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AGEMED · structured requirements

🇧🇴 Bolivia IVD regulatory data

Explore the IVD requirements currently available for Bolivia, organized by topic and linked to official sources.

10 facts9 dimensions9 official sourceslatest verification 2026-09-16

Changes after registration

Explore questions and sources →

Common questions about changing a registered IVD in Bolivia. Each question separates published rules from details still awaiting verification.

Authority & regime

Which authority and binding regime govern this product, task, and date?

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AGEMED's statutory functions cover evaluation, authorisation and post-market control of health technologies

authority.agemed-device-registration-competence
Fact-level verified
Statement

AGEMED's statutory functions include issuing prior import authorisations and company-opening authorisations, issuing technical procedures, evaluating, authorising, regulating, controlling and inspecting the production, import, storage, distribution, marketing and prices of medicines and health technologies, evaluating their safety, efficacy and quality, issuing marketing authorisations through sanitary registrations, inspecting and auditing manufacturers, importers and wholesalers, and running pharmacovigilance, technovigilance and haemovigilance programmes.

Article

Art. 7(c), (d), (e), (f), (g)

Conditions
  • The functions are drafted for 'medicamentos y tecnologías en salud'; medical devices fall within 'tecnologías en salud'.
  • 'Tecnovigilancia' is named as an AGEMED programme, which is the legal hook for device post-market surveillance.

Effective from 2016-09-21

Source language: Spanish. English translation of Art. 7(c): 'To evaluate, authorise, regulate, monitor, control and inspect the production, manufacture, import, export, storage, distribution, transport, commercialisation, promotion, advertising, prescription, dispensing and prices of medicines and health technologies.' Art. 7(e): 'To issue marketing authorisations through sanitary registrations and other authorisations, for the use of medicines and health technologies.'

AGEMED is the national regulatory authority, a decentralised public body of the Ministry of Health

authority.agemed-nature-and-creation
Fact-level verified
Statement

AGEMED (Agencia Estatal de Medicamentos y Tecnologías en Salud) was created by Decreto Supremo N° 2905 of 21 September 2016 on the basis of UNIMED and the CONCAMYT quality-control laboratory, and is a public institution decentralised from the Ministry of Health with independence of administrative, financial, legal and technical management. It is responsible for regulating the activities of natural and legal persons in the field of medicines and health technologies, which includes medical devices.

Article

Art. 3; Art. 2

Conditions
  • Before 2016 the device registration function was exercised by the Dirección de Medicamentos y Tecnología en Salud (DINAMED); the 2006 device manual still names DINAMED because it predates AGEMED.
  • AGEMED is 'desconcentrada' (decentralised under the ministry), not an independent agency.

Effective from 2016-09-21

Source language: Spanish. English translation: 'Article 3 (Legal nature). AGEMED is a public institution decentralised from the Ministry of Health, with independence of administrative, financial, legal and technical management.' Article 2(I) adds that AGEMED is 'responsible for regulating the activities carried out by natural and legal persons, private, community, public, mixed and cooperative, in the sector of medicines and health technologies.'

Device definition & scope

Is the product a device, IVD, accessory, software, or borderline product locally?

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Bolivian medical-device definition, including IVD examination of body-derived samples

scope.device-definition
Fact-level verified
Statement

Bolivia defines a medical device, in the framework of DS 25235 Article 5 and the WHO/PAHO glossary, as any instrument, apparatus, implement, machine, contrivance, implant, material or other similar or related article, used alone or in combination, including accessories and software necessary for its correct application as proposed by the manufacturer, on human beings for diagnosis, prevention, monitoring, treatment or alleviation of disease or injury, investigation, replacement or support of anatomical structure or physiological process, support or sustaining of life, control of conception, disinfection of medical devices, or in-vitro examination of samples derived from the human body, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means but may be assisted in its function by such means.

Article

Numeral 1.6

Conditions
  • The definition expressly includes in-vitro examination of samples derived from the human body, so IVDs are within the device definition as well as under Ley 1737 Art. 4(g).
  • Registered 'insumos', miscellaneous and dental products falling within the definition are reclassified into the medical-device category.

