Medical Device Government Fees 2026
Compare official registration fees across 31 countries. All amounts shown in local currency and converted to USD with live exchange rates.
31
Countries
$0-$118k
Fee Range
Live
Exchange Rates
Jan 2026
Data Updated
Filters
Showing 31 countries, 159 fee items
CountriesAll
Official government feesGovernment fees only — excludes consulting, testing and local representative costs
| Country | Fee Item | Local Currency | USD | Notes |
|---|---|---|---|---|
 Argentina | Annual Maintenance - Class I | ARS 39,500 | $38 | Annual per product |
| Annual Maintenance - Class II | ARS 52,000 | $49 | Annual per product | |
| Annual Maintenance - Class III | ARS 70,000 | $67 | Annual per product | |
| Annual Maintenance - Class IV | ARS 93,000 | $88 | Annual per product | |
| Transfer - Imported Product | ARS 587,700 | $558 | Per transfer | |
| Manufacturer/Importer Authorization | ARS 1,529,400 | $1,453 | One-time | |
| GMP Verification - Foreign (Main) | ARS 9,439,200 | $8,967 | Per facility | |
 Australia | Annual Fee - Class I (other) | AUD 114 | $74 | Annual per product |
| Annual Fee - Class I (measuring/sterile) | AUD 828 | $538 | Annual per product | |
| Annual Fee - Class IIa/IIb | AUD 1,230 | $800 | Annual per product | |
| Annual Fee - Class III/AIMD | AUD 1,566 | $1,018 | Annual per product | |
| Application Fee - Class I | AUD 621 | $404 | One-time per product | |
| Application Fee - Class IIa/IIb | AUD 1,187 | $772 | One-time per product | |
| Application Fee - Class III | AUD 1,530 | $995 | One-time per product | |
| IVD Annual Fee | AUD 893 | $580 | Annual per product | |
| IVD Application Fee | AUD 1,187 | $772 | One-time per product | |
 Bangladesh | Registration - Class A | Free | Free | Per registration · No government fees |
| Registration - Class B/C/D | BDT 63,250 | $519 | Per registration · Includes 15% VAT | |
| Renewal - Class B/C/D | BDT 11,500 | $94 | Every 5 years | |
 Brazil | Notification Fee (Class I/II) | BRL 1,406 | $239 | Per product |
| Registration Fee - Family (Class III/IV) | BRL 8,510 | $1,447 | Per product | |
| Registration Fee - Large Family (Class III/IV) | BRL 19,856 | $3,376 | Per product | |
| B-GMP Certification - International (Class III/IV) | BRL 72,805 | $12,377 | One-time per manufacturer · Required for Class III/IV | |
| B-GMP Certification - MERCOSUL (Class III/IV) | BRL 10,637 | $1,808 | One-time per manufacturer · For MERCOSUL countries only | |
| Procedural Review Fee | BRL 1,406 | $239 | If applicable | |
 Canada | MDL Application - Class II | CAD 643 | $476 | Per application |
| MDL Application - Class III | CAD 14,163 | $10,481 | Per application | |
| MDL Application - Class III (near patient) | CAD 30,169 | $22,325 | Per application | |
| MDL Application - Class IV | CAD 30,713 | $22,728 | Per application | |
| Establishment Licence (MDEL) | TBD | TBD | Annual · Class I only | |
| Annual Right to Sell | TBD | TBD | Annual · Class II/III/IV | |
 China | Initial Registration - Class II | CNY 210,900 | $29,526 | Per registration |
| Initial Registration - Class III | CNY 308,800 | $43,232 | Per registration | |
| Variation - Class II | CNY 42,000 | $5,880 | Per variation | |
| Variation - Class III | CNY 50,400 | $7,056 | Per variation | |
| Renewal - Class II/III | CNY 40,800 | $5,712 | Every 5 years | |
 Colombia | MD Application - Class I | COP 3,898,330 | $936 | Per product |
| MD Application - Class IIa | COP 3,898,330 | $936 | Per product | |
