COFEPRIS DocumentCOFEPRIS NOM-241-SSA1-2025 Q&A — version 1.0
Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.
Guía de preguntas y respuestas en materia de la NOM-241-SSA1-2025, Buenas Prácticas de Fabricación de Dispositivos Médicos is published by Comisión Federal para la Protección contra Riesgos Sanitarios. This document is identified by its title; no separate official document code is recorded.
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Guía de preguntas y respuestas en materia de la NOM-241-SSA1-2025, Buenas Prácticas de Fabricación de Dispositivos Médicos
Complete 19-page official COFEPRIS orienting questions-and-answers guide, printed version 1.0 dated 4 April 2025. Page 3 expressly identifies the guide as orienting. Its distinct manufacturer/BPF, primary/secondary conditioning, ISO 13485 equivalence and warehouse/overlabelling conditions remain scoped to their original questions; no universal product-change or ownership-transfer requirement is inferred. All original physical page images are mandatory and authoritative; exact native PDF text is only an incomplete search layer, omits the graphic cover wording and may contain table or extraction artifacts. The full original, glossary and bibliography are retained without alteration. This medical-device source is not final FEUM 5.0 Appendix III.3, III.3.8 or conditional Appendix IV and does not close those gaps or establish consolidated currentness. The printed version date is not treated as an effective date.
This document is identified by its title; no separate official document code is recorded. Always confirm the current consolidated text and transition provisions with the official source before filing.