decisions: decision within 120 days of filing, with the period awaiting requested additional data added to that period; after approval, registration certificate within three working days of the decision. This is a change-specific statutory framework, not a promise that every combined transfer or fast-track case takes 120 days.

For eligible fast changes, REG-2024/06 lists administrative and non-material changes at up to 10 working days. Material changes are up to 45 working days in fast 1 (FDA Class II, EU IIa or corresponding IVD self-test/B categories), or up to 60 working days in fast 2 (EU IIb or corresponding IVD List B/C with the required independent approvals). The Class III table has no material-change fast option. Select the actual reference approval, class and change channel; do not substitute a new-registration clock.

Registration Regulation23 requires the trade name, manufacturer and country of manufacture, holder name/address/public contact and the other prescribed identity/safety particulars on packaging or the enclosed leaflet as directed. The general three-language rule is Hebrew, Arabic and English; a non-home-use exemption from some or all language particulars requires the director’s grant on request. A brand, name or holder change must keep the approved label identity consistent.

Under Registration Regulation18 the director may, on the registration holder’s request, issue a certificate that a specified device is registered and permitted to be marketed in Israel. This supports a CFS for the current registration/holder particulars; it does not prescribe automatic reissuance, a change-specific CFS fee, a processing clock or permission for the successor to use an outdated certificate.

Annex A treats manufacturer changes including manufacturer name/address without a manufacturing-site change as administrative, and lists manufacturer declaration, a manufacturer explanation that the same company only changed its name, declaration of conformity, ISO 13485 and labels where required. Use this evidence route for an actual same-company rename or office-address change; do not represent a new legal manufacturer as the same company merely because its factory is unchanged.

For the separately registered Class I/low-risk IVD group identified by the procedure, the Annex A table permits the listed device-name, model-addition, manufacturer name/address, manufacturing-site detail and holder-detail changes by self-declaration in the registration system, with an updated certificate issued through that declaration route. Actual transfer of registration ownership is expressly excluded from the holder-detail row.

Obtain approval before implementation in Israel for material changes, for non-material/administrative changes affecting registration-certificate particulars, and for safety-action changes even if certificate particulars are unaffected. A non-material/administrative change that neither affects certificate particulars nor results from a safety action may be implemented immediately with the change application deferred to renewal. A new intended purpose, certain risk-class increases or addition of a product outside the registered model/accessory/system boundary requires new registration before marketing.

A change file includes the completed application PDF, a short explanation of the nature and reason for the change, and the Annex A supporting documents where information differs from the original file. Include manufacturer explanation for an adverse event/FSCA and the appropriate holder declaration: regular-route declaration or fast-route lawyer-affirmed affidavit. Complete all registered device/model and regulatory-certificate details, not only the changed REF or newly added model.

ILS 0

Per application

The Ministry page instructs applicants to enter ILS 0 in the payment field.

Registration Regulations 6(b) expressly applies Regulation 5(a)–(c) to registration-change decisions: decision within 120 days of filing, with the period awaiting requested additional data added to that period; after approval, registration certificate within three working days of the decision. This is a change-specific statutory framework, not a promise that every combined transfer or fast-track case takes 120 days.

For eligible fast changes, REG-2024/06 lists administrative and non-material changes at up to 10 working days. Material changes are up to 45 working days in fast 1 (FDA Class II, EU IIa or corresponding IVD self-test/B categories), or up to 60 working days in fast 2 (EU IIb or corresponding IVD List B/C with the required independent approvals). The Class III table has no material-change fast option. Select the actual reference approval, class and change channel; do not substitute a new-registration clock.

Registration Regulation23 requires the trade name, manufacturer and country of manufacture, holder name/address/public contact and the other prescribed identity/safety particulars on packaging or the enclosed leaflet as directed. The general three-language rule is Hebrew, Arabic and English; a non-home-use exemption from some or all language particulars requires the director’s grant on request. A brand, name or holder change must keep the approved label identity consistent.

Under Registration Regulation18 the director may, on the registration holder’s request, issue a certificate that a specified device is registered and permitted to be marketed in Israel. This supports a CFS for the current registration/holder particulars; it does not prescribe automatic reissuance, a change-specific CFS fee, a processing clock or permission for the successor to use an outdated certificate.