Source language: Spanish. English translation of the final limb: '...in-vitro examination of samples derived from the human body, and which does not fulfil its basic intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its functions by such means.'

Fees

What regulator fee applies to this class, route, event, and date?

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Registration service tariffs for devices, prostheses and diagnostic reagents

fees.device-registration-tariffs
Fact-level verified
Statement

The AGEMED fee schedule for registration services sets, among others: imported medical device, registration inscription 1.489; national medical device, inscription 993; national medical device, reinscription 745; imported diagnostic reagent, inscription 1.241; imported prosthesis or implant, inscription 1.737; national prosthesis or implant, inscription 869; and a second evaluation of a registration dossier, 621. Amounts are in bolivianos (Bs).

Article

Items 82-99 and 102

Conditions
  • Amounts read directly from the scanned schedule; item 83 (Dispositivo médico importado, Reinscripción) is Bs 1.117 and is legible.
  • A second-evaluation fee (item 102) applies where a rejected or observed dossier re-enters evaluation.
  • Payment for registration evaluation is made by bank deposit to the Banco Central de Bolivia into the account of the Ministry of Health and Sports (manual numeral 2.8(a)).

Source language: Spanish (scanned image PDF, read via OCR). Status is source-backed-partial because the schedule is a scan and the row values were recovered by OCR; the currency (Bs) is confirmed by the separately read Form 096, which states 'Bs.- 4.964.' for an AGEMED service. The approving resolution number stamped on the schedule could not be read reliably and is not asserted.

Manufacturer PMS

Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?

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Reference-price and monthly stock reporting for medicines, vaccines, medical devices, diagnostic reagents and medical equipment

pms.price-and-stock-reporting-including-devices
Fact-level verified
Statement

AGEMED established a technical-administrative reporting regime whose chapeau expressly covers 'medicamentos, vacunas, dispositivos médicos, reactivos de diagnóstico y equipos médicos'. Under it, every industrial laboratory, importer or national distributor must report referral prices by distribution channel five (5) working days before the start of commercialisation or a price change (literal a); a monthly stock report is established only for the medicines included in the current Lista Nacional de Medicamentos Esenciales, filed within five (5) working days after the end of the month (literal b); both reports are made exclusively through the 'AGEMED VIRTUAL' platform (literal c); any change to that platform is socialised by AGEMED by circular with a 30-working-day implementation period (literal d); and every such virtual report and registration is a sworn declaration (Artículo Cuarto).

Article

Artículo Primero (a)-(d) and Artículo Cuarto

Conditions
  • The monthly stock-reporting duty in literal (b) is on its face limited to 'medicamentos incluidos en la Lista Nacional de Medicamentos Esenciales vigente'; it is the referral-price duty in literal (a), together with the chapeau's product scope, that reach medical devices, diagnostic reagents and medical equipment.
  • Artículo Segundo provides a separate stock-reporting form for oxygen (LINAME code V0310) and liquid/cryogenic oxygen, and repeats the monthly import/production and distribution reporting through 'AGEMED VIRTUAL' within five working days after the end of the month.
  • Artículo Tercero requires an 'AGEMED VIRTUAL' format for registering products protected by a Bolivian patent and their expiry date.
  • The resolution's VISTOS record that it implements art. 148 of DS 25235 and art. 11 of DS 26873 (referral prices, five days in advance) and that AGEMED's functions under art. 7(c) of DS 2905 include evaluating, authorising, regulating, policing and inspecting the 'promoción, publicidad ... y precios de medicamentos y tecnologías en salud'.
  • The instrument is issued by AGEMED and its scope chapeau names devices directly, so no reliance on the Ley 1737 art. 4(g) 'medicamentos especiales' chain is needed for this fact.

