Reliance & recognition by country
Which foreign decisions or evidence can be reused, with what effect and conditions?
| Market | Source-linked requirements | Official sources | Last checked |
|---|---|---|---|
| 🇦🇷 Argentina ANMAT All country facts → | Medical Device Single Audit Program — qms audit reliance target: geo:arg · sourceApproval: Medical Device Single Audit Program · edgeType: qms audit reliance · marketAccessStrength: evidence only · regulatoryLayer: qms audit · localApplicationRequired: Yes · targetDecisionRetained: Yes | 2026-08-13 | |
| 🇦🇺 Australia TGA All country facts → | Medical Device Single Audit Program — qms audit reliance target: geo:aus · sourceApproval: Medical Device Single Audit Program · edgeType: qms audit reliance · marketAccessStrength: evidence only · regulatoryLayer: qms audit · localApplicationRequired: Yes · targetDecisionRetained: Yes EU CE under MDR/IVDR — evidence reuse target: geo:aus · sourceApproval: EU CE under MDR/IVDR · edgeType: evidence reuse · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes Health Canada medical-device licence — evidence reuse target: geo:aus · sourceApproval: Health Canada medical device licence · edgeType: evidence reuse · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes Japan MHLW/PMDA Ninsho or Shonin — evidence reuse target: geo:aus · sourceApproval: Japan MHLW/PMDA Ninsho or Shonin · edgeType: evidence reuse · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes Singapore HSA product registration — evidence reuse target: geo:aus · sourceApproval: Singapore HSA product registration · edgeType: evidence reuse · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes Great Britain UKCA — evidence reuse target: geo:aus · sourceApproval: Great Britain UKCA · edgeType: evidence reuse · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes US FDA 510(k), De Novo, or PMA — evidence reuse target: geo:aus · sourceApproval: US FDA 510(k), De Novo, or PMA · edgeType: evidence reuse · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes | 2026-08-13 | |
| 🇦🇹 Austria BASG All country facts → | EU CE under MDR/IVDR — single market validity target: geo:aut · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No Türkiye CE under aligned MDR/IVDR — customs union free circulation target: geo:aut · sourceApproval: Türkiye CE under aligned MDR/IVDR · edgeType: customs union free circulation · marketAccessStrength: direct with local obligations · regulatoryLayer: product marketing · localApplicationRequired: No · targetDecisionRetained: No | 2026-08-13 | |
| 🇧🇩 Bangladesh DGDA All country facts → | WHO Prequalification of IVDs — collaborative abridged registration target: geo:bgd · sourceApproval: WHO Prequalification of IVDs · edgeType: collaborative abridged registration · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes · timeTargetDays: 90 · timeBasis: working days after access to all relevant information | 2026-08-13 | |
| 🇧🇾 Belarus Ministry of Health All country facts → | EAEU common medical-device registration — common registration scope target: geo:blr · sourceApproval: EAEU common medical device registration · edgeType: common registration scope · marketAccessStrength: direct if target selected · regulatoryLayer: product marketing · localApplicationRequired: No · targetDecisionRetained: Yes | 2026-08-13 | |
| 🇧🇪 Belgium FAMHP All country facts → | EU CE under MDR/IVDR — single market validity target: geo:bel · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No Türkiye CE under aligned MDR/IVDR — customs union free circulation target: geo:bel · sourceApproval: Türkiye CE under aligned MDR/IVDR · edgeType: customs union free circulation · marketAccessStrength: direct with local obligations · regulatoryLayer: product marketing · localApplicationRequired: No · targetDecisionRetained: No | 2026-08-13 | |
| 🇧🇷 Brazil ANVISA All country facts → | Medical Device Single Audit Program — qms audit reliance target: geo:bra · sourceApproval: Medical Device Single Audit Program · edgeType: qms audit reliance · marketAccessStrength: evidence only · regulatoryLayer: qms audit · localApplicationRequired: Yes · targetDecisionRetained: Yes Australia TGA/ARTG market authorization evidence — optimized reliance review target: geo:bra · sourceApproval: Australia TGA/ARTG market authorization evidence · edgeType: optimized reliance review · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes Health Canada medical-device licence — optimized reliance review target: geo:bra · sourceApproval: Health Canada medical device licence · edgeType: optimized reliance review · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes Japan MHLW/PMDA Ninsho or Shonin — optimized reliance review target: geo:bra · sourceApproval: Japan MHLW/PMDA Ninsho or Shonin · edgeType: optimized reliance review · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes US FDA 510(k), De Novo, or PMA — optimized reliance review target: geo:bra · sourceApproval: US FDA 510(k), De Novo, or PMA · edgeType: optimized reliance review · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes | 2026-08-13 | |
