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Registration planning benchmark
Medical Device Registration Timelines and Fees, by Country
A 34-country planning matrix comparing standard medical-device review timelines, certificate validity, official fee models, and representative government charges. Blank cells mean the country page does not yet state the fact in Element 3 or Element 5.
The direct answer
There is no single global answer for registration time or cost, but there is a clear pattern: low-risk notifications take days to weeks, while a full high-risk review takes 9 months to 2 years or more. Fee structures split into one-time charges and models with annual or other recurring fees.
Evidence boundary
Every timeline, validity period, and fee amount below comes only from Element 3 or Element 5 of the linked English country page. No number has been inferred from another section. 【待核验】 is preserved where the source page uses it.
Registration timelines and fees by country
| Country | Standard review timeline range | Certificate validity | Fee model | Representative official fee |
|---|---|---|---|---|
| Argentina | Class I: 1–3 months; Class II: 6–14 months; Class III: 12–24 months; Class IV: 18–36+ months | 5 years | Mixed — application plus 5-year renewal fee | Class III: ARS 70,000; Class IV: ARS 93,000 |
| Brazil | Class I: 1–2 months; Class II: 1–3 months; Class III: 18–30 months; Class IV: 36–60 months | Class I/II: indefinite; Class III/IV: 10 years | Mixed — application, 10-year renewal, and BGMP renewal | TFVS: ~BRL 1,000–3,000 (Class I) to ~BRL 30,000–80,000 (Class IV) |
| Canada | — | — | — | — |
| Chile | — | — | — | — |
| Colombia | Class I: 30 business days; Class IIa: 90 business days; Class IIb: 12–18 months practical; Class III: 18–36+ months practical | 10 years | Mixed — application plus 10-year renewal fee | Class I/IIa: COP 3,898,330 |
| Mexico⚑ | Class I: 2–4 months; Class II: 12–18 months; Class III: 18–30 months | Initial: 5 years; renewals: 10 years 【待核验】 | Mixed — application plus 10-year renewal fee | Class I: ~MXN 3,000–8,000; Class II: ~MXN 15,000–40,000; Class III: ~MXN 30,000–80,000 【待核验】 |
| United States | — | — | — | — |
| Australia | — | — | — | — |
| China | Class I: 1–4 weeks; Class II: 8–15 months; Class III: 18–30 months | Class I: indefinite; Class II/III: 5 years | Mixed — registration plus 5-year renewal fee | Imported Class II: CNY 210,900; imported Class III: CNY 308,800 |
| India | Class A/B: 2–6 months; Class C/D: 12–36 months | No fixed expiry; retention fee every 5 years | Mixed — application plus 5-year retention fee | Non-IVD per site + per device: Class A US$1,000 + US$50; Class B US$2,000 + US$1,000; Class C/D US$3,000 + US$1,500 |
| Indonesia | — | 5 years | Mixed — registration plus 5-year renewal fee | NIE: ~IDR 1,500,000 (Class A) to ~IDR 5,000,000 (Class D) |
| Japan⚑ | Class I: under 1 month; Ninsho: 4–12 months; Shonin: 6–24 months depending on pathway and clinical data | No fixed expiry | One-time — product application/review fee | Shonin Class II: ~JPY 1,000,000–2,000,000; Class III: ~JPY 3,000,000–6,000,000 【待核验】 |
| Malaysia | Class A: 3–5 weeks; Full route Class B: 6–10 months practical; Class C/D: 10–18 months practical | 5 years | Mixed — registration, 5-year renewal, and 3-year establishment-licence cycle | Application + registration: Class A RM 500 + RM 750; Class B RM 250 + RM 1,000; Class C RM 500 + RM 2,000; Class D RM 750 + RM 3,000 |