Effective from 2023-10-18

AGEMED — Regulación farmacéutica: índice de normativa nacional, con indicación de vigencia (Resoluciones Administrativas, Ministeriales, Decretos Supremos, Leyes)

Source language: Spanish. Status raised from source-backed-partial to official-source-verified on 2026-09-16. TRANSPARENCY ON THE TEXT LAYER: the published PDF is four 300-dpi page images (producer 'iLovePDF') carrying a non-embedded Helvetica OCR text layer supplied by the publisher; no OCR was performed by this research. The layer carries visible slips, preserved verbatim in the excerpt above, in 'Sera' (for 'Será') and 'Ios' (for 'los'), and the header lines of pages 1 and 3 extract as scan noise. The chapeau's device-inclusive scope was independently corroborated against AGEMED's own normativa index, which lists this resolution as 'RESOLUCIÓN ADMINISTRATIVA N° 020 ... se establece el régimen técnico administrativo para medicamentos, vacunas, dispositivos médicos, reactivos de diagnóstico y equipos médicos, 18/10/2023'. The operative literal (b) limiting monthly stock reporting to LINAME medicines is quoted because the earlier partial row described the stock duty as covering 'the products covered', which over-read the text; the value above now states the limit.

Registration pathways

Which registration, notification, listing, reliance, or conformity route applies?

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Prior Registro Sanitario is mandatory for every device placed on the market

pathway.registro-sanitario-mandatory-before-marketing
Fact-level verified
Statement

Every product to be manufactured, imported, exported, acquired, distributed, marketed, prescribed and dispensed in Bolivia must previously hold a Registro Sanitario granted indelegably; Article 10 defines the Registro Sanitario as the procedure by which a pharmaceutical product passes through a strict pre-marketing evaluation.

Article

Art. 11

Conditions
  • The article says 'todo producto'; the device manual applies it to medical devices through the Ley 1737 definition and through numeral 1.5, which lists the modalities requiring a Registro Sanitario.
  • There is one registration per group of devices, not per model (device manual numeral 2).

Effective from 1998-11-30

Source language: Spanish. English translation: 'Every product to be manufactured, imported, exported, acquired, distributed, marketed, prescribed and dispensed in the country must previously hold a Registro Sanitario granted indelegably by the Ministry of Health and Social Welfare.'

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

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Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Bolivia approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Bolivia (5 records)

BoliviaUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority

FDA 510(k)/PMA

Accepted

No

Benefit

No Bolivian instrument names the FDA or any individual foreign regulator as a basis for a shortened device registration; an FDA clearance is neither market access nor a substitute for the Registro Sanitario, and it is used only as evidence in the dossier.

Manual para Registro Sanitario de Dispositivos Médicos, aprobado por Resolución Ministerial N° 10 de 17 de enero de 2006, numerales 2.3.3, 3.1.4 y 3.1.5 — reinscripción, observaciones y entrega del Certificado de Registro SanitarioManual de Registro Sanitario de Dispositivos Médicos de Diagnóstico In Vitro, published on agemed.gob.bo as NORMA-2025-01, Capítulo III §1.6 PLAZOS NORMATIVOS — §1.6.1 Inscripción y Reinscripción, §1.6.2 Rectificación and §1.6.3 RechazoCircular AGEMED N° 86/2023, numeral 4 — plazo para la emisión de Certificados de Comercialización de equipos biomédicosResolución Administrativa AGEMED N° 42/2024, Directriz anexa, numerales 2 y 4.5 — alcance y plazos del procedimiento de relianceCircular MSyD/AGEMED/CR/63/2024 — disposiciones relativas a los procesos de reinscripción; identifica el Manual para Registro Sanitario de Dispositivos Médicos como aprobado por Resolución Ministerial N° 10 de 17 de enero de 2006 y su numeral 2.3.3 como requisito de reinscripción

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

BoliviaEU conformity assessment

Prior approval / evidence record

EU CE marking

Authority

EU CE marking

Accepted

No

Benefit

No named-approval fast track exists. A CE certificate or ISO 13485 certificate is accepted as the quality-system evidence of numeral 2.3.1 of the device manual, not as an authorisation.