| 🇧🇬 Bulgaria BDA All country facts → | EU CE under MDR/IVDR — single market validity target: geo:bgr · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No Türkiye CE under aligned MDR/IVDR — customs union free circulation target: geo:bgr · sourceApproval: Türkiye CE under aligned MDR/IVDR · edgeType: customs union free circulation · marketAccessStrength: direct with local obligations · regulatoryLayer: product marketing · localApplicationRequired: No · targetDecisionRetained: No | 2026-08-13 | |
| 🇨🇦 Canada Health Canada All country facts → | Medical Device Single Audit Program — qms audit reliance target: geo:can · sourceApproval: Medical Device Single Audit Program · edgeType: qms audit reliance · marketAccessStrength: evidence only · regulatoryLayer: qms audit · localApplicationRequired: Yes · targetDecisionRetained: Yes | 2026-08-13 | |
| 🇨🇳 China NMPA All country facts → | Home or manufacturing-jurisdiction marketing certificate — eligibility gate target: geo:chn · sourceApproval: Home or manufacturing jurisdiction marketing certificate · edgeType: eligibility gate · marketAccessStrength: eligibility only · regulatoryLayer: filing prerequisite · localApplicationRequired: Yes · targetDecisionRetained: Yes | 2026-08-13 | |
| 🇨🇿 Czech Republic SÚKL All country facts → | EU CE under MDR/IVDR — single market validity target: geo:cze · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No Türkiye CE under aligned MDR/IVDR — customs union free circulation target: geo:cze · sourceApproval: Türkiye CE under aligned MDR/IVDR · edgeType: customs union free circulation · marketAccessStrength: direct with local obligations · regulatoryLayer: product marketing · localApplicationRequired: No · targetDecisionRetained: No | 2026-08-13 | |
| 🇩🇰 Denmark Danish Medicines Agency All country facts → | EU CE under MDR/IVDR — single market validity target: geo:dnk · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No Türkiye CE under aligned MDR/IVDR — customs union free circulation target: geo:dnk · sourceApproval: Türkiye CE under aligned MDR/IVDR · edgeType: customs union free circulation · marketAccessStrength: direct with local obligations · regulatoryLayer: product marketing · localApplicationRequired: No · targetDecisionRetained: No | 2026-08-13 | |
| 🇪🇺 European Union EU MDR All country facts → | Foreign authorization recognition boundary recognized: No · blockedSources: approval:ukca · reason: UKCA alone is not recognized in the EU, EEA, or Northern Ireland. · target: regime:eu mdr ivdr Medical Device Single Audit Program — qms audit reliance target: regime:eu mdr ivdr · sourceApproval: Medical Device Single Audit Program · edgeType: qms audit reliance · marketAccessStrength: evidence only · regulatoryLayer: qms audit · localApplicationRequired: Yes · targetDecisionRetained: Yes | 2026-08-13 | |
| 🇫🇮 Finland Fimea All country facts → | EU CE under MDR/IVDR — single market validity target: geo:fin · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No Türkiye CE under aligned MDR/IVDR — customs union free circulation target: geo:fin · sourceApproval: Türkiye CE under aligned MDR/IVDR · edgeType: customs union free circulation · marketAccessStrength: direct with local obligations · regulatoryLayer: product marketing · localApplicationRequired: No · targetDecisionRetained: No | 2026-08-13 | |
| 🇫🇷 France ANSM All country facts → | EU CE under MDR/IVDR — single market validity target: geo:fra · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No Türkiye CE under aligned MDR/IVDR — customs union free circulation target: geo:fra · sourceApproval: Türkiye CE under aligned MDR/IVDR · edgeType: customs union free circulation · marketAccessStrength: direct with local obligations · regulatoryLayer: product marketing · localApplicationRequired: No · targetDecisionRetained: No | 2026-08-13 | |
| 🇩🇪 Germany BfArM All country facts → | EU CE under MDR/IVDR — single market validity target: geo:deu · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No Türkiye CE under aligned MDR/IVDR — customs union free circulation target: geo:deu · sourceApproval: Türkiye CE under aligned MDR/IVDR · edgeType: customs union free circulation · marketAccessStrength: direct with local obligations · regulatoryLayer: product marketing · localApplicationRequired: No · targetDecisionRetained: No | 2026-08-13 | |
