Economic-operator roles by country

archetype: licensed importer as applicant · name: Albanian wholesale medical device trader/applicant · required for foreign: yes · registration relation: submits and is local applicant · importer relation: usually same or linked · distributor relation: licensed wholesale role · combination: allowed with required wholesale authorization

archetype: marketing authorization holder or registrant · name: ANMAT authorized importer/registration holder · required for foreign: yes · registration relation: holds or applies for registration · importer relation: often same · distributor relation: may be separate · combination: allowed subject to establishment authorization

archetype: sponsor or local market entry owner · name: Australian sponsor · required for foreign: yes · registration relation: owns ARTG inclusion and market entry obligations · importer relation: may be same but each sponsor importer needs own entry · distributor relation: can be separate · combination: allowed

path code: sponsor transfer or new ARTG · fresh registration: no if valid transfer yes if no transfer · minimum handover: current sponsor consent or qualifying evidence; manufacturer evidence linkage; ARTG records; complaints/vigilance/recalls; stock and supply records · notes: New sponsor notifies TGA within 3 months; if sponsorship is not transferred the new sponsor obtains its own ARTG inclusion.

archetype: marketing authorization holder or registrant · name: Brazilian registration holder · required for foreign: yes · registration relation: holds ANVISA notification or registration · importer relation: may be same or third party with holder authorization · distributor relation: may be separate · combination: allowed

path code: holder transfer or regulatory change route · fresh registration: route dependent · minimum handover: manufacturer authorization; holder transfer documents; dossier and ANVISA history; complaints/vigilance/recalls; Portuguese labels; DDR/import authorizations · notes: The holder and physical importer can differ; changing one does not automatically change the other.

path code: no AR transfer update manufacturer or MDEL parties · fresh registration: not applicable · minimum handover: MDL records; MDEL supply chain records; complaints/recalls; bilingual labels · notes: A Canadian importer/distributor change is not an AR change and does not by itself transfer the manufacturer held MDL.

archetype: registration agent but foreign manufacturer remains registrant · name: China domestic agent for overseas registrant · required for foreign: yes · registration relation: assists foreign registrant lifecycle duties · importer relation: can be separate · distributor relation: can be separate · combination: allowed but roles remain distinct

path code: agent change filing · fresh registration: no if only agent change · minimum handover: new agency agreement; termination/effective dates; registration/file records; complaints/adverse events/recalls; Chinese labels and UDI records; import channels · notes: Beijing's 2026 implementation gives a practical 5 working day notice and 30 working day filing sequence; treat it as Beijing specific until a national operational rule is confirmed.

archetype: marketing authorization holder or registrant · name: Colombian registration holder · required for foreign: yes · registration relation: holds INVIMA registration · importer relation: can be added or changed as modification · distributor relation: can be separate · combination: allowed

path code: holder assignment modification · fresh registration: usually no for valid assignment · minimum handover: assignment; manufacturer relationship documents; registration dossier; importer list; complaints/vigilance/recalls; Spanish labels · notes: Holder assignment and importer changes are distinct modification events.

path code: post registration holder or legal representative change · fresh registration: usually no for listed change · minimum handover: manufacturer authorization; holder/legal representative records; registration file; local distributors; complaints/recalls; Spanish labels · notes: Exact change type determines whether amendment or new registration is required.

archetype: licensed importer as applicant · name: Egyptian importing company/local registration applicant · required for foreign: yes · registration relation: applies with foreign manufacturer authorization · importer relation: same or named local importer · distributor relation: one or more distributors may be downstream · combination: allowed subject to licensing

archetype: manufacturer mandated authorized representative · name: EU Authorized Representative · required for foreign: yes for non EU manufacturer · registration relation: mandated legal operator not normally product licence holder · importer relation: separate economic operator · distributor relation: separate economic operator · combination: may combine if each role obligation is met

path code: three party transition agreement and regulatory updates · fresh registration: no generic fresh product registration · minimum handover: termination/start dates; outgoing label run off arrangement; transfer of documents; confidentiality/IP; complaints and incident forwarding; EUDAMED/member state updates; label/IFU updates · notes: Article 12 specifies the minimum arrangement among manufacturer, outgoing AR where practicable, and incoming AR.

path code: MDIS takeover application · fresh registration: no if takeover approved · minimum handover: manufacturer designation letter; listing access and dossier; complaints/adverse events/recalls; labels and special listing information; importer/distributor records · notes: MDIS expressly supports takeover, distinct from ordinary change and renewal.