One registration-change request may include multiple changes if each is clearly described in the cover letter. An open change request must finish before another change or renewal request. These rules support cumulative brand/name/address/actual-REF assessment, but a transfer of registration holder follows separate ownership instructions. A genuine new legal manufacturer must be assessed against current manufacturer/conformity evidence rather than assumed to satisfy the same-company administrative row.

Changes to a registered device are classified by the manufacturer as 'material' (מהותי), 'non-material' (לא מהותי) or 'administrative' (אדמיניסטרטיבי); it is the registration holder's responsibility to verify the nature and classification of each change with the manufacturer and file the change application accordingly. Combination rules: several material changes, or material combined with non-material/administrative, are filed as one 'material' application; non-material combined with administrative is filed as 'non-material' (one row for the highest-ranked change). An EU-reclassification increase in risk class requires a 'material' change application. Categories marked '^V' in the change procedure may be filed through the fast 'non-material' channel despite being manufacturer-classified material.

When filing a renewal application (regular or fast track), only 'non-material' and/or 'administrative' change requests may be bundled in addition, with the appropriate declaration wording attached.

Annex A treats manufacturer changes including manufacturer name/address without a manufacturing-site change as administrative, and lists manufacturer declaration, a manufacturer explanation that the same company only changed its name, declaration of conformity, ISO 13485 and labels where required. Use this evidence route for an actual same-company rename or office-address change; do not represent a new legal manufacturer as the same company merely because its factory is unchanged.

For the separately registered Class I/low-risk IVD group identified by the procedure, the Annex A table permits the listed device-name, model-addition, manufacturer name/address, manufacturing-site detail and holder-detail changes by self-declaration in the registration system, with an updated certificate issued through that declaration route. Actual transfer of registration ownership is expressly excluded from the holder-detail row.

Obtain approval before implementation in Israel for material changes, for non-material/administrative changes affecting registration-certificate particulars, and for safety-action changes even if certificate particulars are unaffected. A non-material/administrative change that neither affects certificate particulars nor results from a safety action may be implemented immediately with the change application deferred to renewal. A new intended purpose, certain risk-class increases or addition of a product outside the registered model/accessory/system boundary requires new registration before marketing.

A change file includes the completed application PDF, a short explanation of the nature and reason for the change, and the Annex A supporting documents where information differs from the original file. Include manufacturer explanation for an adverse event/FSCA and the appropriate holder declaration: regular-route declaration or fast-route lawyer-affirmed affidavit. Complete all registered device/model and regulatory-certificate details, not only the changed REF or newly added model.

ILS 0

Per application

The Ministry page instructs applicants to enter ILS 0 in the payment field.

Registration Regulations 6(b) expressly applies Regulation 5(a)–(c) to registration-change decisions: decision within 120 days of filing, with the period awaiting requested additional data added to that period; after approval, registration certificate within three working days of the decision. This is a change-specific statutory framework, not a promise that every combined transfer or fast-track case takes 120 days.

For eligible fast changes, REG-2024/06 lists administrative and non-material changes at up to 10 working days. Material changes are up to 45 working days in fast 1 (FDA Class II, EU IIa or corresponding IVD self-test/B categories), or up to 60 working days in fast 2 (EU IIb or corresponding IVD List B/C with the required independent approvals). The Class III table has no material-change fast option. Select the actual reference approval, class and change channel; do not substitute a new-registration clock.

Registration Regulation23 requires the trade name, manufacturer and country of manufacture, holder name/address/public contact and the other prescribed identity/safety particulars on packaging or the enclosed leaflet as directed. The general three-language rule is Hebrew, Arabic and English; a non-home-use exemption from some or all language particulars requires the director’s grant on request. A brand, name or holder change must keep the approved label identity consistent.

Under Registration Regulation18 the director may, on the registration holder’s request, issue a certificate that a specified device is registered and permitted to be marketed in Israel. This supports a CFS for the current registration/holder particulars; it does not prescribe automatic reissuance, a change-specific CFS fee, a processing clock or permission for the successor to use an outdated certificate.

One registration-change request may include multiple changes if each is clearly described in the cover letter. An open change request must finish before another change or renewal request. These rules support cumulative brand/name/address/actual-REF assessment, but a transfer of registration holder follows separate ownership instructions. A genuine new legal manufacturer must be assessed against current manufacturer/conformity evidence rather than assumed to satisfy the same-company administrative row.