| 🇬🇭 Ghana FDA Ghana All country facts → | WHO Prequalification of IVDs — collaborative abridged registration target: geo:gha · sourceApproval: WHO Prequalification of IVDs · edgeType: collaborative abridged registration · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes · timeTargetDays: 90 · timeBasis: working days after access to all relevant information | 2026-08-13 | |
| 🇬🇷 Greece EOF All country facts → | EU CE under MDR/IVDR — single market validity target: geo:grc · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No Türkiye CE under aligned MDR/IVDR — customs union free circulation target: geo:grc · sourceApproval: Türkiye CE under aligned MDR/IVDR · edgeType: customs union free circulation · marketAccessStrength: direct with local obligations · regulatoryLayer: product marketing · localApplicationRequired: No · targetDecisionRetained: No | 2026-08-13 | |
| 🇭🇺 Hungary NNGYK All country facts → | EU CE under MDR/IVDR — single market validity target: geo:hun · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No Türkiye CE under aligned MDR/IVDR — customs union free circulation target: geo:hun · sourceApproval: Türkiye CE under aligned MDR/IVDR · edgeType: customs union free circulation · marketAccessStrength: direct with local obligations · regulatoryLayer: product marketing · localApplicationRequired: No · targetDecisionRetained: No | 2026-08-13 | |
| 🇮🇩 Indonesia Ministry of Health All country facts → | ASEAN Common Submission Dossier Template — harmonized dossier only target: geo:idn · sourceApproval: ASEAN Common Submission Dossier Template · edgeType: harmonized dossier only · marketAccessStrength: evidence only · regulatoryLayer: dossier format · localApplicationRequired: Yes · targetDecisionRetained: Yes | 2026-08-13 | |
| 🇮🇪 Ireland HPRA All country facts → | EU CE under MDR/IVDR — single market validity target: geo:irl · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No Türkiye CE under aligned MDR/IVDR — customs union free circulation target: geo:irl · sourceApproval: Türkiye CE under aligned MDR/IVDR · edgeType: customs union free circulation · marketAccessStrength: direct with local obligations · regulatoryLayer: product marketing · localApplicationRequired: No · targetDecisionRetained: No | 2026-08-13 | |
| 🇮🇱 Israel AMAR All country facts → | Medical Device Single Audit Program — qms audit reliance target: geo:isr · sourceApproval: Medical Device Single Audit Program · edgeType: qms audit reliance · marketAccessStrength: evidence only · regulatoryLayer: qms audit · localApplicationRequired: Yes · targetDecisionRetained: Yes Australia TGA/ARTG market authorization evidence — reference approval registration route target: geo:isr · sourceApproval: Australia TGA/ARTG market authorization evidence · edgeType: reference approval registration route · marketAccessStrength: facilitated or eligibility · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes EU CE under MDR/IVDR — reference approval registration route target: geo:isr · sourceApproval: EU CE under MDR/IVDR · edgeType: reference approval registration route · marketAccessStrength: facilitated or eligibility · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes Health Canada medical-device licence — reference approval registration route target: geo:isr · sourceApproval: Health Canada medical device licence · edgeType: reference approval registration route · marketAccessStrength: facilitated or eligibility · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes US FDA 510(k), De Novo, or PMA — reference approval registration route target: geo:isr · sourceApproval: US FDA 510(k), De Novo, or PMA · edgeType: reference approval registration route · marketAccessStrength: facilitated or eligibility · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes | 2026-08-13 | |
| 🇮🇹 Italy AIFA All country facts → | EU CE under MDR/IVDR — single market validity target: geo:ita · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No Türkiye CE under aligned MDR/IVDR — customs union free circulation target: geo:ita · sourceApproval: Türkiye CE under aligned MDR/IVDR · edgeType: customs union free circulation · marketAccessStrength: direct with local obligations · regulatoryLayer: product marketing · localApplicationRequired: No · targetDecisionRetained: No | 2026-08-13 | |
| 🇯🇵 Japan PMDA All country facts → | Medical Device Single Audit Program — qms audit reliance target: geo:jpn · sourceApproval: Medical Device Single Audit Program · edgeType: qms audit reliance · marketAccessStrength: evidence only · regulatoryLayer: qms audit · localApplicationRequired: Yes · targetDecisionRetained: Yes | 2026-08-13 | |
