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New Module · Regulatory GPS

Get your product market ready.

Answer a few questions and GHMAP assembles the certification, registration, and document questions to review for every country you want to enter — with source status on each one, for professional review.

Start the assessmentRegulatory Pathway Brief — $1,800Request a fit check first
app.ghmap.io / regulatory / pathway-readiness

Pathway stages

  1. Classification
  2. Evidence review
  3. 3Dossier preparation
  4. 4Authority review
  5. 5Registration

46% of pathway questions resolved

Evidence dossier

Example only
  • Technical fileReviewed
  • Clinical evaluationIn review
  • Local labelingSource required
  • Free sale certificateTo be verified

Source status: 12 of 15 items verified against authority sources

Suggested next step: appoint a notified body

Country profiles with regulatory data
35+
Product categories, from Device to SaMD
7
Of items carry source status
100%
Reviewed brief to take to your board
1

Authorities covered in this assessment

  • FDA · USA
  • EMA · EU
  • PMDA · Japan
  • MHRA · UK
  • TGA · Australia
  • Health Canada
  • NMPA · China
  • ANVISA · Brazil
  • SFDA · Saudi Arabia
  • MFDS · South Korea

How it works

Set your scope, and GHMAP organises the questions.

Choose a product category and the markets you want to enter. GHMAP assembles the certification, timeline, and investment questions to review for each one — as planning input for professional review, not a regulatory determination.

Step 01

Tell us about your product

Scope: Medical Device

Step 02

Where do you want to sell?

5 selected
app.ghmap.io / regulatory-gps / target-markets

Start from a preset

35 markets carry Medical Device data

Step 03

Your executive intelligence view.

One organised read of the selected markets: pathway load, indicative investment, the documents to prepare, and the questions to take into professional review.

Est.

0 mo

Earliest pathway completion

Fastest selected market

Est.

$0k

Indicative total investment

Sum of mid-point ranges

Est.

0 mo

Longest pathway

Critical path across markets

Est.

0

Documents to prepare

Key items across markets

Planning estimate — to be verified. Figures are indicative planning ranges compiled from GHMAP country data — not quoted prices, authority commitments, or approval timelines.

Capital planning

Indicative investment by market

Mid-point of each market's indicative cost range ($k). Planning estimate — to be verified.

Portfolio load

Complexity mix

  • Moderate2
  • Complex3

Strategy complexity80/100

High complexity

Sequencing

Pathway timeline by market

Upper bound of each market's typical pathway range. Planning estimate — to be verified — not an authority commitment.

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

Suggested planning step and indicative duration — to be verified. Not regulatory, legal, or investment advice.

Generated suggestions

Strategy recommendations

  • Run FDA and CE tracks in parallelFDA 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 dominates the budgetJapan accounts for ~34% of your indicative total investment and requires a domestic Marketing Authorisation Holder. Consider phasing it into year two to protect cash flow.
  • Sequence EU first, then UKUK and EU have diverged post-Brexit but share most documentation requirements. Complete your EU technical file first — the UKCA submission is then incremental.

Generated planning suggestions for review. Not regulatory, legal, or investment advice, and not a guarantee of approval or market entry.

Market breakdown

Certifications to review, market by market

Trade-offs

Scenario planner

See the impact of removing a market from your strategy.

  • United KingdomIf removed−$25k indicative
  • United StatesIf removed−$80k indicative
  • AustraliaIf removed−$19k indicative
  • GermanyIf removed−$42k indicative
  • JapanIf removed−$85k indicative · −12 mo on critical path

Planning estimate — to be verified. Removing a market changes the planning figures only — it is not a commercial or regulatory recommendation.

Side-by-side

Market comparison grid

app.ghmap.io / regulatory-gps / market-comparison
MarketTimeline (est.)Investment (est.)
United Kingdom~12 mo$15–35k
United States~18 mo$40–120k
Australia~18 mo$12–28k
Germany~24 mo$25–60k
Japan~36 mo$45–130k

Planning estimate — to be verified — example workspace view

Export your report

Download a formatted PDF of your market readiness analysis — KPIs, per-market certifications, and the review disclaimer included.

General educational content only. Cost and timeline ranges are indicative planning input based on typical regulatory pathways.

Regulatory team reviewing a market-entry dossier against global market data

From assessment to decision

Turn this assessment into a reviewed pathway brief.

The tool above organises the questions. The brief answers which ones matter most for your product — reviewed, sourced, and sequenced into a launch plan.

  • Reviewed pathway briefYour assessment restructured as a board-ready brief: per-market pathway questions, evidence flags, and a gap list — reviewed by a regulatory professional.
  • Source status on every itemEach certification, document, and timeline carries its source and verification state, so your QA/RA team knows exactly what still needs confirming.
  • A review call that decidesWalk through the brief with a specialist, pressure-test your sequencing, and leave with a wave-one market list you can defend internally.

Evidence

Evidence your QA/RA team can defend.

Every number in your assessment traces back to a country profile — authority, classification system, timelines, and documents — each tagged with its source and review state, like any inspection record.

Browse registration pathwaysExplore coverageCountry intelligence

Compare country and device-class registration overviews such as EU MDR Class IIa and FDA 510(k) Class II. Source status applies; professional review required.

Illuminated world map showing connected healthcare markets on a strategy table

Next step

Turn this assessment into a reviewed pathway brief

Regulatory Pathway Brief — $1,800, delivered in 7–10 business days. Or the Market Entry Sprint — $2,500, with evidence flags, a gap list, and a review call.

Pay $1,800 — Regulatory Pathway BriefPay $2,500 — Market Entry SprintPrefer a fit check firstBrowse registration pathways

General educational content only. Does not replace qualified regulatory advice.GHMAP does not guarantee regulatory approval, reimbursement, or market entry.