Changes to a registered device are classified by the manufacturer as 'material' (מהותי), 'non-material' (לא מהותי) or 'administrative' (אדמיניסטרטיבי); it is the registration holder's responsibility to verify the nature and classification of each change with the manufacturer and file the change application accordingly. Combination rules: several material changes, or material combined with non-material/administrative, are filed as one 'material' application; non-material combined with administrative is filed as 'non-material' (one row for the highest-ranked change). An EU-reclassification increase in risk class requires a 'material' change application. Categories marked '^V' in the change procedure may be filed through the fast 'non-material' channel despite being manufacturer-classified material.

When filing a renewal application (regular or fast track), only 'non-material' and/or 'administrative' change requests may be bundled in addition, with the appropriate declaration wording attached.

Annex A treats manufacturer changes including manufacturer name/address without a manufacturing-site change as administrative, and lists manufacturer declaration, a manufacturer explanation that the same company only changed its name, declaration of conformity, ISO 13485 and labels where required. Use this evidence route for an actual same-company rename or office-address change; do not represent a new legal manufacturer as the same company merely because its factory is unchanged.

For the separately registered Class I/low-risk IVD group identified by the procedure, the Annex A table permits the listed device-name, model-addition, manufacturer name/address, manufacturing-site detail and holder-detail changes by self-declaration in the registration system, with an updated certificate issued through that declaration route. Actual transfer of registration ownership is expressly excluded from the holder-detail row.

Obtain approval before implementation in Israel for material changes, for non-material/administrative changes affecting registration-certificate particulars, and for safety-action changes even if certificate particulars are unaffected. A non-material/administrative change that neither affects certificate particulars nor results from a safety action may be implemented immediately with the change application deferred to renewal. A new intended purpose, certain risk-class increases or addition of a product outside the registered model/accessory/system boundary requires new registration before marketing.

A change file includes the completed application PDF, a short explanation of the nature and reason for the change, and the Annex A supporting documents where information differs from the original file. Include manufacturer explanation for an adverse event/FSCA and the appropriate holder declaration: regular-route declaration or fast-route lawyer-affirmed affidavit. Complete all registered device/model and regulatory-certificate details, not only the changed REF or newly added model.

ILS 0

Per application

The Ministry page instructs applicants to enter ILS 0 in the payment field.

Registration Regulations 6(b) expressly applies Regulation 5(a)–(c) to registration-change decisions: decision within 120 days of filing, with the period awaiting requested additional data added to that period; after approval, registration certificate within three working days of the decision. This is a change-specific statutory framework, not a promise that every combined transfer or fast-track case takes 120 days.

For eligible fast changes, REG-2024/06 lists administrative and non-material changes at up to 10 working days. Material changes are up to 45 working days in fast 1 (FDA Class II, EU IIa or corresponding IVD self-test/B categories), or up to 60 working days in fast 2 (EU IIb or corresponding IVD List B/C with the required independent approvals). The Class III table has no material-change fast option. Select the actual reference approval, class and change channel; do not substitute a new-registration clock.

Registration Regulation23 requires the trade name, manufacturer and country of manufacture, holder name/address/public contact and the other prescribed identity/safety particulars on packaging or the enclosed leaflet as directed. The general three-language rule is Hebrew, Arabic and English; a non-home-use exemption from some or all language particulars requires the director’s grant on request. A brand, name or holder change must keep the approved label identity consistent.

Under Registration Regulation18 the director may, on the registration holder’s request, issue a certificate that a specified device is registered and permitted to be marketed in Israel. This supports a CFS for the current registration/holder particulars; it does not prescribe automatic reissuance, a change-specific CFS fee, a processing clock or permission for the successor to use an outdated certificate.

One registration-change request may include multiple changes if each is clearly described in the cover letter. An open change request must finish before another change or renewal request. These rules support cumulative brand/name/address/actual-REF assessment, but a transfer of registration holder follows separate ownership instructions. A genuine new legal manufacturer must be assessed against current manufacturer/conformity evidence rather than assumed to satisfy the same-company administrative row.