| MD Application - Class IIb | COP 4,412,400 | $1,059 | Per product | |
| MD Application - Class III | COP 4,412,400 | $1,059 | Per product | |
| IVD Application - Class I/II | COP 2,570,590 | $617 | Per product | |
| IVD Application - Class III | COP 3,427,327 | $823 | Per product | |
| Trademark Application | COP 1,288,000 - 1,714,500 | $309 | Per application · Range depending on type | |
 Costa Rica | MD Registration - Class I | Free | Free | Per registration |
| MD Registration - Class II | $25 | $25 | Per registration | |
| MD Registration - Class III | $50 | $50 | Per registration | |
| MD Registration - Class IV | $50 | $50 | Per registration | |
 Ecuador | MD/IVD Registration | $905 | $905 | Per registration · All classes |
| MD/IVD Renewal | $185 | $185 | Per renewal · All classes | |
 Egypt | Registration - Normal Track | EGP 10,005 | $200 | Per registration · MD & IVD all classes |
| Registration - Fast Track | EGP 20,005 | $400 | Per registration · MD only | |
| Bundling (2-25 files) | EGP 25,005 | $500 | Per bundle · IVD only | |
| Bundling (2-100 files) | EGP 55,000 | $1,100 | Per bundle · IVD only | |
| Manufacturer Addition | EGP 10,005 | $200 | Per manufacturer | |
| Major Variation - Fast Track | EGP 12,000 | $240 | Per variation | |
| Major Variation - Normal Track | EGP 6,000 | $120 | Per variation | |
| Minor Variation - Fast Track | EGP 4,000 | $80 | Per variation | |
| Minor Variation - Normal Track | EGP 2,000 | $40 | Per variation | |
 European Union | EUDAMED Registration | Free | Free | Per registration · No government fee |
 Hong Kong | Device Listing (Class II-IV) | Free | Free | Per listing · Voluntary system |
 India | Notification Fee - Class A | $1,000 | $1,000 | Per notification |
| Notification Fee - Class A (Family) | $50 | $50 | Per additional device | |
| Registration Fee - Class B | $2,000 | $2,000 | Per registration | |
| Registration Fee - Class B (Family) | $1,000 | $1,000 | Per additional device | |
| Registration Fee - Class C | $3,000 | $3,000 | Per registration | |
| Registration Fee - Class C (Family) | $1,500 | $1,500 | Per additional device | |
| Registration Fee - Class D | $3,000 | $3,000 | Per registration | |
| Registration Fee - Class D (Family) | $1,500 | $1,500 | Per additional device | |
 Indonesia | Registration - Class A | IDR 1,500,000 | $93 | Per product |
| Registration - Class B | IDR 3,000,000 | $186 | Per product | |
| Registration - Class C | IDR 3,000,000 | $186 | Per product | |
| Registration - Class D | IDR 5,000,000 | $310 | Per product | |
 Israel | Registration - Class I (all types) | Free | Free | Per registration · Class I fees waived |
| Registration - Class II/III | TBD | TBD | Per registration · Not publicly available | |
 Japan | Todokede - Class I (Notification) | Free | Free | Per product |
| Ninsho - Class II (Certification) | ¥500,000 | $3,350 | Per product · Third-party certification | |
| Shonin - Class II/III (Follow-on) | ¥1,879,900 | $12,595 | Per approval | |
| Shonin - Class IV (Follow-on) | ¥3,080,600 | $20,640 | Per approval | |
| Shonin - Class II/III (New, no clinical) | ¥11,816,400 | $79,170 | Per approval | |
| Shonin - Class IV (New, no clinical) | ¥16,520,700 | $110,689 | Per approval | |
| Shonin - Class II/III (New, clinical) | ¥13,016,900 | $87,213 | Per approval | |
| Shonin - Class IV (New, clinical) | ¥17,721,200 | $118,732 | Per approval | |
 Malaysia | Application Fee - Class A | MYR 500 | $110 | Per product |