| 🇰🇿 Kazakhstan Committee for Medical and Pharmaceutical Control All country facts → | EAEU common medical-device registration — common registration scope target: geo:kaz · sourceApproval: EAEU common medical device registration · edgeType: common registration scope · marketAccessStrength: direct if target selected · regulatoryLayer: product marketing · localApplicationRequired: No · targetDecisionRetained: Yes | 2026-08-13 | |
| 🇰🇪 Kenya PPB All country facts → | Medical Device Single Audit Program — qms audit reliance target: geo:ken · sourceApproval: Medical Device Single Audit Program · edgeType: qms audit reliance · marketAccessStrength: evidence only · regulatoryLayer: qms audit · localApplicationRequired: Yes · targetDecisionRetained: Yes WHO Prequalification of IVDs — collaborative abridged registration target: geo:ken · sourceApproval: WHO Prequalification of IVDs · edgeType: collaborative abridged registration · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes · timeTargetDays: 90 · timeBasis: working days after access to all relevant information | 2026-08-13 | |
| 🇱🇮 Liechtenstein Office of Public Health All country facts → | EU CE under MDR/IVDR — single market validity target: geo:lie · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No | 2026-08-13 | |
| 🇱🇹 Lithuania VASPVT All country facts → | EU CE under MDR/IVDR — single market validity target: geo:ltu · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No Türkiye CE under aligned MDR/IVDR — customs union free circulation target: geo:ltu · sourceApproval: Türkiye CE under aligned MDR/IVDR · edgeType: customs union free circulation · marketAccessStrength: direct with local obligations · regulatoryLayer: product marketing · localApplicationRequired: No · targetDecisionRetained: No | 2026-08-13 | |
| 🇱🇺 Luxembourg Directorate of Health All country facts → | EU CE under MDR/IVDR — single market validity target: geo:lux · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No Türkiye CE under aligned MDR/IVDR — customs union free circulation target: geo:lux · sourceApproval: Türkiye CE under aligned MDR/IVDR · edgeType: customs union free circulation · marketAccessStrength: direct with local obligations · regulatoryLayer: product marketing · localApplicationRequired: No · targetDecisionRetained: No | 2026-08-13 | |
| 🇲🇾 Malaysia MDA All country facts → | ASEAN Common Submission Dossier Template — harmonized dossier only target: geo:mys · sourceApproval: ASEAN Common Submission Dossier Template · edgeType: harmonized dossier only · marketAccessStrength: evidence only · regulatoryLayer: dossier format · localApplicationRequired: Yes · targetDecisionRetained: Yes Medical Device Single Audit Program — qms audit reliance target: geo:mys · sourceApproval: Medical Device Single Audit Program · edgeType: qms audit reliance · marketAccessStrength: evidence only · regulatoryLayer: qms audit · localApplicationRequired: Yes · targetDecisionRetained: Yes Australia TGA/ARTG market authorization evidence — verification route target: geo:mys · sourceApproval: Australia TGA/ARTG market authorization evidence · edgeType: verification route · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes · validFromText: 2025 09 30 for Singapore and Thailand sources EU CE under MDR/IVDR — verification route target: geo:mys · sourceApproval: EU CE under MDR/IVDR · edgeType: verification route · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes · validFromText: 2025 09 30 for Singapore and Thailand sources Health Canada medical-device licence — verification route target: geo:mys · sourceApproval: Health Canada medical device licence · edgeType: verification route · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes · validFromText: 2025 09 30 for Singapore and Thailand sources Japan MHLW/PMDA Ninsho or Shonin — verification route target: geo:mys · sourceApproval: Japan MHLW/PMDA Ninsho or Shonin · edgeType: verification route · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes · validFromText: 2025 09 30 for Singapore and Thailand sources Singapore HSA product registration — verification route target: geo:mys · sourceApproval: Singapore HSA product registration · edgeType: verification route · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes · validFromText: 2025 09 30 for Singapore and Thailand sources Thailand FDA medical-device authorization — verification route target: geo:mys · sourceApproval: Thailand FDA medical device authorization · edgeType: verification route · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes · validFromText: 2025 09 30 for Singapore and Thailand sources Great Britain UKCA — verification route target: geo:mys · sourceApproval: Great Britain UKCA · edgeType: verification route · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes · validFromText: 2025 09 30 for Singapore and Thailand sources US FDA 510(k), De Novo, or PMA — verification route target: geo:mys · sourceApproval: US FDA 510(k), De Novo, or PMA · edgeType: verification route · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes · validFromText: 2025 09 30 for Singapore and Thailand sources WHO Prequalification of IVDs — collaborative abridged registration target: geo:mys · sourceApproval: WHO Prequalification of IVDs · edgeType: collaborative abridged registration · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes · timeTargetDays: 90 · timeBasis: working days after access to all relevant information | 2026-08-13 | |
