ERIS CircularCircular Informativa n.º 002/ERIS-CA/2025
Circular Informativa n.º 002/ERIS-CA/2025 is the official ERIS identifier for “Utilização de testes de diagnóstico rápido da malária”. Circular Informativa n.º 002/ERIS-CA/2025 is the official identifier ERIS uses for this instrument.
- Instrument
- Circular
- Full name
- Circular Informativa n.º 002/ERIS-CA/2025
- Category
- Vigilance
- Source publication
- Portuguese
- Readable HTML
- 1 language version
- Published
- 2025-04-30
- Effective
- —
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Utilização de testes de diagnóstico rápido da malária
Complete signed 3-page ERIS circular dated 30 April 2025 concerning malaria rapid diagnostic tests, classified as IVDs. Includes all recommendations to health professionals and the National Malaria Programme on faint positive lines, storage, retesting/reassessment, reporting, user training and manufacturer investigations, with delegation footnote. This is product-specific vigilance guidance; it does not establish general medical-device import procedures or modification approval timelines.
Circular Informativa n.º 002/ERIS-CA/2025 is the official identifier ERIS uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.