ARSA O03-P01-S03-DDM-G-002O03-P01-S03-DDM-G-002
Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.
O03-P01-S03-DDM-G-002 is the official ARSA identifier for “Guía de Etiquetado de Dispositivos Médicos”. O03-P01-S03-DDM-G-002 is the official identifier ARSA uses for this instrument.
- Instrument
- O03-P01-S03-DDM-G-002
- Full name
- O03-P01-S03-DDM-G-002
- Category
- Labeling
- Source publication
- Spanish
- 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.
Guía de Etiquetado de Dispositivos Médicos
ARSA guide marked “Publicación 2025” explaining medical-device and IVD labelling, packaging, supplemental labels, example labels and symbols. It cites Title XV and Article 84 of the device-control regulation, distinguishes manufacturer or holder labels from importer-prepared supplemental labels, and sets out Spanish-language, legibility and content conditions. The seventeen main-label content items retain their stated applicability conditions, including the IVD-use declaration for relevant diagnostic devices. Illustrative labels and IFUs demonstrate their particular product context; research-only and other health-interest products retain the guide’s separate descriptions. All 51 source pages were examined. The searchable selection contains guide-authored text and symbol captions on 47 pages, with unaltered original page figures; four decorative photo pages remain in the complete original inventory. Embedded example-label microprint is preserved graphically. Only publication year 2025 is printed; no exact publication or effective day is assigned. Current applicability and later revisions remain unverified.
O03-P01-S03-DDM-G-002 is the official identifier ARSA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.