Manual para Registro Sanitario de Dispositivos Médicos, aprobado por Resolución Ministerial N° 10 de 17 de enero de 2006, numerales 2.3.3, 3.1.4 y 3.1.5 — reinscripción, observaciones y entrega del Certificado de Registro SanitarioManual de Registro Sanitario de Dispositivos Médicos de Diagnóstico In Vitro, published on agemed.gob.bo as NORMA-2025-01, Capítulo III §1.6 PLAZOS NORMATIVOS — §1.6.1 Inscripción y Reinscripción, §1.6.2 Rectificación and §1.6.3 RechazoCircular AGEMED N° 86/2023, numeral 4 — plazo para la emisión de Certificados de Comercialización de equipos biomédicosResolución Administrativa AGEMED N° 42/2024, Directriz anexa, numerales 2 y 4.5 — alcance y plazos del procedimiento de relianceCircular MSyD/AGEMED/CR/63/2024 — disposiciones relativas a los procesos de reinscripción; identifica el Manual para Registro Sanitario de Dispositivos Médicos como aprobado por Resolución Ministerial N° 10 de 17 de enero de 2006 y su numeral 2.3.3 como requisito de reinscripción

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

BoliviaSource authority not specified

Prior approval / evidence record

Reliance sobre decisiones regulatorias de otros países

Name

Reliance sobre decisiones regulatorias de otros países

Description

Resolución Administrativa AGEMED N° 42/2024 approves the principles for using other countries' regulatory decisions and an annexed directive that admits a current foreign registration from a recognised reference authority as the input to a Bolivian inscription, with a 2-month technical documentary analysis and 1 month for renewal or rectification.

Timeline Reduction

Shorter documentary analysis, with no published period for the ordinary route to compare against

Eligibility
  • Product within the directive's scope, which expressly names dispositivos médicos and dispositivos de diagnóstico in vitro
  • Current registration or marketing authorisation from at least one reference authority recognised by law or by PAHO/WHO listing
  • Sworn declaration of equivalence filed by the applicant; AGEMED retains the decision
Manual para Registro Sanitario de Dispositivos Médicos, aprobado por Resolución Ministerial N° 10 de 17 de enero de 2006, numerales 2.3.3, 3.1.4 y 3.1.5 — reinscripción, observaciones y entrega del Certificado de Registro SanitarioManual de Registro Sanitario de Dispositivos Médicos de Diagnóstico In Vitro, published on agemed.gob.bo as NORMA-2025-01, Capítulo III §1.6 PLAZOS NORMATIVOS — §1.6.1 Inscripción y Reinscripción, §1.6.2 Rectificación and §1.6.3 RechazoCircular AGEMED N° 86/2023, numeral 4 — plazo para la emisión de Certificados de Comercialización de equipos biomédicosResolución Administrativa AGEMED N° 42/2024, Directriz anexa, numerales 2 y 4.5 — alcance y plazos del procedimiento de relianceCircular MSyD/AGEMED/CR/63/2024 — disposiciones relativas a los procesos de reinscripción; identifica el Manual para Registro Sanitario de Dispositivos Médicos como aprobado por Resolución Ministerial N° 10 de 17 de enero de 2006 y su numeral 2.3.3 como requisito de reinscripción

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

BoliviaWHO

Prior approval / evidence record

PAHO/WHO reference authority or WHO-listed authority registration

Authority

PAHO/WHO reference authority or WHO-listed authority registration

Accepted

Yes

Benefit

Admissible under the reliance directive annexed to Resolución Administrativa AGEMED N° 42/2024 as the input to an inscription with a 2-month documentary analysis, subject to a sworn declaration of equivalence.

