Saudi Arabia medical device regulations

Report significant changes within 10 days of the change, update the relevant MDMA on GHAD with Annex 1 and relevant documents, and obtain SFDA approval before trading the affected device. Notify non-significant changes within 30 days: submit Annex 1 and documents by the designated MDMA email, then update GHAD when updating or renewing; alternatively send the prescribed short description first and complete the full notification information within 90 days of the change. These are manufacturer deadlines, not an SFDA decision SLA.

Use the Medical Device Change Form (Annex 1) with the affected MDMA number, manufacturer name/address, device name/model, national listing number and risk class. Select every affected category, explain and justify the change and risk assessment, state whether it is implemented or already supplied in Saudi Arabia, classify it, and attach relevant updated technical and label documents with a signed truth/completeness declaration.

The MDMA fee table’s reduced SAR 5,000 category covers renewal, adding devices or models, changing brand name, updating the technical file, a transition-period letter and minor manufacturer name/address changes. The administrative SAR 1,100 category covers only label-only, IFU-only and advertising-material-only updates. A change of legal manufacturer name/address or risk classification attracts the full risk-class fee: A SAR 15,000, B SAR 19,000, C SAR 21,000 and D SAR 23,000. Classify the actual SFDA request; a same-company description does not by itself decide whether the minor or legal-manufacturer fee category applies.

The responsible legal manufacturer’s name and address must remain consistent with the authorization and label evidence. Import shipment records and the shipment declaration must identify the product and manufacturer consistently with the approved information; imported labels must correspond to the labels submitted to SFDA. Evaluate a brand, name, address, REF or successor change across those linked documents before affected supply.

A new UDI-DI is required for a change that can cause misidentification or ambiguity in traceability, including the listed brand/trade-name and version/model changes. Catalogue number, version/model and primary UDI-DI are separate Saudi-DI data fields. An orderable REF/SMN change is therefore assessed by its actual field and device effect; it is not automatically a model or UDI-DI change. For changes not requiring a new UDI-DI, update the relevant Saudi-DI record within 10 working days.

Saudi CFS is a separate export service for a licensed manufacturer with MDMA: submit the Annex 6 request/declaration, manufacturer licence and MDMA verification. CFS validity is one year taking MDMA validity into account; Annex 6 requires informing SFDA within 10 calendar days of a change to submitted information. Shipment clearance instead uses Annex 8 and invoice/product/model/part/lot details. A change in a CFS field is not automatically a one-for-one replacement permission or an MDMA ownership transfer.

Annex 1 records multiple affected change categories and the manufacturer must classify the complete change. This supports describing all linked brand/name/address/REF changes and their cumulative risk in the relevant MDMA update. It does not establish that a true legal-person transfer, AR/establishment change, Saudi-DI update, CFS or chemical permission can all be processed as one application with one fee or clock. Significant affected-device supply must await SFDA approval; coordinate other records with the accepted manufacturer and representation route.

Report significant changes within 10 days of the change, update the relevant MDMA on GHAD with Annex 1 and relevant documents, and obtain SFDA approval before trading the affected device. Notify non-significant changes within 30 days: submit Annex 1 and documents by the designated MDMA email, then update GHAD when updating or renewing; alternatively send the prescribed short description first and complete the full notification information within 90 days of the change. These are manufacturer deadlines, not an SFDA decision SLA.

Use the Medical Device Change Form (Annex 1) with the affected MDMA number, manufacturer name/address, device name/model, national listing number and risk class. Select every affected category, explain and justify the change and risk assessment, state whether it is implemented or already supplied in Saudi Arabia, classify it, and attach relevant updated technical and label documents with a signed truth/completeness declaration.

The MDMA fee table’s reduced SAR 5,000 category covers renewal, adding devices or models, changing brand name, updating the technical file, a transition-period letter and minor manufacturer name/address changes. The administrative SAR 1,100 category covers only label-only, IFU-only and advertising-material-only updates. A change of legal manufacturer name/address or risk classification attracts the full risk-class fee: A SAR 15,000, B SAR 19,000, C SAR 21,000 and D SAR 23,000. Classify the actual SFDA request; a same-company description does not by itself decide whether the minor or legal-manufacturer fee category applies.

The responsible legal manufacturer’s name and address must remain consistent with the authorization and label evidence. Import shipment records and the shipment declaration must identify the product and manufacturer consistently with the approved information; imported labels must correspond to the labels submitted to SFDA. Evaluate a brand, name, address, REF or successor change across those linked documents before affected supply.

