Medical Device Registration Timeline
Compare official vs realistic timelines across 29 countries. See how prior approvals can accelerate your registration.
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Showing 29 of 29 countries
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| Country | Class | Official | Realistic | Speedup | With Prior Approval From |
|---|---|---|---|---|---|
| 🇺🇸 United States | 510(k)(Premarket Notification) | 3 months | 6-12 months | 6-8 months | Prior 510(k) as predicate, Pre-Sub meeting |
| De Novo(De Novo Classification) | 5 months | 8-15 months | - | - | |
| PMA(Premarket Approval) | 6 months | 4-8 years | 4-6 years | Breakthrough Device Designation | |
| 🇪🇺 European Union | Class I(Self-certification) | 3-6 months | 6-9 months | - | - |
| Class IIa(Notified Body certification) | 8-12 months | 1.1-1.5 years | - | - | |
| Class IIb(Notified Body certification) | 1-1.5 years | 1.3-2 years | - | - | |
| Class III(Full Notified Body review) | 1.5-2 years | 2-3 years | - | - | |
| 🇨🇳 China | Class I(Filing/Recordation) | 1 week | 2-4 months | - | - |
| Class II(Provincial Registration) | 4 months | 1-1.5 years | - | - | |
| Class III(NMPA Registration) | 5-6 months | 2-3 years | 1.2-1.7 years | Priority review for innovative devices, Hainan pilot | |
| 🇯🇵 Japan | Class I(Notification (Todokede)) | 1 week | 2-3 weeks | - | - |
| Class II(Certification (Ninsho) or Approval (Shonin)) | 3-9 months | 5-12 months | 4-7 months | MDSAP certification | |
| Class III(Approval (Shonin)) | 9-12 months | 1-1.5 years | 1-1.5 years | MDSAP, Foreign clinical data (if GCP compliant) | |
| Class IV(Approval (Shonin)) | 1-1.2 years | 1.5-2 years | 1-2 years | SAKIGAKE designation, MDSAP | |
| 🇧🇷 Brazil | Class I(Notification) | 1-2 months | 2-3 months | - | - |
| Class II(Notification) | 1-2 months | 2-15 months | - | - | |
| Class III(Registration) | 4-12 months | 1.5-2 years | 8-12 months | FDA 510(k)/PMA (via IN 290/2024), MDSAP for B-GMP | |
| Class IV(Registration) | 8-15 months | 2-3 years | 10-14 months | FDA 510(k)/PMA (via IN 290/2024), MDSAP for B-GMP | |
| 🇨🇦 Canada | Class I(MDEL Only (no device license)) | 4 months | 2-3 months | - | - |
| Class II(Device License) | 2 weeks | 1-1.5 months | - | - | |
| Class III(Device License with clinical data) | 2.5 months | 3-4 months | - | - | |
| Class IV(Device License) | 3 months | 4-5 months | - | - | |
| 🇦🇺 Australia | Class I(Notification) | 0-1 weeks | 0.5-1 months | - | - |
| Class IIa(Conformity Assessment) | 1 month | 1-1.5 months | 0.8-1 months | EU CE Mark, FDA 510(k), MDSAP | |
| Class IIb(Enhanced Assessment) | 1.5 months | 1.5-2 months | 1-1.5 months | EU CE Mark, FDA 510(k), MDSAP | |
| Class III(Full Assessment) | 5-7.5 months | 6-9 months | 3-5 months | EU CE Mark (30-50% faster), FDA 510(k), MDSAP | |
| 🇬🇧 United Kingdom | Class I(Self-declaration or CE Mark) | 0.5-1 months | 0.5-1 months | 2-3 weeks | EU CE Mark (accepted until 2028+) |
| Class IIa(UKCA (UK Approved Body) or CE Mark) | 3-6 months | 3-6 months | 0.5-1 months | EU CE Mark (accepted until Jun 2028) | |
| Class IIb(UKCA (UK Approved Body) or CE Mark) | 4-8 months | 4-8 months | 0.5-1 months | EU CE Mark (accepted until Jun 2028 or Dec 2027 for implantables) | |
| Class III(UKCA (UK Approved Body) or CE Mark) | 6-12 months | 6-12 months | 0.5-1 months | EU CE Mark (accepted until Dec 2027 for Class III) | |
| 🇰🇷 South Korea | Class I(Self-declaration) | 1-2 weeks | 1-2 weeks | - | - |
| Class II(MFDS Review) | 2-4 months | 3-6 months | 2-4 months | MDSAP for K-GMP | |
| Class III(MFDS Review with clinical data) | 4-8 months | 6-12 months | - | - | |
| Class IV(MFDS Review with extensive clinical) | 8-12 months | 10-15 months | - | - | |
| 🇮🇳 India | Class A(Registration) | 3-6 months | 6-9 months | 3-5 months | GHTF country approval (FDA, EU, Japan, Australia, UK) |
