Global Medical Device Classification Database
Welcome to the Global Medical Device Classification Directory — a searchable resource that helps you find medical devices and their corresponding risk classifications across major regulatory jurisdictions, including US FDA, European Union (EU MDR), Health Canada, IMDRF (International Medical Device Regulators Forum), and CDSCO (India).
This tool allows manufacturers, regulatory professionals, and healthcare organizations
to quickly identify how a device is classified in different markets, ensuring compliance
with global medical device regulations. Each entry is linked with
its IMDRF medical device nomenclature (IMDN) code, helping you
navigate classification rules, risk categories (Class I, IIa, IIb, III / A, B, C, D),
and regulatory requirements across regions.
Use the search box below to look up your device by name or IMDN code, and access risk class mapping across multiple jurisdictions. For deeper insights, selected devices also include internal links to guidance articles and expert discussions on regulatory strategy.
Medical Device Nomenclature - Indicators of Risk Classification Level
Risk classification levels are indicated in the IAF MDN with regard to Canadian, European, GHTF Guidance, and US FDA rules as follows:
| Risk Level | Canada | Europe | GHTF | USA |
|---|---|---|---|---|
| Low Risk | 1 | 1 | A | 1 |
| Medium Low Risk | 2 | 2a | B | 2 |
| Medium High Risk | 3 | 2b | C | |
| High Risk | 4 | 3 | D | 3 |
Medical Device Nomenclature (MDN) Directory
Directory aligned with global risk characterization of medical devices.
👉 Guidance: Select a category (optional) and enter an IMDN Number or Device Name. Click Search to view results, Reset to start over, or Download PDF to export.
Data sources: US Food & Drug Administration (FDA), International Medical Device Regulators Forum (IMDRF), Central Drugs Standard Control Organisation (CDSCO). Classification refreshed regularly as per any notification.