A new UDI-DI is required for a change that can cause misidentification or ambiguity in traceability, including the listed brand/trade-name and version/model changes. Catalogue number, version/model and primary UDI-DI are separate Saudi-DI data fields. An orderable REF/SMN change is therefore assessed by its actual field and device effect; it is not automatically a model or UDI-DI change. For changes not requiring a new UDI-DI, update the relevant Saudi-DI record within 10 working days.

Saudi CFS is a separate export service for a licensed manufacturer with MDMA: submit the Annex 6 request/declaration, manufacturer licence and MDMA verification. CFS validity is one year taking MDMA validity into account; Annex 6 requires informing SFDA within 10 calendar days of a change to submitted information. Shipment clearance instead uses Annex 8 and invoice/product/model/part/lot details. A change in a CFS field is not automatically a one-for-one replacement permission or an MDMA ownership transfer.

Annex 1 records multiple affected change categories and the manufacturer must classify the complete change. This supports describing all linked brand/name/address/REF changes and their cumulative risk in the relevant MDMA update. It does not establish that a true legal-person transfer, AR/establishment change, Saudi-DI update, CFS or chemical permission can all be processed as one application with one fee or clock. Significant affected-device supply must await SFDA approval; coordinate other records with the accepted manufacturer and representation route.

Report significant changes within 10 days of the change, update the relevant MDMA on GHAD with Annex 1 and relevant documents, and obtain SFDA approval before trading the affected device. Notify non-significant changes within 30 days: submit Annex 1 and documents by the designated MDMA email, then update GHAD when updating or renewing; alternatively send the prescribed short description first and complete the full notification information within 90 days of the change. These are manufacturer deadlines, not an SFDA decision SLA.

Use the Medical Device Change Form (Annex 1) with the affected MDMA number, manufacturer name/address, device name/model, national listing number and risk class. Select every affected category, explain and justify the change and risk assessment, state whether it is implemented or already supplied in Saudi Arabia, classify it, and attach relevant updated technical and label documents with a signed truth/completeness declaration.

The MDMA fee table’s reduced SAR 5,000 category covers renewal, adding devices or models, changing brand name, updating the technical file, a transition-period letter and minor manufacturer name/address changes. The administrative SAR 1,100 category covers only label-only, IFU-only and advertising-material-only updates. A change of legal manufacturer name/address or risk classification attracts the full risk-class fee: A SAR 15,000, B SAR 19,000, C SAR 21,000 and D SAR 23,000. Classify the actual SFDA request; a same-company description does not by itself decide whether the minor or legal-manufacturer fee category applies.

The responsible legal manufacturer’s name and address must remain consistent with the authorization and label evidence. Import shipment records and the shipment declaration must identify the product and manufacturer consistently with the approved information; imported labels must correspond to the labels submitted to SFDA. Evaluate a brand, name, address, REF or successor change across those linked documents before affected supply.

A new UDI-DI is required for a change that can cause misidentification or ambiguity in traceability, including the listed brand/trade-name and version/model changes. Catalogue number, version/model and primary UDI-DI are separate Saudi-DI data fields. An orderable REF/SMN change is therefore assessed by its actual field and device effect; it is not automatically a model or UDI-DI change. For changes not requiring a new UDI-DI, update the relevant Saudi-DI record within 10 working days.

Saudi CFS is a separate export service for a licensed manufacturer with MDMA: submit the Annex 6 request/declaration, manufacturer licence and MDMA verification. CFS validity is one year taking MDMA validity into account; Annex 6 requires informing SFDA within 10 calendar days of a change to submitted information. Shipment clearance instead uses Annex 8 and invoice/product/model/part/lot details. A change in a CFS field is not automatically a one-for-one replacement permission or an MDMA ownership transfer.

Annex 1 records multiple affected change categories and the manufacturer must classify the complete change. This supports describing all linked brand/name/address/REF changes and their cumulative risk in the relevant MDMA update. It does not establish that a true legal-person transfer, AR/establishment change, Saudi-DI update, CFS or chemical permission can all be processed as one application with one fee or clock. Significant affected-device supply must await SFDA approval; coordinate other records with the accepted manufacturer and representation route.

Report significant changes within 10 days of the change, update the relevant MDMA on GHAD with Annex 1 and relevant documents, and obtain SFDA approval before trading the affected device. Notify non-significant changes within 30 days: submit Annex 1 and documents by the designated MDMA email, then update GHAD when updating or renewing; alternatively send the prescribed short description first and complete the full notification information within 90 days of the change. These are manufacturer deadlines, not an SFDA decision SLA.

A new UDI-DI is required for a change that can cause misidentification or ambiguity in traceability, including the listed brand/trade-name and version/model changes. Catalogue number, version/model and primary UDI-DI are separate Saudi-DI data fields. An orderable REF/SMN change is therefore assessed by its actual field and device effect; it is not automatically a model or UDI-DI change. For changes not requiring a new UDI-DI, update the relevant Saudi-DI record within 10 working days.

