Country comparison
Device definition & scope by country
Is the product a device, IVD, accessory, software, or borderline product locally?
1 markets1 facts1 official sourcesreviewed through 2026-08-24
| Market | Source-linked requirements | Official sources | Last checked |
|---|---|---|---|
| 🇨🇴 Colombia INVIMA All country facts → | General medical-device scope Decree 4725 regulates medical devices for human use and excludes IVD reagents and custom made devices from this decree's general scope. | 2026-08-24 |
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