Brazil
ANVISA · 9 resources
Free · Open · Official sources
Every device registration
on the map.
37 national registries, 1.9M+ device registrations, clinical trials, government fees and approval timelines — one open dataset for global market access, built by Pure Global.
37
Country databases
1.9M+
Device registrations
7,000+
FDA device types
31
Government fee schedules
29
Approval timelines
Explore by resource
View all resources →Start with the question you need to answer, then compare the same resource across markets.
DR
Device Registrations
Search device registrations across 37 countries
GC
Global Product Search & Compare
Search one medical device across multiple country registries and compare public records
PC
FDA Product Code Lookup
Find device classes, product codes, regulation numbers, and premarket pathways
RC
FDA Medical Device Recalls
Search recall events, affected products, firms, reasons, and corrective actions
MD
FDA MAUDE Safety Reports
Search FDA medical device adverse event reports by product, company, or product code
UD
FDA GUDID / UDI Lookup
Find device identifiers, labelers, models, product codes, and labeling attributes
PM
FDA PMA Approvals
Search Class III Premarket Approval applications, decisions, and supplements
DN
FDA De Novo Decisions
Find granted requests, new classifications, product codes, and decision dates
ER
FDA Registration & Listing
Search registered establishments, owner/operators, and listed medical devices
TL
FDA TPLC Intelligence
Connect classification, premarket, listing, recall, MAUDE, and GUDID records by product code
ST
FDA Recognized Standards
Search current FDA recognition records by title, designation, product code, or recognition number
EM
EMDN Code Finder
Search the official European nomenclature by code or plain device description
IN
Registry Insights
Explore market trends, manufacturers, holders, and registration activity
DD
Device Directory
7,000+ FDA device types with global registration data
CT
Clinical Trials
Medical device clinical trials from 40 countries
RL
Regulations Library
Official medical device regulations from 38 countries
RP
Global Registration Planner
Estimate pathways, government fees, dossier preparation, review timelines, and steps across up to five markets
RT
Registration Timelines
Compare approval timelines across 30 countries
GF
Government Fees
Official registration fees for 31 countries
Explore by country
View all countries →Pick a market once, then find every database, regulation, fee schedule, timeline, insight, update, and tool available for it.
United States
FDA · 20 resources
European Union
EU MDR · 12 resources
China
NMPA · 9 resources
Japan
PMDA · 9 resources
Mexico
COFEPRIS · 9 resources
Compare countries
Open comparison tables →Planning a multi-market launch? Put approval timelines and official government fees side by side.
Free tools & AI agents
Browse all resources →Bring real regulatory work: classify a device, search official data, review evidence, or build a submission, CAPA, risk, labeling, and post-market workpaper.
RM
AI Risk Management File ReviewReview hazards, controls, verification, residual risk, traceability, and post-market updates
ES
FDA eSTAR Readiness AgentMap a submission evidence index to missing sections, attachments, and technical-screening risks
CA
AI CAPA Investigation BuilderStructure containment, root-cause hypotheses, actions, effectiveness, and risk linkage
FS
Complaint & FSCA WorkpaperScreen incident facts, reporting paths, health risk, field actions, and communications
QS
AI FDA QMSR Gap ReviewReview implementation evidence, records, risk, suppliers, CAPA, and inspection readiness
LB
AI Label & IFU ReviewReview intended use, warnings, directions, UDI, symbols, claims, and market gaps
CL
AI PMS, PMCF & CER ReviewConnect post-market signals, clinical evidence, risk, CAPA, and lifecycle reports
AI
AI Device ClassifiersCheck a medical device risk class across 37 countries, with explanations and source links
SP
Similar Product FinderDescribe a product and search country registration databases for comparable registered medical devices
FA
FDA Predicate & Pathway AgentCross-search FDA classifications and premarket databases for product-code, pathway, and predicate directions
GS
AI EU MDR GSPR Gap ReviewPaste technical-document evidence and get Annex I findings, missing evidence, and priority actions
13
AI ISO 13485 Gap ReviewPaste QMS evidence and get an implementation-focused audit worklist
MS
AI MDSAP Gap ReviewReview QMS and country-specific evidence across participating markets
CR
Company RegistrySearch medical device companies across 6 countries
RN
Regulation NewsDaily regulatory news from official global sources
RJ
Regulatory JobsFDA 510(k), EU MDR, clinical affairs & quality positions
PC
PodcastGlobal market access insights in 20 languages
CG
Classification GameTest your knowledge of ANVISA device classification
“AI and open data as a force for global good.”
Ran Chen, CTO @ Pure Global — why we publish this data for free
Where this data comes from
Every dataset is sourced from official regulatory registries (FDA, ANVISA, EUDAMED, NMPA, PMDA, and more), refreshed on a per-source schedule, and published with its coverage and known limitations documented.
Read the methodologyNeed expert help with a registration?
The data is free. When you need people, Pure Global provides end-to-end regulatory consulting and in-country representation.
DJ Fang
MedTech Regulatory Expert
Need help confirming a classification or planning your registration?