Manual para Registro Sanitario de Dispositivos Médicos, aprobado por Resolución Ministerial N° 10 de 17 de enero de 2006, numerales 2.3.3, 3.1.4 y 3.1.5 — reinscripción, observaciones y entrega del Certificado de Registro SanitarioManual de Registro Sanitario de Dispositivos Médicos de Diagnóstico In Vitro, published on agemed.gob.bo as NORMA-2025-01, Capítulo III §1.6 PLAZOS NORMATIVOS — §1.6.1 Inscripción y Reinscripción, §1.6.2 Rectificación and §1.6.3 RechazoCircular AGEMED N° 86/2023, numeral 4 — plazo para la emisión de Certificados de Comercialización de equipos biomédicosResolución Administrativa AGEMED N° 42/2024, Directriz anexa, numerales 2 y 4.5 — alcance y plazos del procedimiento de relianceCircular MSyD/AGEMED/CR/63/2024 — disposiciones relativas a los procesos de reinscripción; identifica el Manual para Registro Sanitario de Dispositivos Médicos como aprobado por Resolución Ministerial N° 10 de 17 de enero de 2006 y su numeral 2.3.3 como requisito de reinscripción

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

BoliviaWHO

Prior approval / evidence record

Use of another country's regulatory decision under the AGEMED reliance directive (RA 42/2024)

reliance.who-listed-authority-reference-decision-directive
Fact-level verified
Statement

AGEMED's Resolución Administrativa N° 42 of 18 September 2024 approved the 'Principios relativos para la utilización de decisiones regulatorias de otros países — Reliance (Confianza)' and its attached directive for inscription, renewal and rectification of marketing authorisations. The directive's scope clause names 'dispositivos médicos' and 'dispositivos de diagnóstico in vitro' among the products it applies to, so a foreign regulatory decision is an admissible input for a Bolivian device registration. Eligibility requires the device to hold a current registration/marketing authorisation from at least one reference authority, and the reference authority must be one recognised by law, a PAHO/OPS reference authority, or a WHO Listed Authority (WLA) for the regulatory function 'registration and marketing authorisation'. For devices the documentary proof of the reference decision is a sworn declaration of equivalence in which the importer or responsible party declares the device to be identical to the one authorised by the reference regulator. AGEMED states expressly that the procedure does not imply automatic acceptance of the reference authority's evaluation and that it retains its independence and sovereignty over the decision.

Source Approval

Any authority on the WHO Listed Authorities (WLA) list or the PAHO/OPS reference-authority list for the regulatory function 'registration and marketing authorisation' (the resolution names no authority individually; US FDA, EU/CE, Japan PMDA and Korea MFDS are not named)

Edge Type

Abridged Or Recognition Route

Market Access Strength

facilitated

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Devices are named only in the scope clause (numeral 2). The operative eligibility clause (numeral 4.1) says 'trámites de autorización de comercialización de inscripción, reinscripción y rectificación de medicamentos', and the reference-authority clause (numeral 4.3) says 'para medicamentos y vacunas', so device eligibility is expressly listed but is not unambiguously operationalised in the procedure itself.
  • AGEMED's own circular publicising the resolution, MSyD/AGEMED/CR/48/2024 of 19 September 2024, is addressed to 'Importadoras de Medicamentos reconocidos por Ley'.
  • Numeral 4.2 requires the full set of technical and administrative documents demanded by current Bolivian pharmaceutical regulation, in addition to the reference-decision evidence; the reference decision does not replace the local dossier.
  • Numeral 4.4: 'La utilización del presente procedimiento no implica la aceptación automática por la AGEMED de los resultados de la evaluación regulatoria de la autoridad de referencia. La AGEMED conserva su independencia y soberanía en la toma de decisiones.'
  • Stated analysis periods (numeral 4.5): 2 months for inscription, 1 month for renewal or rectification, against 30 working days for delivery of the ordinary device registration certificate under numeral 3.1.5 of the device manual.
  • Excludes inscription of new molecules or new indications.
  • Entry into force: 'a partir del día siguiente hábil al de su publicación' on the AGEMED website (Artículo Tercero); the publication date on the AGEMED site could not be established, so no effectiveFrom is asserted.