| 🇲🇽 Mexico COFEPRIS All country facts → | Medical Device Single Audit Program — qms audit reliance target: geo:mex · sourceApproval: Medical Device Single Audit Program · edgeType: qms audit reliance · marketAccessStrength: evidence only · regulatoryLayer: qms audit · localApplicationRequired: Yes · targetDecisionRetained: Yes Health Canada medical-device licence — equivalence or abridged review target: geo:mex · sourceApproval: Health Canada medical device licence · edgeType: equivalence or abridged review · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes Japan MHLW/PMDA Ninsho or Shonin — equivalence or abridged review target: geo:mex · sourceApproval: Japan MHLW/PMDA Ninsho or Shonin · edgeType: equivalence or abridged review · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes US FDA 510(k), De Novo, or PMA — equivalence or abridged review target: geo:mex · sourceApproval: US FDA 510(k), De Novo, or PMA · edgeType: equivalence or abridged review · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes | 2026-08-13 | |
| 🇲🇲 Myanmar FDA Myanmar All country facts → | ASEAN Common Submission Dossier Template — harmonized dossier only target: geo:mmr · sourceApproval: ASEAN Common Submission Dossier Template · edgeType: harmonized dossier only · marketAccessStrength: evidence only · regulatoryLayer: dossier format · localApplicationRequired: Yes · targetDecisionRetained: Yes | 2026-08-13 | |
| 🇳🇱 Netherlands CCMO All country facts → | EU CE under MDR/IVDR — single market validity target: geo:nld · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No Türkiye CE under aligned MDR/IVDR — customs union free circulation target: geo:nld · sourceApproval: Türkiye CE under aligned MDR/IVDR · edgeType: customs union free circulation · marketAccessStrength: direct with local obligations · regulatoryLayer: product marketing · localApplicationRequired: No · targetDecisionRetained: No | 2026-08-13 | |
| 🇳🇿 New Zealand Medsafe All country facts → | No foreign product approval held — notification without premarket approval target: geo:nzl · sourceApproval: No foreign product approval held · edgeType: notification without premarket approval · marketAccessStrength: direct with notification · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: No | 2026-08-13 | |
| 🇳🇬 Nigeria NAFDAC All country facts → | WHO Prequalification of IVDs — collaborative abridged registration target: geo:nga · sourceApproval: WHO Prequalification of IVDs · edgeType: collaborative abridged registration · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes · timeTargetDays: 90 · timeBasis: working days after access to all relevant information | 2026-08-13 | |
| 🇳🇴 Norway Norwegian Medical Products Agency All country facts → | EU CE under MDR/IVDR — single market validity target: geo:nor · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No | 2026-08-13 | |
| 🇴🇲 Oman Ministry of Health All country facts → | WHO Prequalification of IVDs — collaborative abridged registration target: geo:omn · sourceApproval: WHO Prequalification of IVDs · edgeType: collaborative abridged registration · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes · timeTargetDays: 90 · timeBasis: working days after access to all relevant information | 2026-08-13 | |
| 🇵🇭 Philippines FDA Philippines All country facts → | ASEAN Common Submission Dossier Template — harmonized dossier only target: geo:phl · sourceApproval: ASEAN Common Submission Dossier Template · edgeType: harmonized dossier only · marketAccessStrength: evidence only · regulatoryLayer: dossier format · localApplicationRequired: Yes · targetDecisionRetained: Yes Country-of-origin clearance or free-sale certificate — eligibility gate target: geo:phl · sourceApproval: Country of origin clearance or free sale certificate · edgeType: eligibility gate · marketAccessStrength: eligibility only · regulatoryLayer: filing prerequisite · localApplicationRequired: Yes · targetDecisionRetained: Yes WHO Prequalification of IVDs — collaborative abridged registration target: geo:phl · sourceApproval: WHO Prequalification of IVDs · edgeType: collaborative abridged registration · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes · timeTargetDays: 90 · timeBasis: working days after access to all relevant information | 2026-08-13 | |
