AGEMED NORMANORMA 2025-01
NORMA 2025-01 is the official AGEMED identifier for “Manual de Registro Sanitario de Dispositivos Médicos de Diagnóstico In Vitro”. NORMA 2025-01 is the official identifier AGEMED uses for this instrument.
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- NORMA
- Full name
- NORMA 2025-01
- Category
- Registration
- Authority source
- Spanish
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Manual de Registro Sanitario de Dispositivos Médicos de Diagnóstico In Vitro
Manual de Registro Sanitario de Dispositivos Médicos de Diagnóstico In Vitro (DMDIV) — the IVD counterpart to the devices Manual, and the instrument that states the in-vitro registration requirement in Bolivia. Four chapters: generalities, objective, scope and glossary (Chapter I); the registration requirements and the technical documentation (Chapter II); the labelling requirements, including the symbol set, as an annex; and the remaining annexes covering the label, the package insert and the assessment flow. ANEXO 1 in the source numbers its own headings inconsistently — `2.2 Para autoensayo` is a heading while `2.2 según proceda.` on another page is a cross-reference in running prose, and the same collision occurs at `3.1` — so only its three top-level headings are exposed as blocks and the numbered sub-items stay in the text of the heading they belong to. That is the document's own inconsistency, not an extraction choice; no text was moved or renumbered.
NORMA 2025-01 is the official identifier AGEMED uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.