Changes to a registered device are classified by the manufacturer as 'material' (מהותי), 'non-material' (לא מהותי) or 'administrative' (אדמיניסטרטיבי); it is the registration holder's responsibility to verify the nature and classification of each change with the manufacturer and file the change application accordingly. Combination rules: several material changes, or material combined with non-material/administrative, are filed as one 'material' application; non-material combined with administrative is filed as 'non-material' (one row for the highest-ranked change). An EU-reclassification increase in risk class requires a 'material' change application. Categories marked '^V' in the change procedure may be filed through the fast 'non-material' channel despite being manufacturer-classified material.

When filing a renewal application (regular or fast track), only 'non-material' and/or 'administrative' change requests may be bundled in addition, with the appropriate declaration wording attached.

For the separately registered Class I/low-risk IVD group identified by the procedure, the Annex A table permits the listed device-name, model-addition, manufacturer name/address, manufacturing-site detail and holder-detail changes by self-declaration in the registration system, with an updated certificate issued through that declaration route. Actual transfer of registration ownership is expressly excluded from the holder-detail row.

Obtain approval before implementation in Israel for material changes, for non-material/administrative changes affecting registration-certificate particulars, and for safety-action changes even if certificate particulars are unaffected. A non-material/administrative change that neither affects certificate particulars nor results from a safety action may be implemented immediately with the change application deferred to renewal. A new intended purpose, certain risk-class increases or addition of a product outside the registered model/accessory/system boundary requires new registration before marketing.

A change of registration holder uses the separate ownership-transfer instructions, not the ordinary holder-name/address row. With the existing holder’s consent and at least three months remaining certificate validity, submit a transfer/change request with cover letter, updated electronic form, consent letter, updated manufacturer and importer declarations, the new holder’s ISO9001 (or ISO13485 for a local manufacturer) and business licence. Without the old holder’s consent, the new importer must submit a new registration application with the full required dossier.

On change of the registration holder/importer, the new registration holder's declaration replaces the old importer declaration; in the fast track a lawyer-signed affidavit of the appropriate wording must be filed.

One registration-change request may include multiple changes if each is clearly described in the cover letter. An open change request must finish before another change or renewal request. These rules support cumulative brand/name/address/actual-REF assessment, but a transfer of registration holder follows separate ownership instructions. A genuine new legal manufacturer must be assessed against current manufacturer/conformity evidence rather than assumed to satisfy the same-company administrative row.

A change file includes the completed application PDF, a short explanation of the nature and reason for the change, and the Annex A supporting documents where information differs from the original file. Include manufacturer explanation for an adverse event/FSCA and the appropriate holder declaration: regular-route declaration or fast-route lawyer-affirmed affidavit. Complete all registered device/model and regulatory-certificate details, not only the changed REF or newly added model.

ILS 0

Per application

The Ministry page instructs applicants to enter ILS 0 in the payment field.

Registration Regulations 6(b) expressly applies Regulation 5(a)–(c) to registration-change decisions: decision within 120 days of filing, with the period awaiting requested additional data added to that period; after approval, registration certificate within three working days of the decision. This is a change-specific statutory framework, not a promise that every combined transfer or fast-track case takes 120 days.

For eligible fast changes, REG-2024/06 lists administrative and non-material changes at up to 10 working days. Material changes are up to 45 working days in fast 1 (FDA Class II, EU IIa or corresponding IVD self-test/B categories), or up to 60 working days in fast 2 (EU IIb or corresponding IVD List B/C with the required independent approvals). The Class III table has no material-change fast option. Select the actual reference approval, class and change channel; do not substitute a new-registration clock.

Registration Regulation23 requires the trade name, manufacturer and country of manufacture, holder name/address/public contact and the other prescribed identity/safety particulars on packaging or the enclosed leaflet as directed. The general three-language rule is Hebrew, Arabic and English; a non-home-use exemption from some or all language particulars requires the director’s grant on request. A brand, name or holder change must keep the approved label identity consistent.

Under Registration Regulation18 the director may, on the registration holder’s request, issue a certificate that a specified device is registered and permitted to be marketed in Israel. This supports a CFS for the current registration/holder particulars; it does not prescribe automatic reissuance, a change-specific CFS fee, a processing clock or permission for the successor to use an outdated certificate.

Annex A treats manufacturer changes including manufacturer name/address without a manufacturing-site change as administrative, and lists manufacturer declaration, a manufacturer explanation that the same company only changed its name, declaration of conformity, ISO 13485 and labels where required. Use this evidence route for an actual same-company rename or office-address change; do not represent a new legal manufacturer as the same company merely because its factory is unchanged.