| Class B(Registration) | 4-8 months | 8-12 months | 4-7 months | GHTF country approval | |
| Class C(Registration with clinical data) | 6-12 months | 1-1.5 years | 6-9 months | GHTF country approval with predicate | |
| Class D(Registration with extensive clinical) | 8-15 months | 1.3-2 years | 8-12 months | GHTF country approval | |
| 🇲🇽 Mexico | Class I(Registration) | 1-3 months | 2-4 months | - | - |
| Class II(Registration or Equivalency) | 4-8 months | 4-12 months | 2-5 months | FDA 510(k), Health Canada, Japan PMDA | |
| Class III(Registration or Equivalency) | 6-12 months | 8-15 months | 3-6 months | FDA 510(k)/PMA, Health Canada, Japan PMDA | |
| 🇸🇦 Saudi Arabia | Class A(MDNR Listing) | 1 week | 1-2 weeks | - | - |
| Class B(MDMA Registration) | 1-2 months | 1.5-3 months | - | - | |
| Class C(MDMA Registration) | 2-4 months | 3-5 months | - | - | |
| Class D(MDMA Registration) | 3-5 months | 4-6 months | - | - | |
| 🇸🇬 Singapore | Class A(Notification) | 1 week | 1-2 weeks | - | - |
| Class B(IBR/Expedited/Full Route) | 1-5 months | 2-6 months | 0-2 weeks | FDA + EU (IBR = instant), FDA or EU (Expedited) | |
| Class C(IBR/Expedited/Full Route) | 3-8 months | 4-10 months | 0-3 months | FDA + EU (IBR = instant), FDA or EU (Expedited) | |
| Class D(IBR/Expedited/Full Route) | 5-11 months | 6-12 months | 0-5 months | FDA + EU (IBR = instant), FDA or EU (Expedited) | |
| 🇹🇼 Taiwan | Class I(Registration) | 1-3 months | 3-7 months | - | - |
| Class II(Registration) | 6-10 months | 9-14 months | 6-9 months | FDA 510(k), EU CE Mark, Japan PMDA | |
| Class III(Registration with clinical data) | 8-12 months | 1-1.5 years | 8-11 months | FDA 510(k)/PMA, EU CE Mark, Japan PMDA | |
| 🇦🇷 Argentina | Class I(Registration) | 2-4 months | 4-6 months | - | - |
| Class II(Registration) | 4-8 months | 6-12 months | 4-7 months | FDA 510(k), EU CE Mark | |
| Class III(Registration with clinical data) | 8-12 months | 1-1.5 years | 8-12 months | FDA 510(k)/PMA, EU CE Mark | |
| Class IV(Full Registration) | 1-1.5 years | 1.5-2 years | 1-1.3 years | FDA PMA, EU CE Mark Class III | |
| 🇨🇴 Colombia | Class I(Notification (NSO)) | 0.5-1 months | 1-2 months | - | - |
| Class IIa(Registration (NSO)) | 2-4 months | 3-6 months | 2-3 months | FDA 510(k), EU CE Mark, Health Canada | |
| Class IIb(Registration (RSO)) | 4-8 months | 6-12 months | 4-6 months | FDA 510(k), EU CE Mark, Health Canada | |
| Class III(Full Registration (RSO)) | 6-12 months | 9-18 months | 6-10 months | FDA PMA, EU CE Mark Class III, Health Canada | |
| 🇵🇪 Peru | Class I(Notification) | 1-2 months | 2-4 months | - | - |
| Class II(Registration) | 3-6 months | 4-8 months | 3-5 months | FDA 510(k), EU CE Mark, ANVISA | |
| Class III(Registration) | 4-8 months | 6-12 months | 4-7 months | FDA 510(k)/PMA, EU CE Mark, ANVISA | |
| Class IV(Full Registration) | 6-10 months | 8-15 months | 5-8 months | FDA PMA, EU CE Mark Class III | |
| 🇨🇭 Switzerland | Class I(Self-certification) | 2-4 months | 3-5 months | 1-2 months | EU CE Mark (full recognition until 2028) |
| Class IIa(Conformity Assessment) | 4-8 months | 6-10 months | 0.5-2 months | EU CE Mark (immediate access) | |
| Class IIb(Enhanced Conformity Assessment) | 6-12 months | 8-14 months | 0.5-2 months | EU CE Mark (immediate access) | |
| Class III(Full Assessment) | 10-18 months | 1-2 years | 0.5-2 months | EU CE Mark (immediate access) | |
| 🇮🇱 Israel | Class A(Registration) | 1-2 months | 2-4 months | 1-2 months | FDA, EU CE Mark |
| Class B(Registration) | 2-4 months | 3-6 months | 2-3 months | FDA 510(k), EU CE Mark | |
| Class C(Registration with clinical data) | 4-8 months | 6-12 months | 3-6 months | FDA 510(k), EU CE Mark | |
| Class D(Full Registration) | 6-12 months | 9-18 months | 5-10 months | FDA PMA, EU CE Mark Class III | |