| Application Fee - Class B | MYR 250 | $55 | Per product | |
| Application Fee - Class C | MYR 500 | $110 | Per product | |
| Application Fee - Class D | MYR 750 | $165 | Per product | |
| Registration Fee - Class A | MYR 750 | $165 | Per product | |
| Registration Fee - Class B | MYR 1,000 | $220 | Per product | |
| Registration Fee - Class C | MYR 2,000 | $440 | Per product | |
| Registration Fee - Class D | MYR 3,000 | $660 | Per product | |
 Mexico | New Registration - Class I & I Low Risk | MXN 16,499 | $825 | One-time per product |
| New Registration - Class II | MXN 24,198 | $1,210 | One-time per product | |
| New Registration - Class III | MXN 30,798 | $1,540 | One-time per product | |
| Renewal - Class I & I Low Risk | MXN 12,374 | $619 | Every 5 years | |
| Renewal - Class II | MXN 18,149 | $907 | Every 5 years | |
| Renewal - Class III | MXN 23,098 | $1,155 | Every 5 years | |
 Pakistan | Enlistment - Class A | PKR 6,300 | $23 | Per enlistment |
| Registration - Class B (Import) | PKR 32,400 | $117 | Per registration | |
| Registration - Class C/D (Import) | PKR 64,800 | $233 | Per registration | |
| Renewal - Class B (Import) | PKR 15,700 | $57 | Per renewal | |
| Renewal - Class C/D (Import) | PKR 32,400 | $117 | Per renewal | |
| System/Family Registration - Class C/D | PKR 104,500 | $376 | Per registration · For 20+ devices | |
 Peru | MD Registration - Class I | €400 | $432 | Per registration |
| MD Registration - Class II | €460 | $497 | Per registration | |
| MD Registration - Class III | €510 | $551 | Per registration | |
| MD Registration - Class IV | €580 | $626 | Per registration | |
| IVD Registration | €460 | $497 | Per registration · Estimated based on Class II | |
 Philippines | Registration - Class A | PHP 81,810 | $1,391 | Per registration · 6-year validity |
| Registration - Class B | PHP 109,080 | $1,854 | Per registration · 6-year validity | |
| Registration - Class C | PHP 112,110 | $1,906 | Per registration · 6-year validity | |
| Registration - Class D | PHP 118,170 | $2,009 | Per registration · 6-year validity | |
| Annual Registration | PHP 15,453 | $263 | Annual · All classes | |
 Saudi Arabia | Application Assessment - Class A | SAR 15,000 | $4,050 | Per application |
| Application Assessment - Class B | SAR 19,000 | $5,130 | Per application | |
| Application Assessment - Class C | SAR 21,000 | $5,670 | Per application | |
| Application Assessment - Class D | SAR 23,000 | $6,210 | Per application | |
| UDI Code Fee (<150 codes) | $15 | $15 | Per batch | |
| UDI Code Fee (<500 codes) | $18 | $18 | Per batch | |
 Singapore | Application Fee - All Classes | SGD 560 | $414 | Per product · Base fee for Class B/C/D |
| Evaluation - Abridged (Class B) | SGD 2,010 | $1,487 | Per product | |
| Evaluation - Abridged (Class C) | SGD 3,900 | $2,886 | Per product | |
| Evaluation - Full (Class D) | SGD 6,250 | $4,625 | Per product | |
 South Korea | Approval - Class 1 | KRW 85,000 | $60 | Per approval · Pre-market notification |
| Approval - Class 2 (with S.E.) | KRW 130,000 | $92 | Per approval · 35 days · Substantial equivalent | |
| Approval - Class 2 (without S.E.) | KRW 1,495,000 | $1,061 | Per approval · 80 days · Requires clinical data | |
| Approval - Class 3/4 (with S.E.) | KRW 719,000 | $510 | Per approval · 65 days · Substantial equivalent | |
| Approval - Class 3/4 (without S.E.) | KRW 1,495,000 | $1,061 | Per approval · 80 days · Requires clinical data | |