For the separately registered Class I/low-risk IVD group identified by the procedure, the Annex A table permits the listed device-name, model-addition, manufacturer name/address, manufacturing-site detail and holder-detail changes by self-declaration in the registration system, with an updated certificate issued through that declaration route. Actual transfer of registration ownership is expressly excluded from the holder-detail row.

Obtain approval before implementation in Israel for material changes, for non-material/administrative changes affecting registration-certificate particulars, and for safety-action changes even if certificate particulars are unaffected. A non-material/administrative change that neither affects certificate particulars nor results from a safety action may be implemented immediately with the change application deferred to renewal. A new intended purpose, certain risk-class increases or addition of a product outside the registered model/accessory/system boundary requires new registration before marketing.

A change of registration holder uses the separate ownership-transfer instructions, not the ordinary holder-name/address row. With the existing holder’s consent and at least three months remaining certificate validity, submit a transfer/change request with cover letter, updated electronic form, consent letter, updated manufacturer and importer declarations, the new holder’s ISO9001 (or ISO13485 for a local manufacturer) and business licence. Without the old holder’s consent, the new importer must submit a new registration application with the full required dossier.

Changes to a registered device are classified by the manufacturer as 'material' (מהותי), 'non-material' (לא מהותי) or 'administrative' (אדמיניסטרטיבי); it is the registration holder's responsibility to verify the nature and classification of each change with the manufacturer and file the change application accordingly. Combination rules: several material changes, or material combined with non-material/administrative, are filed as one 'material' application; non-material combined with administrative is filed as 'non-material' (one row for the highest-ranked change). An EU-reclassification increase in risk class requires a 'material' change application. Categories marked '^V' in the change procedure may be filed through the fast 'non-material' channel despite being manufacturer-classified material.

When filing a renewal application (regular or fast track), only 'non-material' and/or 'administrative' change requests may be bundled in addition, with the appropriate declaration wording attached.

One registration-change request may include multiple changes if each is clearly described in the cover letter. An open change request must finish before another change or renewal request. These rules support cumulative brand/name/address/actual-REF assessment, but a transfer of registration holder follows separate ownership instructions. A genuine new legal manufacturer must be assessed against current manufacturer/conformity evidence rather than assumed to satisfy the same-company administrative row.

A change file includes the completed application PDF, a short explanation of the nature and reason for the change, and the Annex A supporting documents where information differs from the original file. Include manufacturer explanation for an adverse event/FSCA and the appropriate holder declaration: regular-route declaration or fast-route lawyer-affirmed affidavit. Complete all registered device/model and regulatory-certificate details, not only the changed REF or newly added model.

ILS 0

Per application

The Ministry page instructs applicants to enter ILS 0 in the payment field.

Registration Regulations 6(b) expressly applies Regulation 5(a)–(c) to registration-change decisions: decision within 120 days of filing, with the period awaiting requested additional data added to that period; after approval, registration certificate within three working days of the decision. This is a change-specific statutory framework, not a promise that every combined transfer or fast-track case takes 120 days.

For eligible fast changes, REG-2024/06 lists administrative and non-material changes at up to 10 working days. Material changes are up to 45 working days in fast 1 (FDA Class II, EU IIa or corresponding IVD self-test/B categories), or up to 60 working days in fast 2 (EU IIb or corresponding IVD List B/C with the required independent approvals). The Class III table has no material-change fast option. Select the actual reference approval, class and change channel; do not substitute a new-registration clock.

Registration Regulation23 requires the trade name, manufacturer and country of manufacture, holder name/address/public contact and the other prescribed identity/safety particulars on packaging or the enclosed leaflet as directed. The general three-language rule is Hebrew, Arabic and English; a non-home-use exemption from some or all language particulars requires the director’s grant on request. A brand, name or holder change must keep the approved label identity consistent.

Under Registration Regulation18 the director may, on the registration holder’s request, issue a certificate that a specified device is registered and permitted to be marketed in Israel. This supports a CFS for the current registration/holder particulars; it does not prescribe automatic reissuance, a change-specific CFS fee, a processing clock or permission for the successor to use an outdated certificate.