Source language: Spanish. The PDF carries an OCR text layer in which diacritics are frequently mangled (e.g. 'InscripciOn' for 'Inscripción'); the excerpt reproduces the extracted characters. English translation of the excerpt: 'This Directive applies to the services of Inscription, Renewal and Rectification of the Marketing Authorisations issued by AGEMED for the following products: generic medicines, brand-name medicines, special medicines, biologicals, blood derivatives and radiopharmaceuticals, medical devices, in-vitro diagnostic devices. Excepting the inscription of new molecules or new indications of the products mentioned.'

Special access & derogation

Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?

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COVID-19 emergency abridged and homologated registration procedure (Registro Abreviado y Homologado)

special-access.covid-abridged-homologated-registration
Fact-level verified
Statement

AGEMED published, and operated during Bolivia's COVID-19 health emergency, an 'Obtención de Registro Abreviado y Homologado' procedure, set out as two summary flow-chart tables. For 'productos UTI - COVID' the whole procedure was clocked at a 15-hour total, and for 'productos COVID' at 10 days. Both run the same six steps: reception of the file through the MISA platform with generation of an invoice and a routing sheet (maximum 2 hours after the company sends the request); evaluation by the professional evaluator of the authorisation department, with the file either approved, observed (the company remedies the observation and re-enters evaluation) or rejected; printing of the Registro Sanitario; issuance of the certificate with the signatures of the head of the authorisation department and of AGEMED's Director General Executive (maximum 4 hours); digitisation of the certificate (maximum 2 hours after issuance); and delivery of the certificate at the counter (1 hour after digitisation), with the file archived by AGEMED and CONCAMYT. A 'reingreso con pago de 2° evaluación' step applies where the file was observed.

Article

Tabla resumen, both tables

Conditions
  • The procedure is headed expressly for UTI-COVID and COVID products; it was an emergency-period derogation, not a general reliance or abridged route for devices. Bolivia's general recognition instrument is RA 42/2024 (see the reliance-recognition facts).
  • The enabling resolution was Resolución Administrativa N° 043 of 30 December 2021 ('Aprueba el procedimiento y requisitos para la evaluación de solicitudes de Registro Sanitario Homologado y Abreviado en el marco de la Resolución Ministerial No. 0550'), which AGEMED's own normativa index records as '(NO VIGENTE)'. The resolution itself is published only as an image-only scan (6 pages, no embedded fonts) and was not OCR'd.
  • The emergency period has ended: AGEMED's normativa index records 'RESOLUCIÓN ADMINISTRATIVA N° 017 — Se levanta la Declaración de Emergencia Sanitaria Nacional Contra la COVID-19, 18/08/2023'.
  • No separate resolution approving this particular flow chart was located, and the flow chart is undated; the document is nevertheless the regulator's own published procedure and is machine-readable in full, including both total rows.
AGEMED — Regulación farmacéutica: índice de normativa nacional, con indicación de vigencia (Resoluciones Administrativas, Ministeriales, Decretos Supremos, Leyes)

Source language: Spanish. Status raised from source-backed-partial to official-source-verified on 2026-09-16: the earlier partial row rested on the same table but its text had not been read and its standing had not been confirmed. The document extracts cleanly as text, so the table is now quoted verbatim, and the regulator's own normativa index supplies the standing of the enabling resolution and of the emergency declaration. The AGEMED normativa index is named as a supporting source because it, and not the unreadable RA 043/2021, establishes the force status of the enabling resolution and the lifting of the emergency.

Submission communications & appeal

How are deficiencies answered, clocks handled, and decisions escalated or appealed?

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A rejected applicant may file a recurso de reconsideración within 15 working days

appeal.reconsideration-within-15-working-days
Fact-level verified
Statement

Where the unit responsible for registration does not approve the product, it notifies the interested party, who has the right to file a recurso de reconsideración within the following 15 working days. The notification states the grounds for non-approval.

Article

Art. 17

Conditions
  • This is the statutory appeal route in DS 25235; the device manual adds an administrative appeal of its own in numeral 5.4 (Rechazo de Productos): an applicant who does not accept the rejection may take it to the Comité de Garantía de Calidad as the appeal instance, filing a report with the technical justification signed by the regent or technical responsible and the legal representative.
  • AGEMED administrative acts generally follow Ley N° 2341 de Procedimiento Administrativo, which RA 42/2024 cites for the essential elements of an administrative act.