Use the Medical Device Change Form (Annex 1) with the affected MDMA number, manufacturer name/address, device name/model, national listing number and risk class. Select every affected category, explain and justify the change and risk assessment, state whether it is implemented or already supplied in Saudi Arabia, classify it, and attach relevant updated technical and label documents with a signed truth/completeness declaration.

The MDMA fee table’s reduced SAR 5,000 category covers renewal, adding devices or models, changing brand name, updating the technical file, a transition-period letter and minor manufacturer name/address changes. The administrative SAR 1,100 category covers only label-only, IFU-only and advertising-material-only updates. A change of legal manufacturer name/address or risk classification attracts the full risk-class fee: A SAR 15,000, B SAR 19,000, C SAR 21,000 and D SAR 23,000. Classify the actual SFDA request; a same-company description does not by itself decide whether the minor or legal-manufacturer fee category applies.

The responsible legal manufacturer’s name and address must remain consistent with the authorization and label evidence. Import shipment records and the shipment declaration must identify the product and manufacturer consistently with the approved information; imported labels must correspond to the labels submitted to SFDA. Evaluate a brand, name, address, REF or successor change across those linked documents before affected supply.

Saudi CFS is a separate export service for a licensed manufacturer with MDMA: submit the Annex 6 request/declaration, manufacturer licence and MDMA verification. CFS validity is one year taking MDMA validity into account; Annex 6 requires informing SFDA within 10 calendar days of a change to submitted information. Shipment clearance instead uses Annex 8 and invoice/product/model/part/lot details. A change in a CFS field is not automatically a one-for-one replacement permission or an MDMA ownership transfer.

Annex 1 records multiple affected change categories and the manufacturer must classify the complete change. This supports describing all linked brand/name/address/REF changes and their cumulative risk in the relevant MDMA update. It does not establish that a true legal-person transfer, AR/establishment change, Saudi-DI update, CFS or chemical permission can all be processed as one application with one fee or clock. Significant affected-device supply must await SFDA approval; coordinate other records with the accepted manufacturer and representation route.

Report significant changes within 10 days of the change, update the relevant MDMA on GHAD with Annex 1 and relevant documents, and obtain SFDA approval before trading the affected device. Notify non-significant changes within 30 days: submit Annex 1 and documents by the designated MDMA email, then update GHAD when updating or renewing; alternatively send the prescribed short description first and complete the full notification information within 90 days of the change. These are manufacturer deadlines, not an SFDA decision SLA.

The manufacturer is responsible for obtaining MDMA, and the authorization is issued in the manufacturer’s name. Labels must identify the responsible legal manufacturer. A genuine transfer of legal-manufacturer responsibility requires assessment of the successor’s manufacturer identity, updated conformity/technical evidence, MDMA route and representation; a rename of the same company or a change of authorised representative does not by itself establish succession to another legal person’s MDMA.

A foreign manufacturer’s authorised-representative arrangement is a separate licensed role. On termination the manufacturer must appoint a replacement immediately, transfer relevant obligations and notify SFDA. The outgoing representative’s responsibilities continue until replacement or until the products are no longer marketed or in use, under the implementing regulation. This continuity rule does not transfer legal-manufacturer ownership of MDMA.

Use the Medical Device Change Form (Annex 1) with the affected MDMA number, manufacturer name/address, device name/model, national listing number and risk class. Select every affected category, explain and justify the change and risk assessment, state whether it is implemented or already supplied in Saudi Arabia, classify it, and attach relevant updated technical and label documents with a signed truth/completeness declaration.

The MDMA fee table’s reduced SAR 5,000 category covers renewal, adding devices or models, changing brand name, updating the technical file, a transition-period letter and minor manufacturer name/address changes. The administrative SAR 1,100 category covers only label-only, IFU-only and advertising-material-only updates. A change of legal manufacturer name/address or risk classification attracts the full risk-class fee: A SAR 15,000, B SAR 19,000, C SAR 21,000 and D SAR 23,000. Classify the actual SFDA request; a same-company description does not by itself decide whether the minor or legal-manufacturer fee category applies.

The responsible legal manufacturer’s name and address must remain consistent with the authorization and label evidence. Import shipment records and the shipment declaration must identify the product and manufacturer consistently with the approved information; imported labels must correspond to the labels submitted to SFDA. Evaluate a brand, name, address, REF or successor change across those linked documents before affected supply.