| Philippines⚑ | CMDN: 4–12 weeks; CMDR: up to 180 days; CIVDR initial: ~180 days | Generally 5 years; transitional Class B/C/D CIVDN: 2 years | Mixed — registration plus annual LTO renewal | Legacy CMDR-equivalent: ~PHP 3,000–30,000; live schedule after mid-May 2026 【待核验】 |
| Singapore | Full route: 160 working days (Class B), 220 (Class C), 310 (Class D) | No fixed expiry; annual retention fees apply | Mixed — application/evaluation plus annual product retention and dealer licence | SGD 560 base + Full route SGD 3,900 (Class B), SGD 6,250 (Class C), SGD 12,000 (Class D); retention SGD 39/67/134 per year |
| South Korea⚑ | Class I: 1–2 weeks; Class II certification: 3–6 months; approval routes: 8–24 months | No fixed expiry | One-time — product application/review fee | Class II: ~KRW 100,000–500,000; Class III/IV: ~KRW 500,000–2,000,000 【待核验】 |
| Taiwan | Class I: 1–4 months; Class II: 6–15 months; Class III: 12–24 months | 5 years | Mixed — application plus 5-year renewal fee | Class II: ~NTD 5,000–30,000; Class III: ~NTD 30,000–100,000 |
| Thailand⚑ | Class 1: ~1–8 days; Class 2–3: ~5–8 months; Class 4: ~7–10 months | 5 years | Mixed — submission plus 5-year renewal fee | Submission: ~THB 500 (Class 1) or ~THB 1,000 (Class 2–4); Class 4 expert review: ~THB 53,000 【待核验】 |
| Vietnam⚑ | Type A: 2–6 weeks; Type B: 9–18 months; Type C: 12–24 months; Type D: 18–36+ months | Type B/C/D: 5 years; later indefinite-validity claim 【待核验】 | Mixed — application plus 5-year renewal-cycle cost | Type B/C: ~VND 500,000–2,000,000; Type D: ~VND 2,000,000–5,000,000 |
| European Union | — | — | — | — |
| Russia & EAEU | — | — | — | — |
| Switzerland | — | — | — | — |
| Turkey | — | — | — | — |
| United Kingdom | — | — | — | — |
| Ukraine | — | — | — | — |
| Egypt | — | — | — | — |
| Iran⚑ | — 【待核验】 | 4 years 【待核验】 | Mixed structure reported; application and 4-year renewal amounts 【待核验】 | — 【待核验】 |
| Israel | — | — | — | — |
| Kenya | — | — | — | — |
| Kuwait | — | — | — | — |
| Nigeria | — | — | — | — |
| Saudi Arabia⚑ | Full review: 12–24 months (Class C), 18–36+ months (Class D) | 5 years | Mixed — application, annual establishment maintenance, and 5-year renewal | Class A: SAR 5,000–10,000 to Class D: SAR 35,000–50,000 【待核验】 |
| South Africa | — | — | — | — |
| United Arab Emirates | — | — | — | — |
One-time vs. recurring fee models
| Fee group | Countries | How to read it |
|---|---|---|
| Product fee stated as one-time only | The product approval has no fixed expiry, and Element 5 states the product application/review fee as one-time. Periodic QMS or other compliance costs remain separate. | |
| Annual, retention, or fixed-cycle renewal layer | These pages state an annual fee, a 5-year retention payment, or a fee/cost tied to a fixed renewal cycle. Iran’s amounts remain 【待核验】. |
Planning notes
- A timeline range is a planning baseline, not a regulator commitment. Statutory or published clocks often exclude intake, testing, and applicant-side pauses.
- Deficiency, RFI, and supplementary-information rounds are the largest recurring source of elapsed-time variance; plan response capacity before filing.
- Do not compare the government fee with an all-in project quote. Translation, local testing, authentication, and holder services are separate unless explicitly included.
- For reliance, abridged, expedited, and other rescue routes, use the separate reference-approval leverage matrix; do not substitute its faster clocks for the standard-review column here.
Build the next layer of the market plan
Use the country reports for the complete filing path, or the reference-approval matrix to test whether a reliance or abridged route can shorten the standard timeline.