Medical Device Registration Timeline
Compare official vs realistic approval timelines across 29 countries. See how prior approvals from FDA, EU MDR, and others can accelerate your global market entry.
How Long Does Medical Device Registration Take?
Medical device registration timelines vary dramatically by country and device class. An FDA 510(k) clearance officially takes 90 days but realistically requires 6-12 months. EU MDR Class III devices average 24-36 months due to Notified Body capacity constraints. Meanwhile, Singapore's IBR pathway with prior FDA and EU approval enables registration in under 1 hour—the fastest in the world.
This interactive tool compares official timelines (regulatory agency targets), realistic timelines (industry averages including preparation and delays), and accelerated timelines achievable with strategic prior approvals and MDSAP certification. One MDSAP audit can replace 5 separate regulatory audits, covering USA, Canada, Brazil, Japan, and Australia.
90 days
FDA 510(k) Official
6-12 mo
FDA 510(k) Realistic
<1 hour
Singapore IBR
29
Countries Covered
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Showing 29 of 29 countries
CountriesAll
Risk LevelAll
| 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 | 1.3-2.7 years | 8-16 months | FDA 510(k), Health Canada, Japan PMDA | |
| Class III(Registration or Equivalency) | 6-12 months | 1.3-2.7 years | 8-16 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 |
Key Insights from Our 29-Country Analysis
Fastest Market Entry
Singapore IBR with FDA + EU approval enables registration in under 1 hour—the fastest pathway globally. For Class I devices without prior approvals, Australia TGA and Singapore HSA both offer ~1 week timelines.
Longest Timelines
China NMPA Class III devices require 24-48 months including mandatory in-country clinical trials. EU MDR Class III takes 18-36 months due to Notified Body capacity constraints that have doubled historical review times.
Best ROI: MDSAP Certification
One MDSAP audit can replace 5 separate regulatory audits, covering USA, Canada, Brazil, Japan, and Australia. It's mandatory for Canada Class II-IV and extends Brazil B-GMP validity to 4 years.
Optimal Global Strategy
Start with FDA 510(k) and EU MDR in parallel—these unlock expedited pathways in 15+ countries. Add MDSAP certification, then expand to Singapore, Mexico, and Brazil for fast secondary market entry.
Frequently Asked Questions
Common questions about medical device registration timelines worldwide
Timelines are estimates based on 2024-2025 data and may vary based on device complexity, submission quality, and regulatory workload. Last updated: December 2025.