Medical-device intelligence

The reference layer for medical devices.

MedevIQ reconciles India’s regulatory record — every CDSCO-licensed manufacturer, device and risk class — with the global one of FDA clearances, EU registrations and worldwide safety signals, in a single canonical profile per manufacturer and device. Built for regulatory affairs, quality and procurement teams that work from cited records.

Access by invitation while v1 finalizes.

5,195
India manufacturers
161K
India device licences
5.1M
Devices, 7 regulators
23M+
Adverse-event reports
Infusion pump · Class C · 510(k) K-cleared

Siemens Infusomat Space

Siemens Healthcare Pvt Ltd · CDSCO + FDA + EUDAMED listed
Illustrative · Trust tier A2

⚠ RecallClass II · battery latch — corrective field action, 2024-08, FDA + Health Canada
! MAUDE signalFree-flow events · 412 reports · PRR 2.8 · MAUDE 2018–2024
Regulatory sources · CDSCO · FDA 510(k) · EUDAMED UDI-DI · Health Canada MDL
Safety sources · FDA MAUDE · FDA recalls · EUDAMED FSCA · HC vigilance
3,471
India licences
30
FDA clearances
2
Active recalls
Reconciled acrossCDSCOFDAopenFDAGUDIDMAUDEEUDAMEDHealth CanadaTGAPMDAMHRA
The problem

India’s device market has no intelligence layer of its own.

India is among the world’s fastest-growing medical-device markets and remains substantially import-dependent. CDSCO licensing is divided between central and state authorities under a still-maturing device-rules regime, and the intelligence tools that exist are built for US and EU pharma — they do not structure India’s domestic device base. Hospitals, manufacturers and regulators decide on scattered, single-jurisdiction data.

Coverage

India in depth, the world alongside.

Reconciled across seven regulators — CDSCO, FDA, EUDAMED, Health Canada, TGA, PMDA and MHRA. The figures below are current-build counts, refreshed as new data lands.

5,195
India manufacturers
CDSCO, manufacturing + import
161K
India device licences
94K manufacturing + 67K import
5.1M
Devices canonical
FDA GUDID + EUDAMED + CDSCO + HC + TGA + MHRA + PMDA — deduplicated
23M+
Adverse-event reports
openFDA MAUDE
433K
Regulatory clearances
510(k) + PMA + TGA + PMDA + HC + EUDAMED
1.7M
EU UDI-DI records
EUDAMED public registry
India intelligence

The CDSCO base, connected to each maker’s global footprint.

5,195 manufacturers and importers and 161,000 device licences across 29 states and risk classes A–D — each with intended-use detail, and each linked to the same company’s FDA clearances and global safety record. The domestic base no global tool covers.

Cross-regulator linking

One profile, every regulator.

The connection is the product: the same device or maker, reconciled across jurisdictions, with the safety and regulatory record attached.

Cross-regulator profiles

A device or manufacturer reconciled across CDSCO, FDA, EUDAMED, Health Canada and TGA — joined at the entity level, not chased across portals.

Adverse-event signals

MAUDE reports surfaced with disproportionality scoring (PRR), severity and date-of-event, per device family and per manufacturer.

Recall tracking

FDA and Health Canada recalls joined to the record, with class, reason and status. EU FSCAs added as published.

Manufacturer-canonical

One company, many name variants, resolved to a single identifier — so India and global records line up rather than fragmenting on spelling.

Who it’s for

Free for those who learn and research; built for those who buy and oversee.

Safety and reference data are open to the people incumbents price out — researchers, students and clinicians. The synthesis, cross-rail and procurement depth is what institutions pay for.

Institutional — the paying tier

Hospitals & procurement

Device choice, equivalents, recall history, manufacturer reliability, and tier-appropriate kits with INR costing.

Device manufacturers

Competitive and regulatory comparison — who is licensed in which classes, set against the global record.

Government & regulators

Tender intelligence across facility tiers; cross-regulator vigilance signals and recall chronologies.

MNCs

India coverage existing tools lack, cross-linked to a global portfolio for market access and competitive intelligence.

Open — the academic and public tier

Researchers & academics

Structured, cited, cross-regulator device data with transparent sourcing — and, in time, cross-rail links to drugs and biologics.

Medical & biomedical students

A free, sourced device reference for training — India's next clinicians, engineers and procurement leads.

Clinicians & the public

Device safety, recall and regulatory status — open and free, on every profile.

Methodology

Every claim carries its source.

Data is presented at an explicit trust tier and refreshed on a stated cadence. Expert clinical verification is the funded next step; until a field is reviewed, it is marked as registry or AI-reviewed, not verified.

Read the methodology →

Sourcing per field

Each fact carries its source and retrieval date. No claim is unsourced.

Trust tiers

Registry-only and AI-reviewed (cross-checked) are live today; expert review (clinical sign-off) is rolling out as the review board is onboarded.

Safety stays free

Recall and adverse-event data are public on every profile, refreshed on a short cycle.

Refresh cadence

Safety-critical fields refresh on a 60-day cycle; regulatory and classification on 180. Last refresh shown on each page.

Early access

MedevIQ is in private preview.

We're onboarding hospitals, manufacturers, regulators and research teams in waves. Tell us how you'd use MedevIQ and we'll get back within a working week.

We'll reply within a working week.

Access by invitation while v1 finalizes.