19 free tools · 24 jurisdictions · no AI required
Regulatory Intelligence Every tool a regulatory professional, manufacturer, importer, or consultant needs — device classification, process flows, comparison tables, checklists, gap analysis, and more.
Device Classifier
CLASSIFIER
Device Classification Wizard
5 questions. Indicative classification, documentation checklist, and pathway timelines across all 24 RAPath jurisdictions. Includes Quick Screener and SaMD track.
General Tools
VISUAL
Regulatory Process Flow
Interactive 7-phase flowchart with jurisdiction-specific notes and per-phase checklists.
ANALYSIS
Jurisdiction Comparison Tables
Side-by-side comparison of PMS, UDI, authorised reps, vigilance, and QMS across 24 markets.
PLANNING
Regulatory Timeline Planner
Gantt-style view of overlapping regulatory phases, adjustable by device class.
REFERENCE
Acronym & Glossary Lookup
Searchable glossary of 100+ regulatory terms and acronyms across all 24 jurisdictions.
STRATEGY
MDSAP Value Map
What MDSAP gets you in each jurisdiction — full recognition, partial credit, or no benefit.
For Manufacturers
TECHNICAL
GSPR / Essential Req. Mapper
Map applicable General Safety & Performance Requirements to your device type with evidence guidance.
CLINICAL
Clinical Evidence Calculator
Determine the level of clinical evidence required by device class, novelty, and equivalence approach.
LABELLING
Labelling Requirements Checker
Mandatory label elements, language requirements, eIFU eligibility, and UDI placement by jurisdiction.
POST-MARKET
Post-Market Obligations Calendar
What you must do — and when — after market entry. Vigilance timeframes, PSUR cycles, and renewal windows across all 24 jurisdictions.
PLANNING
Regulatory Fee Estimator
Approximate government registration fees per jurisdiction — planning purposes only.
For Importers & Distributors
IMPORT
Import Requirements Checker
Licences, permits, and appointments an importer needs before a device can legally cross the border.
COMPLIANCE
Distributor Obligations Guide
Verification steps, record-keeping obligations, when relabelling triggers manufacturer status, FSCA duties.
ACTION
Submission Readiness Checklist
Track submission readiness across 42 items with a live progress bar.
For RA Consultants
STRATEGY
Regulatory Gap Analysis
Already approved in one market? Identify what extra requirements apply for each new target jurisdiction.
IVD
IVD Classification Track
Dedicated IVD classifier — EU IVDR List A/B, FDA, TGA, HSA; analyte type, professional vs self-test.
COMPLIANCE
Economic Operator Map
Required roles — manufacturer, importer, authorised rep — and their legal obligations per jurisdiction.
Software & SaMD
SAMD
SaMD Decision Tree
IMDRF N41 risk matrix with FDA classification mapping and 'is my app a medical device?' screener.
SOFTWARE
Cybersecurity Requirements
Cybersecurity standards, SBOM requirements, documentation obligations, pre and post-market duties by jurisdiction.
Independent open-source project. All tools are based on publicly available regulatory information and provide indicative guidance only — not regulatory or legal advice.rapath.org