Free regulatory tools, organized by what you need to do.
Search official records, compare markets, or use AI to classify, plan, review, translate, fill forms, and create editable regulatory outputs.
Data & research
Search official records and clinical evidence, inspect market activity, and read source regulations.
Device Registrations
Search device registrations across 36 markets
Medical Device UDI Database
Search authoritative device identifiers separately from market registrations and approvals
Global Product Search & Compare
Search one medical device across multiple country registries and compare public records
AI Search
Ask questions in plain language across registrations, fees, timelines, regulations, and news — answers cite real registry records
FDA Product Code Lookup
Find device classes, product codes, regulation numbers, and premarket pathways
FDA Medical Device Recalls
Search recall events, affected products, firms, reasons, and corrective actions
FDA MAUDE Safety Reports
Search FDA medical device adverse event reports by product, company, or product code
FDA GUDID / UDI Lookup
Find device identifiers, labelers, models, product codes, and labeling attributes
FDA PMA Approvals
Search Class III Premarket Approval applications, decisions, and supplements
FDA De Novo Decisions
Find granted requests, new classifications, product codes, and decision dates
FDA Registration & Listing
Search registered establishments, owner/operators, and listed medical devices
FDA TPLC Intelligence
Connect classification, premarket, listing, recall, MAUDE, and GUDID records by product code
FDA Recognized Standards
Search current FDA recognition records by title, designation, product code, or recognition number
EMDN Code Finder
Search the official European nomenclature by code or plain device description
Registry Insights
Explore market trends, manufacturers, holders, and registration activity
Device Directory
7,000+ FDA device types with product codes, classes, definitions, and registration-research links
Clinical Trials
Search clinical trial records across 38 countries
CER Evidence Finder & Workpaper
Find candidate evidence, preserve the exact search, and compose source-linked screening, study, outcome, appraisal, and claim-evidence tables
Regulations Library
Official medical device regulations from 38 jurisdictions
Planning & comparison
Compare lifecycle requirements, registration routes, government fees, and timelines across markets.
Global Registration Planner
Estimate pathways, government fees, dossier preparation, review timelines, and steps across up to five markets
Registration Timelines
Compare source-linked regulator clocks and planning ranges across 29 markets
Government Fees
Compare fee schedules for 31 countries with row-level source status
Global Regulatory Data
Compare source-linked medical-device lifecycle requirements across markets and regulatory dimensions
RA & quality workpapers
Paste real working material and turn it into an evidence-based regulatory or quality workpaper.
Global Market Launch Workpaper
Connect routes, representatives, testing, dossier, labels, timing, and dependencies across target markets
Dossier Gap Analysis
Map existing, partial, conflicting, planned, and missing dossier evidence into an attachment worklist
Dossier Reuse & Market Delta
Compare an existing authorization and evidence set against new target-market requirements
Standards & Testing Matrix
Connect product characteristics to candidate standards, test families, current sources, and evidence gaps
Submission Package Preflight
Check content, repeated facts, file quality, signatures, portal mapping, and release blockers
Change Notification Workpaper
Map one product change across registrations, evidence deltas, notification questions, and implementation gates
IVD Analytical Performance Review
Review precision, range, interference, specimens, traceability, stability, and clinical-performance links
Medical Device Cybersecurity Review
Review security architecture, risks, SBOM, controls, testing, submissions, and vulnerability management
FDA Q-Submission Readiness
Structure FDA decisions, sponsor positions, predicates, evidence plans, questions, and meeting preparation
Regulatory Change Impact
Test a current regulatory update against one product and create an owner-ready action workpaper
Amazon Health Product Compliance
Review listing claims, packaging, labels, evidence, certificates, and likely document requests
AI Risk Management File Review
Review hazards, controls, verification, residual risk, traceability, and post-market updates
FDA eSTAR Readiness Agent
Map a submission evidence index to missing sections, attachments, and technical-screening risks
AI CAPA Investigation Builder
Structure containment, root-cause hypotheses, actions, effectiveness, and risk linkage
Complaint & FSCA Workpaper
Screen incident facts, reporting paths, health risk, field actions, and communications
AI FDA QMSR Gap Review
Review implementation evidence, records, risk, suppliers, CAPA, and inspection readiness
AI Label & IFU Review
Review intended use, warnings, directions, UDI, symbols, claims, and market gaps
AI PMS, PMCF & CER Review
Connect post-market signals, clinical evidence, risk, CAPA, and lifecycle reports
AI tools & updates
Complete regulatory tasks with free AI tools, then stay current with global regulatory updates.
Blog
Practical workflows, tutorials, product updates, and insights for regulatory teams
AI Device Classifiers
Check a medical device risk class across 41 markets, with explanations and source links
Additional Certification Checker
Check radio, electrical, metrology, radiation, import, and other conditional requirements across 40 markets
Regulatory Product Master
Turn company, site, product, model, approval, certificate, claim, and evidence notes into reusable JSON and Excel
Official Form Fillers
Paste source material and download AI-prepared official ANVISA and COFEPRIS Word or Excel form drafts
Classification Form Filler
Prepare the ANVISA classification form from pasted product facts
Model List Filler
Prepare the ANVISA model-list template from pasted product portfolios
Regulatory Letter & Document Builders
Create editable cover letters, authorization and representation letters, declarations, statements, and certificate request drafts
Medical Device Translation Tools
Free IFU, label, technical dossier, FDA document, and regulatory submission translation tools
Similar Product Finder
Describe a product and search country registration databases for comparable registered medical devices
FDA Predicate & Pathway Agent
Cross-search FDA classifications and premarket databases for product-code, pathway, and predicate directions
EUDAMED UDI XML Generator
Paste UDI source material in any format and generate preflighted EUDAMED bulk-upload XML
AI EU MDR GSPR Gap Review
Paste technical-document evidence and get Annex I findings, missing evidence, and priority actions
AI ISO 13485 Gap Review
Paste QMS evidence and get an implementation-focused audit worklist
AI MDSAP Gap Review
Review QMS and country-specific evidence across participating markets
Company Registry
Search medical device companies across multiple countries
Regulation News
Daily regulatory news from official global sources
Regulatory Jobs
FDA 510(k), EU MDR, clinical affairs and quality positions
Podcast
Global market access insights in 20 languages
Classification Game
Test your knowledge of ANVISA device classification
Expert guidance from Pure Global
Pure Global AI provides free regulatory data and AI tools. For expert review, registration execution, authority interaction, and local representation, continue to the consulting site.
Country Market Guides
Practical registration pathways and market-entry guidance for 30+ markets
Regulatory Insights
Articles, case studies, and analysis written by regulatory specialists
Global Registration Services
Plan and coordinate multi-market dossiers, submissions, and lifecycle maintenance
In-Country Representation
Understand local representative, sponsor, and registration-holder support
Pricing Calculator
Estimate service pricing by market, device risk, and portfolio size
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