ANVISA 80118011
Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.
8011 is 8011 8011. 8011 is the official identifier ANVISA uses for this instrument.
- Instrument
- 8011
- Full name
- 8011
- Category
- Registration
- Source publication
- Portuguese
- Readable HTML
- 1 language version
- Published
- —
- Effective
- —
Open a language version
Each version has stable passage anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.
Documentos de Instrução — 8011 - IVD – Alteração de registro – Implementação imediata – Fabricante legal do produto, sem alteração no processo fabril.
Complete official public checklist legal form, preserving its title, blank Área label, exact subject, all document requirements, legal basis, electronic-signature/IFU instructions and warning text in source order. Two presentation tables are explicitly unwrapped; only the independently captured and viewed warning-symbol icon and two final navigation rows are omitted. No publication/effectiveness date is stated. Legal-manufacturer change without manufacturing-process change. Preserve the additional prior-approval manufacturing-site filing where the replacement manufacturer is also the manufacturing unit.
8011 is the official identifier ANVISA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.