Bolivia medical device regulations

Decreto Supremo N° 25235 de 30 de noviembre de 1998, reglamento to Ley N° 1737 (Ley del Medicamento), signed by Presidente Hugo Banzer Suárez in Consejo de Ministros. 151 articles across 22 chapters: the registration of medicamentos, the establishments authorised to handle them, control of import and export, prices, advertising and the inspection powers of the health authority, plus the additional, transitional and final provisions that carry its effectivity clause. It is the medicines instrument onto which Bolivia's device-specific regulation was later built, and it is the reason a device citation in Bolivia frequently has to reach through medicines law. The AGEMED copy is a republication carrying the AGEMED file code T-N-2 on its cover, which is why that code appears in the source URL. The document states no effective date separately from its date of issue.

Decreto Supremo N° 2905, issued by Presidente en Ejercicio Álvaro Marcelo García Linera in Consejo de Ministros. Eight articles create the Agencia Estatal de Medicamentos y Tecnologías en Salud (AGEMED) and define its object, its competences over medicamentos and tecnologías en salud — which is where medical devices sit — and its financing, followed by additional and transitional provisions. This is the instrument that gives AGEMED the authority every other Bolivian row on this page is issued under. The document states no publication or effective date in its own text, so no date is recorded here.

The activity flowchart for AGEMED's abbreviated and homologated registration route for UTI-COVID products — two summary tables, one for the COVID route as it applied to UTI products and one for the COVID route itself, each laying out the step sequence, the responsible unit and the time allowed at each step. It is the documentary evidence of how the emergency-era abbreviated route actually ran, and it is the only Bolivian row here that describes a procedural path rather than a requirement. The two tables are exposed as two blocks; their cell contents are preserved as the PDF lays them out, so the column structure reads across each table rather than per row.

FORM. 027 — the prescribed application form for registering a medical device or equipment in Bolivia, issued by the Estado Plurinacional de Bolivia, Ministerio de Salud. Four numbered sections (general particulars of the filing, the applicant company, the manufacturer, and the product) plus the signature block. It is the form an applicant actually fills in, so it is the authoritative list of the fields AGEMED requires. This file and ANEXO 1 of the devices Manual print the same form; the Manual row notes the overlap. The document states no publication date.

Form. 096, Versión 00 — the document checklist an applicant must satisfy to open a medical device importing establishment in Bolivia. Three requirement groups (documents for the company, documents for the Regente Farmacéutico or Responsable Técnico including the accepted professional profiles, and the warehouse verification against Buenas Prácticas de Almacenamiento), followed by the inscription fee set under Resolución Ministerial N° 265. The covering instruction requires the documents to be foliated from back to front in one folder, which is a requirement an applicant cannot infer from the list alone. The document states no publication date.

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.

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.

Resolución Administrativa N° 04, La Paz, 14 de marzo de 2024, issued by AGEMED, which approves the Lista Nacional de Dispositivos Médicos (LINADIME) for 2024–2026. Five articles: the approval of the list, its two year term of validity, the effect of that validity on registrations already granted, the limited use to which the list may be put, and the AGEMED unit responsible. Read against the Manual, it defines which devices AGEMED will register as listed and the window in which a listing is current. The PDF carries a noisy embedded OCR text layer whose accents are wrong in the official bytes; the text is ingested exactly as published, artefacts included.

Resolución Administrativa N° 20, La Paz, 18 de octubre de 2023, issued by AGEMED, which establishes the régimen técnico for reporting the prices of the devices and equipment it regulates. Four articles: the obligation and the reason it attaches to these product classes, the reporting form added to the "AGEMED VIRTUAL" platform, and the treatment of a virtual report as a registry entry for administrative purposes. This is a post-market obligation that falls on a registration holder, not an approval route. The PDF carries a noisy embedded OCR text layer; the cover is badly damaged and prints fragments of an unrelated letterhead above the resolution number. The text is ingested exactly as published, artefacts included.

Resolución Administrativa N° 42, La Paz, 18 de septiembre de 2024, issued by AGEMED, which approves the Principios Relativos para la Utilización de Decisiones Regulatorias de Otros Países (reliance). Three articles approve the principles and set their scope; the principles are carried as an annex in four parts — an introduction, the fundamental principles and elements, their use in practice, and a directive for using another authority's decision. This is the instrument behind Bolivia's reliance route, so it matters to a device applicant whose product is already cleared elsewhere. The PDF carries a noisy embedded OCR text layer: accents, ligatures and some letters are wrong in the official bytes themselves (for example the reliance section headings print "UTILIZACIóN" with a lowercase ó). The text is ingested exactly as the authority published it; occasional OCR artefacts are preserved rather than corrected, so a quotation copied from this corpus matches the file a reader will download.

Requisitos para Comercialización de Equipos Biomédicos — the checklist of documentation a legal representative of the manufacturer must deliver to the Departamento de Vigilancia y Control before commercialising biomedical equipment. Five numbered requirements: the application letter for the commercialisation certificate, proof of payment, the declaration under point 2.9 of the devices Manual, the information required by point 2.9.2 of the same Manual, and the operation, maintenance and installation manual required by point 2.7. It is a distinct instrument from the Manual chapter it cites: this is the post-registration commercialisation checklist, and the Manual is the registration procedure it cross-refers to. The file is short (a single form) and states no publication date.