| 🇵🇱 Poland URPL All country facts → | EU CE under MDR/IVDR — single market validity target: geo:pol · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No Türkiye CE under aligned MDR/IVDR — customs union free circulation target: geo:pol · sourceApproval: Türkiye CE under aligned MDR/IVDR · edgeType: customs union free circulation · marketAccessStrength: direct with local obligations · regulatoryLayer: product marketing · localApplicationRequired: No · targetDecisionRetained: No | 2026-08-13 | |
| 🇵🇹 Portugal INFARMED All country facts → | EU CE under MDR/IVDR — single market validity target: geo:prt · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No Türkiye CE under aligned MDR/IVDR — customs union free circulation target: geo:prt · sourceApproval: Türkiye CE under aligned MDR/IVDR · edgeType: customs union free circulation · marketAccessStrength: direct with local obligations · regulatoryLayer: product marketing · localApplicationRequired: No · targetDecisionRetained: No | 2026-08-13 | |
| 🇷🇴 Romania ANMDMR All country facts → | EU CE under MDR/IVDR — single market validity target: geo:rou · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No Türkiye CE under aligned MDR/IVDR — customs union free circulation target: geo:rou · sourceApproval: Türkiye CE under aligned MDR/IVDR · edgeType: customs union free circulation · marketAccessStrength: direct with local obligations · regulatoryLayer: product marketing · localApplicationRequired: No · targetDecisionRetained: No | 2026-08-13 | |
| 🇷🇺 Russia Roszdravnadzor All country facts → | EAEU common medical-device registration — common registration scope target: geo:rus · sourceApproval: EAEU common medical device registration · edgeType: common registration scope · marketAccessStrength: direct if target selected · regulatoryLayer: product marketing · localApplicationRequired: No · targetDecisionRetained: Yes | 2026-08-13 | |
| 🇸🇬 Singapore HSA All country facts → | ASEAN Common Submission Dossier Template — harmonized dossier only target: geo:sgp · sourceApproval: ASEAN Common Submission Dossier Template · edgeType: harmonized dossier only · marketAccessStrength: evidence only · regulatoryLayer: dossier format · localApplicationRequired: Yes · targetDecisionRetained: Yes Medical Device Single Audit Program — qms audit reliance target: geo:sgp · sourceApproval: Medical Device Single Audit Program · edgeType: qms audit reliance · marketAccessStrength: evidence only · regulatoryLayer: qms audit · localApplicationRequired: Yes · targetDecisionRetained: Yes Australia TGA/ARTG market authorization evidence — abridged review target: geo:sgp · sourceApproval: Australia TGA/ARTG market authorization evidence · edgeType: abridged review · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes EU CE under MDR/IVDR — abridged review target: geo:sgp · sourceApproval: EU CE under MDR/IVDR · edgeType: abridged review · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes Health Canada medical-device licence — abridged review target: geo:sgp · sourceApproval: Health Canada medical device licence · edgeType: abridged review · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes Japan MHLW/PMDA Ninsho or Shonin — abridged review target: geo:sgp · sourceApproval: Japan MHLW/PMDA Ninsho or Shonin · edgeType: abridged review · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes US FDA 510(k), De Novo, or PMA — abridged review target: geo:sgp · sourceApproval: US FDA 510(k), De Novo, or PMA · edgeType: abridged review · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes | 2026-08-13 | |
| 🇸🇰 Slovakia ŠÚKL All country facts → | EU CE under MDR/IVDR — single market validity target: geo:svk · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No Türkiye CE under aligned MDR/IVDR — customs union free circulation target: geo:svk · sourceApproval: Türkiye CE under aligned MDR/IVDR · edgeType: customs union free circulation · marketAccessStrength: direct with local obligations · regulatoryLayer: product marketing · localApplicationRequired: No · targetDecisionRetained: No | 2026-08-13 | |
| 🇸🇮 Slovenia JAZMP All country facts → | EU CE under MDR/IVDR — single market validity target: geo:svn · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No Türkiye CE under aligned MDR/IVDR — customs union free circulation target: geo:svn · sourceApproval: Türkiye CE under aligned MDR/IVDR · edgeType: customs union free circulation · marketAccessStrength: direct with local obligations · regulatoryLayer: product marketing · localApplicationRequired: No · targetDecisionRetained: No | 2026-08-13 | |