A new UDI-DI is required for a change that can cause misidentification or ambiguity in traceability, including the listed brand/trade-name and version/model changes. Catalogue number, version/model and primary UDI-DI are separate Saudi-DI data fields. An orderable REF/SMN change is therefore assessed by its actual field and device effect; it is not automatically a model or UDI-DI change. For changes not requiring a new UDI-DI, update the relevant Saudi-DI record within 10 working days.

Saudi CFS is a separate export service for a licensed manufacturer with MDMA: submit the Annex 6 request/declaration, manufacturer licence and MDMA verification. CFS validity is one year taking MDMA validity into account; Annex 6 requires informing SFDA within 10 calendar days of a change to submitted information. Shipment clearance instead uses Annex 8 and invoice/product/model/part/lot details. A change in a CFS field is not automatically a one-for-one replacement permission or an MDMA ownership transfer.

Annex 1 records multiple affected change categories and the manufacturer must classify the complete change. This supports describing all linked brand/name/address/REF changes and their cumulative risk in the relevant MDMA update. It does not establish that a true legal-person transfer, AR/establishment change, Saudi-DI update, CFS or chemical permission can all be processed as one application with one fee or clock. Significant affected-device supply must await SFDA approval; coordinate other records with the accepted manufacturer and representation route.

Report significant changes within 10 days of the change, update the relevant MDMA on GHAD with Annex 1 and relevant documents, and obtain SFDA approval before trading the affected device. Notify non-significant changes within 30 days: submit Annex 1 and documents by the designated MDMA email, then update GHAD when updating or renewing; alternatively send the prescribed short description first and complete the full notification information within 90 days of the change. These are manufacturer deadlines, not an SFDA decision SLA.

The manufacturer is responsible for obtaining MDMA, and the authorization is issued in the manufacturer’s name. Labels must identify the responsible legal manufacturer. A genuine transfer of legal-manufacturer responsibility requires assessment of the successor’s manufacturer identity, updated conformity/technical evidence, MDMA route and representation; a rename of the same company or a change of authorised representative does not by itself establish succession to another legal person’s MDMA.

A foreign manufacturer’s authorised-representative arrangement is a separate licensed role. On termination the manufacturer must appoint a replacement immediately, transfer relevant obligations and notify SFDA. The outgoing representative’s responsibilities continue until replacement or until the products are no longer marketed or in use, under the implementing regulation. This continuity rule does not transfer legal-manufacturer ownership of MDMA.

Use the Medical Device Change Form (Annex 1) with the affected MDMA number, manufacturer name/address, device name/model, national listing number and risk class. Select every affected category, explain and justify the change and risk assessment, state whether it is implemented or already supplied in Saudi Arabia, classify it, and attach relevant updated technical and label documents with a signed truth/completeness declaration.

The MDMA fee table’s reduced SAR 5,000 category covers renewal, adding devices or models, changing brand name, updating the technical file, a transition-period letter and minor manufacturer name/address changes. The administrative SAR 1,100 category covers only label-only, IFU-only and advertising-material-only updates. A change of legal manufacturer name/address or risk classification attracts the full risk-class fee: A SAR 15,000, B SAR 19,000, C SAR 21,000 and D SAR 23,000. Classify the actual SFDA request; a same-company description does not by itself decide whether the minor or legal-manufacturer fee category applies.

The responsible legal manufacturer’s name and address must remain consistent with the authorization and label evidence. Import shipment records and the shipment declaration must identify the product and manufacturer consistently with the approved information; imported labels must correspond to the labels submitted to SFDA. Evaluate a brand, name, address, REF or successor change across those linked documents before affected supply.

A new UDI-DI is required for a change that can cause misidentification or ambiguity in traceability, including the listed brand/trade-name and version/model changes. Catalogue number, version/model and primary UDI-DI are separate Saudi-DI data fields. An orderable REF/SMN change is therefore assessed by its actual field and device effect; it is not automatically a model or UDI-DI change. For changes not requiring a new UDI-DI, update the relevant Saudi-DI record within 10 working days.

Saudi CFS is a separate export service for a licensed manufacturer with MDMA: submit the Annex 6 request/declaration, manufacturer licence and MDMA verification. CFS validity is one year taking MDMA validity into account; Annex 6 requires informing SFDA within 10 calendar days of a change to submitted information. Shipment clearance instead uses Annex 8 and invoice/product/model/part/lot details. A change in a CFS field is not automatically a one-for-one replacement permission or an MDMA ownership transfer.

Annex 1 records multiple affected change categories and the manufacturer must classify the complete change. This supports describing all linked brand/name/address/REF changes and their cumulative risk in the relevant MDMA update. It does not establish that a true legal-person transfer, AR/establishment change, Saudi-DI update, CFS or chemical permission can all be processed as one application with one fee or clock. Significant affected-device supply must await SFDA approval; coordinate other records with the accepted manufacturer and representation route.