Brazil
ANVISA · 7 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
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
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
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 · 14 resources
European Union
EU MDR · 8 resources
China
NMPA · 7 resources
Japan
PMDA · 7 resources
Mexico
COFEPRIS · 7 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 →Classification agents, company lookups, daily regulatory news, and a job board — built on the same open data.
AI
AI Device ClassifiersCheck a medical device risk class across 37 countries, with explanations and source links
FA
FDA Predicate & Pathway AgentCross-search FDA classifications and premarket databases for product-code, pathway, and predicate directions
GS
EU MDR GSPR ChecklistMap applicable Annex I evidence areas, track gaps, and download a working summary
13
ISO 13485 Audit ChecklistAssess medical device QMS readiness, capture evidence notes, and build an internal audit worklist
MS
MDSAP Audit ChecklistReview QMS evidence and country-specific readiness across five 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?