Effective from 1998-11-30

Source language: Spanish. English translation: 'Article 17.- Where the Unit of Medicines and Laboratories does not approve the product, it shall notify the interested party, who shall have the right to file a reconsideration appeal within the following fifteen (15) working days. This notification shall state the grounds for non-approval.'

Related structured datasets

Classification systems · 0 records

No maintained record.

Registration pathways, prior approvals and planning · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Bolivia registration →
Country

Bolivia

Jurisdiction Id

bolivia

Country Code

BO

Flag

🇧🇴

Regulator

Agencia Estatal de Medicamentos y Tecnologías en Salud

Regulator Abbrev

AGEMED

Region

americas

Tier

3

Risk Classification

4-class (I, IIa, IIb, III) — GHTF classification rules in numeral 1.7.2 of the Manual para Registro Sanitario de Dispositivos Médicos

Classes
  • Id

    registro-sanitario-inscription

    Class Name

    Clases I, IIa, IIb y III — inscripción del Registro Sanitario

    Risk Level

    high

    Pathway

    Dossier filed on Formulario 027 with the legal-administrative, quality-system and technical requirements of numerals 2.1 to 2.8 of the device manual; the Certificado de Registro Sanitario is delivered for five years

    Official Timeline
    Min

    30

    Max

    30

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    Manual para Registro Sanitario de Dispositivos Médicos, aprobado por Resolución Ministerial N° 10 de 17 de enero de 2006, numerales 2.3.3, 3.1.4 y 3.1.5 — reinscripción, observaciones y entrega del Certificado de Registro Sanitario

    Url

    https://www.agemed.gob.bo/reg-far/doc_reg_far/T-N-35-RM-00113-BGM.pdf

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    4

    Max

    9

    Notes
    • Numeral 3.1.5 fixes 30 working days from entry of the dossier to the Dirección de Medicamentos y Tecnología en Salud for delivery of the original Registro Sanitario certificate, which is valid for five years.
    • This is a certificate-delivery period, not a substantive review clock: the manual fixes no separate evaluation deadline, and numerals 3.1.4(b) and (c) run before it — an observed dossier gets a written note that must be remedied within 60 calendar days, with one re-entry allowed within 60 days on payment of the second-evaluation tariff.
    • Numeral 2.6 requires samples only for low-risk devices; for moderate, moderate-high and high-risk devices samples are not part of the dossier, which is why the realistic range is longer for the higher classes.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

  • Id

    biomedical-equipment-commercialisation-certificate

    Class Name

    Equipos biomédicos — Certificado de Comercialización

    Risk Level

    medium

    Pathway

    Certificate issued on the manufacturer's or Bolivian representative's declaration (manual numeral 2.9), applied for through the MISA platform on payment of item 138 of RM 0265/2018; under manual numeral 2.9.2 it is the interim document that authorises commercialisation of biomedical equipment pending a specific equipment registration norm, one certificate per model and per institution, accessories requiring their own device Registro Sanitario (Circular 86/2023 numerals 7 and 13)

    Official Timeline
    Min

    5

    Max

    5

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    Circular AGEMED N° 86/2023, numeral 4 — plazo para la emisión de Certificados de Comercialización de equipos biomédicos

    Url

    https://www.agemed.gob.bo/circulares/2023/CIRCULAR-86-2023.pdf

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    1

    Max

    2

    Notes
    • Circular AGEMED N° 86/2023 numeral 4 states that, once the procedure has entered through the MISA platform, the time established for issuing Certificados de Comercialización for biomedical equipment does not exceed 5 working days.
    • Numeral 6: observations must be remedied within 5 working days or the file is archived without refund; numeral 12: the certificates have no specific validity until a new norm is issued.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    No