archetype: manufacturer mandated authorized representative · name: Indian Authorized Agent · required for foreign: yes · registration relation: holds or submits import licence on behalf of foreign manufacturer · importer relation: agent must have eligible sale/manufacture/wholesale licence · distributor relation: may be same or separate · combination: allowed subject to licensing

path code: post approval agent change with fresh power of attorney · fresh registration: usually no if approved change · minimum handover: fresh power of attorney; old agent termination; licence and dossier records; post market and complaint records; import inventory; label updates · notes: A correctly processed agent change can retain the licence number; do not wait for the five year retention filing if change approval is required earlier.

path code: new registration risk for distributor change · fresh registration: often yes · minimum handover: new exclusive LoA; old authorization termination; dossier and authorization; inventory/import records; complaints/recalls; Bahasa labels · notes: Treat distributor holder change as a potential new application, not a simple EU style AR update.

archetype: licensed importer as applicant · name: Israeli importer/AMAR registration holder · required for foreign: yes · registration relation: submits and holds local registration · importer relation: usually same · distributor relation: may be same or downstream · combination: allowed

path code: registration change for importer or foreign representative · fresh registration: route dependent · minimum handover: manufacturer declaration and authorization; previous AMAR approval; registration file; complaints/recalls; import records; Hebrew/Arabic user materials where applicable · notes: Exact transfer sequence is not yet exposed as a current English service.

path code: MAH transfer or new approval route requires product specific review · fresh registration: route dependent · minimum handover: approval/certification files; QMS and GVP records; complaints/adverse events/recalls; manufacturer registrations; Japanese labels; distribution and inventory records · notes: Changing a filing intermediary is not the same as transferring the MAH/DMAH.

archetype: marketing authorization holder or registrant · name: Malaysian Authorized Representative · required for foreign: yes · registration relation: local registration holder · importer relation: separate licensed role appointed by AR · distributor relation: separate licensed role appointed by AR or manufacturer · combination: separate role licences required even if same entity

path code: change ownership or AR transfer · fresh registration: no if transfer approved · minimum handover: manufacturer appointment and old termination; distribution and complaint records; registration certificates; post market/vigilance records; new AR relabelling; stock transition · notes: Old stock must carry the new AR information before placement on the market.

archetype: marketing authorization holder or registrant · name: Mexican registration holder · required for foreign: yes · registration relation: holds COFEPRIS registration · importer relation: may be holder or named importer · distributor relation: may be holder or named distributor · combination: allowed

path code: administrative modification or assignment of rights · fresh registration: usually no for valid assignment · minimum handover: assignment of rights; manufacturer authorization; registration dossier; importer/distributor changes; complaints/vigilance; Spanish labels; inventory transition · notes: A holder transfer is an administrative change only if the facts fit the service; technical changes may need separate filing.

archetype: licensed importer as applicant · name: Pakistan licensed medical device importer · required for foreign: yes · registration relation: applies for imported device registration after establishment licence · importer relation: same · distributor relation: may be same or downstream · combination: allowed subject to licence

path code: prior approval change or fresh application · fresh registration: route dependent · minimum handover: manufacturer authorization; establishment licence; registration file; import records; complaints/vigilance/recalls; label updates · notes: No separate EU style AR archetype was verified; model the importer/applicant explicitly.

archetype: marketing authorization holder or registrant · name: Philippine MAH/trader/importer/distributor · required for foreign: yes · registration relation: local licensed entity holds authorization · importer relation: may be same · distributor relation: may be same; MAH may be manufacturer/trader/distributor · combination: allowed

path code: ownership or trader importer distributor variation · fresh registration: usually no if approved variation · minimum handover: termination/deed of assignment; manufacturer agreement with new party; valid LTO; original authorization; labels; complaint/recall records; inventory · notes: Variation and renewal should not be collapsed into one filing.

archetype: manufacturer mandated authorized representative · name: Russian authorized representative of manufacturer · required for foreign: yes · registration relation: represents manufacturer for circulation conformity and registration · importer relation: separate or combined commercial role · distributor relation: separate or combined · combination: allowed if licensed and mandate covers duties

path code: registration dossier amendment and new power document · fresh registration: usually no if eligible amendment · minimum handover: new authority document meeting 2025 powers; old mandate termination; registration dossier; vigilance/complaints/recalls; Russian labels; importer/distributor network · notes: A pre 2025 power document may not prove authority for actions under the 2025 rules.

archetype: manufacturer mandated authorized representative · name: Saudi Authorized Representative · required for foreign: yes · registration relation: local authorized representative for manufacturer and MDMA services · importer relation: distinct licensed role · distributor relation: distinct licensed role · combination: possible only with each required licence

path code: GHAD MDMA transfer · fresh registration: no if transfer approved · minimum handover: new AR authorization; old AR termination; MDMA transfer request; dossier; vigilance/complaints/recalls; Arabic/English labels; importer/distributor links · notes: SFDA provides an explicit online transfer service.

