Country comparison
Dossier requirements by country
Which evidence, local deltas, formats, and signatures are required?
2 markets2 facts2 official sourcesreviewed through 2026-08-24
| Market | Source-linked requirements | Official sources | Last checked |
|---|---|---|---|
| 🇧🇷 Brazil ANVISA All country facts → | Dossier checklist source The mandatory document list is the checklist for the selected subject code. | 2026-08-24 | |
| 🇨🇴 Colombia INVIMA All country facts → | Technical-evaluation dossier Article 18 defines the technical evaluation information and evidence for devices that are not controlled technology biomedical equipment. | 2026-08-24 |
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