Change control by country

outcomes: notification or administrative update; prior approval amendment or variation · description: A dedicated amendment service exists; event level classification still needs source extraction.

outcomes: notification or administrative update; prior approval amendment or variation; new registration or new application · description: An ARTG variation is limited to the same kind of device.

change creating a different kind of medical device; significant intended purpose change; legal manufacturer change

outcomes: notification or administrative update; prior approval amendment or variation; new registration or new application · description: Reference state amendment may require approval in concerned Member States; notification route does not.

changes meeting EAEU paragraph 67 new registration conditions

outcomes: notification or administrative update; prior approval amendment or variation; new registration or new application · description: Renewal and change are separate transactions.

changes outside permitted post registration categories or creating a new device

The marketed product must correspond to the ANVISA authorized product; changes require prior agency authorization.

outcomes: internal documentation only; prior approval amendment or variation; new registration or new application · description: Non significant changes stay in QMS and annual reporting; significant Class III/IV changes require amendment before sale.

new device licence type; specified Class II IV identity changes

outcomes: notification or administrative update; prior approval amendment or variation; new registration or new application · description: Substantial design/material/process/scope/use changes possibly affecting safety/effectiveness require change registration; other changes may be filed/reported.

changes amounting to a new product beyond registered device identity

significant change affecting safety/effectiveness; specified design/material/energy/manufacturing changes

An existing registration or marketing permit cannot be modified when a significant device change may affect safety or effectiveness, including specified design, material, energy source, or manufacturing process changes.

outcomes: prior approval amendment or variation; new registration or new application · description: Post registration services include holder, manufacturer, indication, label, model/family and distributor changes.

route defined changes outside post registration scope

changes listed by ARCSA as requiring a new sanitary registration

outcomes: internal documentation only; notification or administrative update; prior approval amendment or variation; new registration or new application · description: Manufacturer QMS and notified body significant change procedures are route and certificate specific.

new device identity or conformity assessment outside current certificate/technical documentation

outcomes: notification or administrative update; prior approval amendment or variation; new registration or new application · description: Major changes require prior approval; minor changes are notified.

MDD may require a new application based on the submitted change

outcomes: notification or administrative update; prior approval amendment or variation; new registration or new application · description: Major changes require prior approval; post approval changes and retention are separate submissions.

changes outside the licensed product and major change framework

outcomes: notification or administrative update; new registration or new application · description: Minor changes include limited size/package/label/tax number events; the guide should be checked against current implementing rules.

product/manufacturer/distributor changes; functional specification or formula changes outside minor scope

outcomes: prior approval amendment or variation; new registration or new application · description: Official fee categories confirm changes to indication, device/manufacturer name and foreign manufacturer's representative.

outcomes: notification or administrative update; prior approval amendment or variation; new registration or new application · description: Use PMDA pre consultation to classify ambiguous changes.

changes classified as a new application rather than partial/minor change

outcomes: notification or administrative update; prior approval amendment or variation; new registration or new application · description: Ownership/AR change is a defined transfer process, distinct from technical changes.

expired certificate; changes outside permitted change notification scope

outcomes: prior approval amendment or variation; new registration or new application · description: Administrative holder/distributor/importer changes and technical changes are separate services.

technical changes outside modification scope or new device identity

outcomes: prior approval amendment or variation; new registration or new application · description: Changed device may not be marketed until required MDB approval.

changes not approvable within the existing registration or after late renewal period

outcomes: prior approval amendment or variation; new registration or new application · description: Ownership and inclusion/deletion/change of trader/importer/distributor are listed variation events.

changes outside variation scope

outcomes: notification or administrative update; prior approval amendment or variation; new registration or new application · description: 2025 Russian rules require electronic filings and updated AR evidence.

EAEU or national rule defines the modification as a new device registration

outcomes: notification or administrative update; prior approval amendment or variation; new registration or new application · description: Material changes are updated within 10 days and non material changes within 30 days under the implementing regulation; exact prior approval effects depend on change category.

outcomes: notification or administrative update; prior approval amendment or variation · description: Changes not affecting safety/performance may be reported; other changes receive an agency decision.

outcomes: notification or administrative update; prior approval amendment or variation; new registration or new application · description: Administrative, review and technical change notification routes differ by class.

changes HSA classifies as requiring a new registration

outcomes: notification or administrative update; prior approval amendment or variation · description: Responsible person/licence holder changes are establishment licence amendments; product list updates are separate notifications.

outcomes: notification or administrative update; prior approval amendment or variation; new registration or new application · description: Device/actor/mandate database changes are not the same as notified body significant change.

legacy device becoming MDR compliant requires a new swissdamed registration with new Basic UDI DI/UDI DI where applicable

outcomes: prior approval amendment or variation; new registration or new application · description: Product name, label, materials/structure/spec/model, efficacy/use, manufacturer, site/country and licence holder have explicit change routes.

outcomes: notification or administrative update; prior approval amendment or variation; new registration or new application · description: Product and establishment change services are separate; Full CSDT transfer has its own path.

applicationFormat: Full CSDT · additionalDocuments: declaration of identicality; letter of consent; safety declaration

masterRegistrationCancelledAfterApproval: Yes · formerHolderClosureDeadlineDays: 30

outcomes: prior approval amendment or variation; new registration or new application · description: Minor variation is available only while authorization is valid or active renewal is in process.

major changes outside the amendment service

change of UK Responsible Person; legislation route change; relevant IVD status change

outcomes: internal documentation only; prior approval amendment or variation; new registration or new application · description: 510(k) has no supplement mechanism; document minor changes and submit a new 510(k) when required.

510(k): significant change in design/intended use that could significantly affect safety/effectiveness; PMA: route specific supplement/new application conditions

outcomes: notification or administrative update; new registration or new application · description: Address and other administrative changes may be notified within a defined period; change result differs by field.

Class A owner/product owner/manufacturer/country changes listed as requiring a new declaration