Sources, codifications, regulatory crosswalks, verification cadence, versioning, and editorial governance. The complete reference for anyone evaluating the catalogue's reliability before citing it.
Every record traces to a public, regulator, or standards-body source. Records are compiled from regulator publications, standards bodies, and manufacturer-disclosed regulatory filings — never from internal estimates. Where multiple sources disagree, the most recent regulator publication takes precedence and the conflict is logged in the record's audit trail.
Cross-walks between coding systems (GMDN ↔ UMDNS, ICD-10-PCS ↔ CPT, HSN ↔ HS-WCO) are derived from official mapping tables published by the relevant authorities. Derived crosswalks are tagged distinctly from authoritative ones in the academic_source_basis field surfaced through the API.
13 regulatory regimes are tracked: CDSCO (India), FDA (US), CE/IVDR (EU), UKCA (UK), PMDA (Japan), TGA (Australia), NMPA (China), MFDS (Korea), Health Canada, ANVISA (Brazil), AERB (India radiological), BIS QCO (India quality), and WHO PQS for prequalified products. Status is captured per device per regime.
Devices are mapped to a 7-tier hospital framework (T1–T7) derived from IPHS norms and adapted for tertiary and quaternary care. Each device records a min_hospital_tier_code indicating the lowest tier at which the device is required.
Cadence is documented per entity type. Devices and manufacturers are reviewed quarterly. Regulatory status is reviewed monthly for high-risk classes (C/D) and quarterly for low-risk (A/B). Records that fall out of cadence are flagged for re-verification before the next release.
Each release is assigned a semantic version (major.minor.patch) and a DOI via Zenodo. Patch releases fix data quality issues without schema changes; minor releases add fields or entities; major releases break compatibility. Citation strings always reference a specific version.
Each editor is independent, holds no equity in or consulting relationships with any medical device manufacturer covered by the catalogue, and discloses such relationships annually in this document. The MedevIQ project accepts no manufacturer funding.
The full data quality audit report is published alongside each release. Read the v1.0.0 audit on Zenodo →