path code: statutory three party transfer agreement · fresh registration: no if change registered · minimum handover: termination/start dates; label use of outgoing representative; document transfer; confidentiality/IP; complaints and incidents; registration amendment · notes: Law mirrors a detailed EU style three party change contract and requires prompt filing by manufacturer or new AR.

archetype: marketing authorization holder or registrant · name: Singapore registrant · required for foreign: yes · registration relation: local registration holder · importer relation: separate importer dealer licence · distributor relation: separate wholesaler dealer licence · combination: allowed if each licence is held

path code: GN24 change of registrant · fresh registration: no if change approved · minimum handover: old and new registrant forms; manufacturer authorization; SMDR/dossier access; complaints/adverse events/recalls; dealer licence and supply records; labels · notes: Effective only after HSA approval; the incoming registrant assumes regulatory obligations and system access.

archetype: responsible natural person within licensed establishment · name: South African Authorized Representative/responsible person within licence holder · required for foreign: yes as local establishment responsibility · registration relation: responsible person for licensed establishment not generic product holder · importer relation: manufacturer/importer/distributor establishment roles licensed · distributor relation: licensed distribution role · combination: roles can coexist in establishment if licensed

path code: establishment licence amendment · fresh registration: new product registration not applicable currently · minimum handover: new responsible person qualifications; licence amendment; product list; complaints/vigilance/recalls; quality records; distribution records · notes: This AR is a responsible natural person, not the EU AR archetype.

archetype: licensed importer as applicant · name: Korean licensed importer/product authorization holder · required for foreign: yes · registration relation: foreign device enters through licensed importer · importer relation: same core local role · distributor relation: may be separate · combination: allowed subject to business licences

archetype: manufacturer mandated authorized representative · name: Swiss Authorized Representative (CH REP) · required for foreign: yes for foreign manufacturer · registration relation: registers mandated devices and represents manufacturer · importer relation: separate registered actor links to device · distributor relation: separate supply chain role · combination: may combine if each role is registered and fulfilled

path code: swissdamed mandate transfer · fresh registration: no generic fresh conformity assessment · minimum handover: mandate transfer request; old/new AR acceptance; device registrations; complaints/vigilance/recalls; CH REP label update; importer links · notes: Swissdamed supports mandate transfer; importers link themselves to already registered devices and do not register devices.

archetype: marketing authorization holder or registrant · name: Taiwan medical device licence holder · required for foreign: yes · registration relation: local licence holder · importer relation: often same or named importer · distributor relation: may be separate · combination: allowed

path code: joint licence holder transfer · fresh registration: no if transfer approved · minimum handover: joint old/new filing; manufacturer authorization terminating old and appointing new; licence and dossier; QMS evidence; complaints/recalls; Chinese labels; import inventory · notes: Holder transfer is expressly listed and requires coordinated old/new/manufacturer evidence.

path code: registration dossier transfer with consent · fresh registration: new application using transferred dossier · minimum handover: declaration of identicality; consent to dossier transfer; new manufacturer LoA; registration dossier; complaints/recalls; Thai labels; import inventory · notes: Transfer facilitates a new application; it is not merely editing the old holder field.

archetype: marketing authorization holder or registrant · name: UAE local medical warehouse/marketing office applicant and named local agent · required for foreign: yes · registration relation: local eligible applicant holds or manages authorization · importer relation: import by local agent named in MA · distributor relation: can be separate licensed channel · combination: allowed subject to licences

path code: authorization amendment or new application not fully verified · fresh registration: route dependent · minimum handover: new agency appointment; old agency termination; marketing authorization dossier; import permit records; complaints/vigilance/recalls; Arabic/English labels; inventory · notes: Specific local agent transfer service was not confirmed; treat as a validation gap.

archetype: responsible person · name: UK Responsible Person · required for foreign: yes for non UK manufacturer · registration relation: registers devices for foreign manufacturer · importer relation: may be same or separate; separate importer informs manufacturer/UKRP · distributor relation: may be same; non importing distributor need not register · combination: allowed

archetype: communication liaison only · name: U.S. agent · required for foreign: yes for foreign establishment · registration relation: communications and inspection liaison not 510k holder · importer relation: initial importer is distinct role · distributor relation: distributor is distinct · combination: may be same company but legal roles differ

path code: FURLS DRM agent update and confirmation · fresh registration: no · minimum handover: FURLS update; new agent consent within 10 business days; FDA communications; inspection scheduling contacts; importer/distributor contacts · notes: The U.S. agent does not assume MDR reporting or 510(k) responsibilities merely by appointment.

path code: field specific new declaration or notification · fresh registration: route dependent · minimum handover: manufacturer authorization; CFS and warranty documents; circulation dossier; complaints/vigilance/recalls; Vietnamese labels; import/distribution records · notes: A holder/manufacturer/country change may require a new declaration; address changes may be notification only.