How Pure Global AI keeps regulatory data honest
Every number on this site traces back to a primary source, a review date, and a declared verification state.
Every dataset on Pure Global AI is sourced from official government registries and public regulatory documents. This page documents where each dataset comes from, what it covers, and what its limitations are — so you can decide how much to rely on it. For model, workflow, structured-output, protection, and human-review details, read the AI Agent Methodology.
Verification states
Three states cover everything you see:
Sources & coverage
- Device registration databases — 38 countries, each synced from the national regulator's public registry (see table below).
- Regulations library — 461 regulations and guidance documents, linked to their official publications.
- Registration timelines — 78 countries. Primary-source-linked regulator clocks are marked as verified; every unlinked clock and end-to-end range is presented as a planning estimate.
- Government fees — 79 countries. Rows checked against a regulator fee schedule include the original link and review date; remaining rows stay visibly marked as planning estimates. USD conversions use indicative exchange rates.
- Additional certification applicability — 408 maintained country-scheme decisions across 82 markets, with 475 regulator and government source links. The matrix distinguishes product certificates, dossier evidence, import documents, and site or operator licences; missing product facts never become an assumed exemption.
- Regulation news — aggregated daily from official regulator announcements and industry sources; each item links to its original source.
- Clinical trials — compiled from public clinical trial registries across 40 countries.
Device database registry sources
| Country | Regulatory body | Records | Database |
|---|---|---|---|
| Albania | AKBPM | 4k | Search → |
| Argentina | ANMAT | 47k | Search → |
| Australia | TGA | 62k | Search → |
| Bangladesh | DGDA | 4.4k | Search → |
| Belarus | Ministry of Health | 5k | Search → |
| Brazil | ANVISA | 103k | Search → |
| Canada | Health Canada | 301k | Search → |
| China | NMPA | 45k | Search → |
| Colombia | INVIMA | 391k | Search → |
| Cuba | CECMED | 2k | Search → |
| Ecuador | ARCSA | 254k | Search → |
| Egypt | EDA | 4.3k | Search → |
| European Union | EU MDR | 563k | Search → |
| Hong Kong | MDD | 14.5k | Search → |
| India | CDSCO | 71k | Search → |
| Indonesia | Ministry of Health | 82.1k | Search → |
| Israel | AMAR | 29.9k | Search → |
| Japan | PMDA | 89k | Search → |
| Macau | ISAF | 110 | Search → |
| Malaysia | MDA | 49.7k | Search → |
| Mexico | COFEPRIS | 22k | Search → |
| Myanmar | FDA Myanmar | 5k | Search → |
| Pakistan | DRAP | 7k | Search → |
| Peru | DIGEMID | 33k | Search → |
| Philippines | FDA Philippines | 18k | Search → |
| Russia | Roszdravnadzor | 23k | Search → |
| Saudi Arabia | SFDA | 231k | Search → |
| Serbia | ALIMS | 234 | Search → |
| Singapore | HSA | 20.8k | Search → |
| South Africa | SAHPRA | 2k | Search → |
| South Korea | MFDS | 314k | Search → |
| Taiwan | TFDA | 104k | Search → |
| Tanzania | TMDA | 3k | Search → |
| Thailand | Thai FDA | 4.4M | Search → |
| United Arab Emirates | EDE | 4.7k | Search → |
| United Kingdom | MHRA | 150k | Search → |
| United States | FDA | 156k | Search → |
| Vietnam | Ministry of Health | 92.8k | Search → |
Update cadence
Regulation news is aggregated daily. Registration databases are re-synced on a per-source schedule that follows how often each registry publishes updates — some registries publish daily, others monthly or irregularly. Record counts shown across the site are updated with each sync. Fee and timeline tables are reviewed on fiscal-year changes and authority announcements; each dataset page shows its own last-import date.
Known limitations
- Field completeness varies by registry: some sources publish only a device name, registration number, and holder.
- Registries occasionally correct or remove records; our copy can briefly lag the source of truth. When in doubt, verify against the official registry linked from each record.
- Fee amounts and timelines change with regulation updates; figures here are indicative and not a substitute for official confirmation.
- Nothing on this site is legal or regulatory advice. For submission decisions, consult a qualified professional — or talk to Pure Global.
How to cite this data
You are welcome to cite or reference any dataset on this site. Suggested format:
Pure Global AI, "[Dataset name]", pureglobal.ai, accessed [date]. https://pureglobal.ai/[dataset-url]
For press or research inquiries about the data, contact info@pureglobal.com.