| 🇦🇪 United Arab Emirates | Class A(Registration) | 1-2 months | 2-3 months | 1-2 months | FDA, EU CE Mark, Health Canada, Australia TGA |
| Class B(Registration) | 2-4 months | 3-6 months | 2-3 months | FDA 510(k), EU CE Mark, Health Canada | |
| Class C(Registration) | 3-6 months | 4-8 months | 3-5 months | FDA 510(k), EU CE Mark, Health Canada, Australia TGA | |
| Class D(Full Registration) | 4-8 months | 6-12 months | 4-7 months | FDA PMA, EU CE Mark Class III | |
| 🇪🇬 Egypt | Class A(Notification) | 1-3 months | 2-4 months | - | - |
| Class B(Registration) | 3-6 months | 4-9 months | 3-5 months | FDA, EU CE Mark | |
| Class C(Registration) | 4-8 months | 6-12 months | 4-7 months | FDA 510(k), EU CE Mark | |
| Class D(Full Registration) | 6-12 months | 9-18 months | 6-10 months | FDA PMA, EU CE Mark Class III | |
| 🇮🇩 Indonesia | Class A(Notification) | 1-2 months | 2-4 months | - | - |
| Class B(Registration) | 3-6 months | 4-9 months | 3-5 months | ASEAN MRA countries, FDA, EU CE Mark | |
| Class C(Full Registration) | 6-12 months | 9-18 months | 6-10 months | ASEAN MRA countries, FDA, EU CE Mark | |
| 🇲🇾 Malaysia | Class A(Notification) | 0.5-1 months | 1-2 months | - | - |
| Class B(Registration) | 2-4 months | 3-6 months | 2-4 months | FDA, EU CE Mark, ASEAN MRA | |
| Class C(Registration) | 3-6 months | 4-8 months | 3-5 months | FDA, EU CE Mark, ASEAN MRA | |
| Class D(Full Registration) | 4-8 months | 6-12 months | 4-7 months | FDA PMA, EU CE Mark Class III | |
| 🇹🇭 Thailand | Class 1(Notification) | 1-2 months | 2-4 months | - | - |
| Class 2(Registration) | 3-6 months | 4-9 months | 3-5 months | FDA, EU CE Mark, ASEAN MRA | |
| Class 3(Registration) | 4-8 months | 6-12 months | 4-7 months | FDA, EU CE Mark, ASEAN MRA | |
| Class 4(Full Registration) | 6-12 months | 9-18 months | 6-10 months | FDA PMA, EU CE Mark Class III | |
| 🇻🇳 Vietnam | Class A(Declaration) | 0.5-1 months | 1-2 months | - | - |
| Class B(Registration) | 2-4 months | 3-6 months | 2-4 months | FDA, EU CE Mark, ASEAN MRA | |
| Class C(Registration) | 3-6 months | 4-9 months | 3-5 months | FDA, EU CE Mark, ASEAN MRA | |
| Class D(Full Registration) | 4-8 months | 6-12 months | 4-7 months | FDA PMA, EU CE Mark Class III | |
| 🇵🇭 Philippines | Class A(Notification) | 1-2 months | 2-4 months | - | - |
| Class B(Registration) | 3-6 months | 4-9 months | 3-5 months | FDA, EU CE Mark, ASEAN MRA | |
| Class C(Registration) | 4-8 months | 6-12 months | 4-7 months | FDA, EU CE Mark, ASEAN MRA | |
| Class D(Full Registration) | 6-12 months | 9-18 months | 6-10 months | FDA PMA, EU CE Mark Class III | |
| 🇭🇰 Hong Kong | Class I(Listing) | 1-2 weeks | 0.5-1 months | - | - |
| Class II(Listing) | 1-2 months | 1-3 months | 0.5-1 months | FDA, EU CE Mark, Health Canada, Australia TGA, Japan PMDA | |
| Class III(Listing) | 2-4 months | 2-5 months | 1-3 months | FDA, EU CE Mark, Health Canada, Australia TGA, Japan PMDA | |
| Class IV(Listing) | 3-6 months | 3-6 months | 2-4 months | FDA PMA, EU CE Mark Class III | |
| 🇵🇰 Pakistan | Class A(Notification) | 1-3 months | 2-4 months | - | - |
| Class B(Registration) | 3-6 months | 4-9 months | 3-5 months | FDA, EU CE Mark | |
| Class C(Registration) | 4-8 months | 6-12 months | 4-7 months | FDA, EU CE Mark | |
| Class D(Full Registration) | 6-12 months | 9-18 months | 6-10 months | FDA PMA, EU CE Mark Class III | |
| 🇧🇩 Bangladesh | Class A(Notification) | 1-3 months | 2-5 months | - | - |
| Class B(Registration) | 3-6 months | 4-9 months | 3-6 months | FDA, EU CE Mark | |
| Class C(Registration) | 4-8 months | 6-12 months | 4-8 months | FDA, EU CE Mark | |
| Class D(Full Registration) | 6-12 months | 9-18 months | 6-12 months | FDA PMA, EU CE Mark Class III |
Frequently Asked Questions
Timelines are estimates based on 2024-2025 data and may vary based on device complexity, submission quality, and regulatory workload. Last updated: December 2025.