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New Module · Regulatory GPS

Get Your Product Market Ready.

Answer a few questions and instantly discover which certifications, registrations, and documents your product needs — for every country you want to enter.

Start Free AssessmentSee how it works ↓

35

Countries covered

7

Product categories

< 3 min

Time to your report

How it works

Your AI regulatory advisor. In three steps.

Tell us your product and markets. Get an executive intelligence dashboard — not a certification checklist.

01

Tell us about your product.

02

Where do you want to sell?

Click countries to add or remove them. 5 selected

United States— click to removeCanada— click to addMexico— click to addBrazil— click to addArgentina— click to addColombia— click to addUnited Kingdom— click to removeFrance— click to addGermany— click to removeSpain— click to addItaly— click to addNetherlands— click to addSwitzerland— click to addSweden— click to addNorway— click to addPoland— click to addRussia— click to addTurkey— click to addSaudi Arabia— click to addUAE— click to addIsrael— click to addEgypt— click to addNigeria— click to addSouth Africa— click to addKenya— click to addIndia— click to addChina— click to addJapan— click to removeSouth Korea— click to addIndonesia— click to addThailand— click to addPakistan— click to addAustralia— click to removeNew Zealand— click to add
03

Your Executive Intelligence Dashboard.

12mo

Time to First Revenue

Fastest market

$251k

Total Investment

Across all markets

36mo

Full Coverage

All markets approved

49

Documents Required

Unique submissions

Strategy Complexity80/100 — High Complexity
✦

AI Strategy Recommendations

  • ⚡

    FDA 510(k) and CE Mark share ISO 13485 as a foundation. Complete your QMS first — it runs parallel to device classification and accelerates both submissions simultaneously.

  • 💡

    Japan accounts for ~34% of your total investment and requires a domestic Marketing Authorisation Holder. Consider phasing it into Year 2 to protect cash flow.

  • 🔗

    UK and EU have diverged post-Brexit but share ~85% of documentation requirements. Complete your EU Technical File first — UKCA submission is then incremental.

Next Best Action

Establish Your QMS (ISO 13485)

ISO 13485 certification is the critical path item for both FDA and CE Mark. Without it, neither submission can proceed. This is where you start.

⏱ 3–6 months to certify

Market Breakdown

Scenario Planner

See the impact of removing a market from your strategy.

🇺🇸United States

If removed:

saves $80k

🇬🇧United Kingdom

If removed:

saves $25k

🇩🇪Germany

If removed:

saves $42k

🇯🇵Japan

If removed:

saves $85k · −12mo on critical path

🇦🇺Australia

If removed:

saves $19k

MarketTimelineInvestment
🇬🇧United Kingdom
12mo$15–35k
🇺🇸United States
18mo$40–120k
🇦🇺Australia
18mo$12–28k
🇩🇪Germany
24mo$25–60k
🇯🇵Japan
36mo$45–130k

Export Your Report

Download a formatted PDF of your full market readiness analysis.

General educational content only. Cost and timeline estimates are indicative ranges based on typical regulatory pathways. Actual requirements, timelines, and costs vary by product class, intended use, jurisdiction, and regulatory history. This does not replace qualified regulatory, legal, or clinical advice.

Ready to start?

Know before you spend.

Regulatory surprises kill timelines and budgets. Regulatory GPS gives you a clear, structured market-readiness picture in minutes — not months.

Start Free Assessment

General educational content only. Does not replace qualified regulatory advice.