| 🇿🇦 South Africa SAHPRA All country facts → | Medical Device Single Audit Program — qms audit reliance target: geo:zaf · sourceApproval: Medical Device Single Audit Program · edgeType: qms audit reliance · marketAccessStrength: evidence only · regulatoryLayer: qms audit · localApplicationRequired: Yes · targetDecisionRetained: Yes WHO Prequalification of IVDs — collaborative abridged registration target: geo:zaf · sourceApproval: WHO Prequalification of IVDs · edgeType: collaborative abridged registration · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes · timeTargetDays: 90 · timeBasis: working days after access to all relevant information | 2026-08-13 | |
| 🇰🇷 South Korea MFDS All country facts → | Medical Device Single Audit Program — qms audit reliance target: geo:kor · sourceApproval: Medical Device Single Audit Program · edgeType: qms audit reliance · marketAccessStrength: evidence only · regulatoryLayer: qms audit · localApplicationRequired: Yes · targetDecisionRetained: Yes | 2026-08-13 | |
| 🇪🇸 Spain AEMPS All country facts → | EU CE under MDR/IVDR — single market validity target: geo:esp · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No Türkiye CE under aligned MDR/IVDR — customs union free circulation target: geo:esp · sourceApproval: Türkiye CE under aligned MDR/IVDR · edgeType: customs union free circulation · marketAccessStrength: direct with local obligations · regulatoryLayer: product marketing · localApplicationRequired: No · targetDecisionRetained: No | 2026-08-13 | |
| 🇱🇰 Sri Lanka NMRA All country facts → | WHO Prequalification of IVDs — collaborative abridged registration target: geo:lka · sourceApproval: WHO Prequalification of IVDs · edgeType: collaborative abridged registration · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes · timeTargetDays: 90 · timeBasis: working days after access to all relevant information | 2026-08-13 | |
| 🇸🇪 Sweden Swedish Medical Products Agency All country facts → | EU CE under MDR/IVDR — single market validity target: geo:swe · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No Türkiye CE under aligned MDR/IVDR — customs union free circulation target: geo:swe · sourceApproval: Türkiye CE under aligned MDR/IVDR · edgeType: customs union free circulation · marketAccessStrength: direct with local obligations · regulatoryLayer: product marketing · localApplicationRequired: No · targetDecisionRetained: No | 2026-08-13 | |
| 🇨🇭 Switzerland Swissmedic All country facts → | EU CE under MDR/IVDR — unilateral recognition target: geo:che · sourceApproval: EU CE under MDR/IVDR · edgeType: unilateral recognition · marketAccessStrength: direct with local obligations · regulatoryLayer: product marketing · localApplicationRequired: No · targetDecisionRetained: No | 2026-08-13 | |
| 🇹🇼 Taiwan TFDA All country facts → | Medical Device Single Audit Program — qms audit reliance target: geo:twn · sourceApproval: Medical Device Single Audit Program · edgeType: qms audit reliance · marketAccessStrength: evidence only · regulatoryLayer: qms audit · localApplicationRequired: Yes · targetDecisionRetained: Yes | 2026-08-13 | |
| 🇹🇿 Tanzania TMDA All country facts → | WHO Prequalification of IVDs — collaborative abridged registration target: regmarket:tza:mainland · sourceApproval: WHO Prequalification of IVDs · edgeType: collaborative abridged registration · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes · timeTargetDays: 90 · timeBasis: working days after access to all relevant information WHO Prequalification of IVDs — collaborative abridged registration target: regmarket:tza:zanzibar · sourceApproval: WHO Prequalification of IVDs · edgeType: collaborative abridged registration · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes · timeTargetDays: 90 · timeBasis: working days after access to all relevant information | 2026-08-13 | |
| 🇹🇭 Thailand Thai FDA All country facts → | ASEAN Common Submission Dossier Template — harmonized dossier only target: geo:tha · sourceApproval: ASEAN Common Submission Dossier Template · edgeType: harmonized dossier only · marketAccessStrength: evidence only · regulatoryLayer: dossier format · localApplicationRequired: Yes · targetDecisionRetained: Yes Australia TGA/ARTG market authorization evidence — abridged review target: geo:tha · sourceApproval: Australia TGA/ARTG market authorization evidence · edgeType: abridged review · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes · marketingHistoryMonths: 12 EU CE under MDR/IVDR — abridged review target: geo:tha · sourceApproval: EU CE under MDR/IVDR · edgeType: abridged review · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes · marketingHistoryMonths: 12 Health Canada medical-device licence — abridged review target: geo:tha · sourceApproval: Health Canada medical device licence · edgeType: abridged review · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes · marketingHistoryMonths: 12 Japan MHLW/PMDA Ninsho or Shonin — abridged review target: geo:tha · sourceApproval: Japan MHLW/PMDA Ninsho or Shonin · edgeType: abridged review · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes · marketingHistoryMonths: 12 US FDA 510(k), De Novo, or PMA — abridged review target: geo:tha · sourceApproval: US FDA 510(k), De Novo, or PMA · edgeType: abridged review · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes · marketingHistoryMonths: 12 Singapore HSA product registration — assessment report reliance target: geo:tha · sourceApproval: Singapore HSA product registration · edgeType: assessment report reliance · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes WHO Prequalification of IVDs — collaborative abridged registration target: geo:tha · sourceApproval: WHO Prequalification of IVDs · edgeType: collaborative abridged registration · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: Yes · timeTargetDays: 90 · timeBasis: working days after access to all relevant information | 2026-08-13 | |
| 🇹🇷 Turkey TITCK All country facts → | EU CE under MDR/IVDR — customs union free circulation target: geo:tur · sourceApproval: EU CE under MDR/IVDR · edgeType: customs union free circulation · marketAccessStrength: direct with local obligations · regulatoryLayer: product marketing · localApplicationRequired: No · targetDecisionRetained: No | 2026-08-13 | |
| 🇦🇪 United Arab Emirates EDE All country facts → | Country-of-origin or UAE-reference marketing-status evidence — eligibility gate target: geo:are · sourceApproval: Country of origin or UAE reference marketing status evidence · edgeType: eligibility gate · marketAccessStrength: eligibility only · regulatoryLayer: filing prerequisite · localApplicationRequired: Yes · targetDecisionRetained: Yes | 2026-08-13 | |
| 🇬🇧 United Kingdom MHRA All country facts → | Foreign authorization recognition boundary recognized: No · blockedSources: approval:ukca · reason: UKCA alone is not recognized in the EU, EEA, or Northern Ireland. · target: regmarket:gbr:northern ireland Legacy EU CE under MDD/AIMDD/IVDD — unilateral recognition target: regmarket:gbr:great britain · sourceApproval: Legacy EU CE under MDD/AIMDD/IVDD · edgeType: unilateral recognition · marketAccessStrength: direct with local registration · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: No · validToText: 2028 06 30 or 2030 06 30 depending on CE route and device EU CE under MDR/IVDR — unilateral recognition target: regmarket:gbr:great britain · sourceApproval: EU CE under MDR/IVDR · edgeType: unilateral recognition · marketAccessStrength: direct with local registration · regulatoryLayer: product marketing · localApplicationRequired: Yes · targetDecisionRetained: No · validToText: 2028 06 30 or 2030 06 30 depending on CE route and device EU CE under MDR/IVDR — single market validity target: regmarket:gbr:northern ireland · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct with local obligations · regulatoryLayer: product marketing · sameDeviceRequired: Yes · localApplicationRequired: No · targetDecisionRetained: No Medical Device Single Audit Program — qms audit reliance target: geo:gbr · sourceApproval: Medical Device Single Audit Program · edgeType: qms audit reliance · marketAccessStrength: evidence only · regulatoryLayer: qms audit · localApplicationRequired: Yes · targetDecisionRetained: Yes | 2026-08-13 | |
| 🇺🇸 United States FDA All country facts → | Foreign authorization recognition boundary recognized: No · blockedSources: registration:us fda establishment or listing · reason: Registration and listing are not product approval, clearance, or authorization. · target: geo:usa Foreign authorization recognition boundary recognized: No · blockedSources: approval:eu ce mdr ivdr; approval:health canada; approval:japan mhlw pmda; approval:au tga; approval:china nmpa; approval:ukca · reason: FDA states that it does not recognize foreign regulatory authorizations; the device must meet the applicable US pathway. · target: geo:usa Medical Device Single Audit Program — qms audit reliance target: geo:usa · sourceApproval: Medical Device Single Audit Program · edgeType: qms audit reliance · marketAccessStrength: evidence only · regulatoryLayer: qms audit · localApplicationRequired: Yes · targetDecisionRetained: Yes | 2026-08-13 | |
| 🇻🇳 Vietnam Ministry of Health All country facts → | ASEAN Common Submission Dossier Template — harmonized dossier only target: geo:vnm · sourceApproval: ASEAN Common Submission Dossier Template · edgeType: harmonized dossier only · marketAccessStrength: evidence only · regulatoryLayer: dossier format · localApplicationRequired: Yes · targetDecisionRetained: Yes | 2026-08-13 |
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