Data Methodology
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.
Sources & coverage
- Device registration databases — 37 countries, each synced from the national regulator's public registry (see table below).
- Regulations library — 269 regulations and guidance documents, linked to their official publications.
- Registration timelines — 29 countries, compiled from official published review targets and our consulting practice's observed timelines.
- Government fees — 31 countries, from official fee schedules, converted at indicative exchange rates.
- 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 | AKPTM | 4,000+ | Search → |
| Argentina | ANMAT | 5,000+ | Search → |
| Australia | TGA | 131,000+ | Search → |
| Bangladesh | DGDA | 3,000+ | Search → |
| Belarus | Ministry of Health | 5,000+ | Search → |
| Brazil | ANVISA | 109,598+ | Search → |
| Canada | Health Canada | 34,000+ | Search → |
| China | NMPA | 149,000+ | Search → |
| Colombia | INVIMA | 8,000+ | Search → |
| Cuba | CECMED | 2,000+ | Search → |
| Ecuador | ARCSA | 176,000+ | Search → |
| EU | EUDAMED | 563,000+ | Search → |
| Hong Kong | MDACS | 15,000+ | Search → |
| India | CDSCO | 71,807+ | Search → |
| Indonesia | BPOM | 67,600+ | Search → |
| Israel | Ministry of Health | 22,000+ | Search → |
| Japan | PMDA | 88,000+ | Search → |
| Macau | DSSA | 110+ | Search → |
| Malaysia | MDA | 57,000+ | Search → |
| Mexico | COFEPRIS | 12,000+ | Search → |
| Myanmar | FDA | 5,000+ | Search → |
| Pakistan | DRAP | 6,600+ | Search → |
| Peru | DIGEMID | 33,000+ | Search → |
| Philippines | FDA | 18,000+ | Search → |
| Russia | Roszdravnadzor | 23,000+ | Search → |
| Saudi Arabia | SFDA | 15,000+ | Search → |
| Serbia | Medicines and Medical Devices Agency | 234 | Search → |
| Singapore | HSA | 28,000+ | Search → |
| South Africa | SAHPRA | 2,200+ | Search → |
| South Korea | MFDS | 314,000+ | Search → |
| Taiwan | Taiwan FDA (TFDA) | 89,088+ | Search → |
| Tanzania | TMDA | 3,100+ | Search → |
| Thailand | Thailand FDA | 4.4M+ | Search → |
| Turkey | Turkish Medicines and Medical Devices Agency | 21,278+ | Search → |
| UK (MHRA) | MHRA | 150,962+ | Search → |
| USA | FDA | 120,000+ | Search → |
| Vietnam | Ministry of Health | 314,986+ | 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.
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.