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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 regulator has not published the figure or the country page has not yet verified it.
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 the review-timeline and official-fee sections 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 | New imported-device registration: up to 21 working days (Class A), 36 (Class B/C), 55 (Class D) | No fixed term in the current standard; renew at least 9 months before expiry | Mixed — registration plus 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 | — | 5 years | Mixed — registration fee, annual retention fee and renewal fee | Registration: USD 100 (Class A) to USD 1,000 (Class C/D), imported products |
| 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 the fee section of the country page 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.