 Switzerland | MD/IVD Registration Fee | TBD | TBD | Per registration · Fee amount not yet confirmed by Swissmedic |
| Custom-made Device Notification | CHF 300 | $339 | Per device · Different registration route for custom-made devices | |
 Taiwan | Registration - Class I | TWD 15,000 | $465 | Per registration |
| Registration - Class II | TWD 58,000 | $1,798 | Per registration | |
| Registration - Class III | TWD 100,000 | $3,100 | Per registration | |
| Export Only | TWD 15,000 | $465 | Per product · All classes | |
| Breakthrough Product | TWD 250,000 | $7,750 | Per product · First-in-world products | |
| Priority Review (Expedited) | TWD 180,000 | $5,580 | Per registration | |
| Novel Product | TWD 130,000 | $4,030 | Per registration · New mechanism/structure/material | |
 Thailand | Application Fee - Class 1 | THB 500 | $15 | Per product |
| Approval Fee - Class 1 | THB 2,600 | $75 | Per product | |
| Application Fee - Class 2/3 | THB 1,000 | $29 | Per product | |
| Approval Fee - Class 2/3 | THB 10,000 | $290 | Per product | |
| Application Fee - Class 4 | THB 1,000 | $29 | Per product | |
| Approval Fee - Class 4 | THB 20,000 | $580 | Per product | |
| Expert Review - Class 2/3 | THB 38,000 | $1,102 | If required · Novel devices | |
| Expert Review - Class 4 | THB 53,000 | $1,537 | If required · Novel devices | |
 UAE | Application Fee | AED 100 | $27 | Per application |
| Device Registration | AED 5,000 | $1,350 | Per device | |
| Manufacturer Registration License | AED 10,000 | $2,700 | Per manufacturer | |
| Classification Service | AED 500 | $135 | Per request | |
 United Kingdom | Registration Fee (until March 2026) | £261 | $331 | Per application |
| New Estimated Fees Starting April 2026 | £300 | $381 | Annual per level 2 GMDN · Estimated fee - subject to confirmation | |
 USA | Annual Establishment Registration | $11,423 | $11,423 | Annual per facility |
| 510(k) Review - Standard | $26,067 | $26,067 | Per submission · Class II typically | |
| 510(k) Review - Small Business | $6,517 | $6,517 | Per submission · FDA-qualified small businesses | |
| De Novo Review - Standard | $173,782 | $173,782 | Per submission | |
| De Novo Review - Small Business | $43,446 | $43,446 | Per submission | |
 Vietnam | Application - Class A | VND 500,000 | $20 | Per product |
| Application - Class B | VND 1,500,000 | $60 | Per product | |
| Application - Class C | VND 3,000,000 | $120 | Per product | |
| Application - Class D | VND 3,000,000 | $120 | Per product |
Government fees are subject to change. Exchange rates are updated daily. Always verify current fees with the regulatory authority. Last data update: January 2026. Methodology
Need a launch-sequence plan? Talk to an expert →How Much Does Medical Device Registration Cost?
Medical device registration fees vary dramatically by country - from free in Costa Rica and Hong Kong to over $100,000 in Japan for high-risk devices. FDA 510(k) fees are $26,067 (or $6,517 for small businesses), while NMPA China charges ¥210,900-¥308,800 (~$29,000-$43,000 USD). The EU has no government registration fees (EUDAMED is free), but Notified Body fees add €4,000-€50,000+. Most affordable markets include UK MHRA (£261), Malaysia (MYR 500-3,750), and Peru (€400-€580). This table shows government fees only - actual costs include consulting, testing, and local representative fees. Powered by Pure Global, regulatory experts in 50+ countries.
Frequently Asked Questions
Common questions about medical device registration fees worldwide