AGEMED T-N-35T-N-35 / RM-00113-BGM
T-N-35 / RM-00113-BGM is the official AGEMED identifier for “Manual para Registro Sanitario de Dispositivos Médicos”. T-N-35 / RM-00113-BGM is the official identifier AGEMED uses for this instrument.
- Instrument
- T-N-35
- Full name
- T-N-35 / RM-00113-BGM
- Category
- Registration
- Authority source
- Spanish
- Readable HTML
- 0 articles · 1 language version
- Published
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Each version has stable article anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.
Manual para Registro Sanitario de Dispositivos Médicos
Manual para Registro Sanitario de Dispositivos Médicos — AGEMED's operational procedure for device registration, and the instrument that actually states the requirement in Bolivia. Chapter I carries the legal frame, the devices subject to registration, the definition and the classification rules; the middle chapters are the registration procedure itself; ANEXO 1 is the prescribed application form; ANEXO 2 is the device grouping table (15 non-invasive, 15 invasive and 4 active groups with their assigned risk). The file is an AGEMED re-publication, and neither the code T-N-35 / RM-00113-BGM nor the approving ministerial resolution appears anywhere in its own text — both come from the AGEMED registry listing, so the code is a registry identifier, not something the document calls itself. The document states no publication date. ANEXO 1 prints the FORM. 027 application form, which is also ingested as its own lead (`bolivia-form-027`) from a separate AGEMED file; the two are the same printed form reached through two official URLs, not two legal instruments, and a reader citing the form should expect to land on either.
T-N-35 / RM-00113-BGM is the official identifier AGEMED uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.