  • Id

    reliance-route-inscription

    Class Name

    Inscripción por reliance — decisión regulatoria de una autoridad de referencia

    Risk Level

    medium

    Pathway

    Registration under the reliance directive annexed to Resolución Administrativa AGEMED N° 42/2024, using a current foreign registration or marketing authorisation from a reference authority as an admissible input

    Official Timeline
    Min

    2

    Max

    2

    Unit

    months

    Verification Status

    official-verified

    Official Source
    Title

    Resolución Administrativa AGEMED N° 42/2024, Directriz anexa, numerales 2 y 4.5 — alcance y plazos del procedimiento de reliance

    Url

    https://www.agemed.gob.bo/resoluciones/RA_042_2024.pdf

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    3

    Max

    6

    Notes
    • Numeral 4.5 of the annexed directive fixes 2 months for the technical documentary analysis of an inscription once the application and the other pertinent documents are submitted.
    • TEXT-LAYER DISCLOSURE: the AGEMED-hosted PDF of RA 42/2024 has no digital text layer of its own. Its only extractable text is the publisher's own embedded text layer (Producer 'OmniPageCSDK19', Creator 'HP Smart Document Scan Software 3.80'), which this repository ingests as published; no OCR was run to read it. That layer systematically substitutes 'a' for 'o' — the raw text reads 'Renavacián a Rectificación de Registras Sanitarias' where the instrument says 'Renovación o Rectificación de Registros Sanitarios'. The period is unaffected by the substitution, but anyone re-verifying these figures should read the image directly. The device manual's own 30-working-day clock is a digital text layer and carries no such caveat.
    • The directive's scope clause (numeral 2) names 'dispositivos médicos' and 'dispositivos de diagnóstico in vitro' among the products it applies to, so a foreign regulatory decision is an admissible input for a Bolivian device registration; the periods themselves are drafted in medicines terms and AGEMED retains sovereignty over the decision.
    • Eligibility requires a current registration or marketing authorisation from at least one reference authority recognised by law, a PAHO/WHO listed authority being the reference set, and a sworn declaration of equivalence.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

  • Id

    reliance-route-renewal-or-rectification

    Class Name

    Renovación o rectificación por reliance

    Risk Level

    medium

    Pathway

    Renewal or rectification processed under the reliance directive annexed to Resolución Administrativa AGEMED N° 42/2024

    Official Timeline
    Min

    1

    Max

    1

    Unit

    months

    Verification Status

    official-verified

    Official Source
    Title

    Resolución Administrativa AGEMED N° 42/2024, Directriz anexa, numerales 2 y 4.5 — alcance y plazos del procedimiento de reliance

    Url

    https://www.agemed.gob.bo/resoluciones/RA_042_2024.pdf

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    1

    Max

    3

    Notes
    • Numeral 4.5 fixes 1 month for renewal or rectification under the reliance route, half the inscription period.
    • Same instrument and same embedded-text-layer disclosure as the reliance-inscription row above: the period was read from the publisher's own embedded text layer, not from a digital text layer and not by OCR.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    No

  • Id

    reinscription

    Class Name

    Reinscripción del Registro Sanitario a los cinco años

    Risk Level

    medium

    Pathway

    Reinscription following the same procedure as inscription except for the requirements expressly indicated, filed within the three months before expiry

    Official Timeline
    Min

    30

    Max

    30

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    Manual para Registro Sanitario de Dispositivos Médicos, aprobado por Resolución Ministerial N° 10 de 17 de enero de 2006, numerales 2.3.3, 3.1.4 y 3.1.5 — reinscripción, observaciones y entrega del Certificado de Registro Sanitario

    Url

    https://www.agemed.gob.bo/reg-far/doc_reg_far/T-N-35-RM-00113-BGM.pdf

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    2

    Max

    6

    Notes
    • THIS ROW OVERTURNS ITS OWN EARLIER VERIFIED NEGATIVE. It previously carried no officialTimeline, on the reading that the manual fixes no period for reinscription. The manual says the opposite on its face: the Chapter III heading is 'PROCEDIMIENTOS PARA REGISTRO SANITARIO DE DISPOSITIVO MÉDICO / 3.1. PROCEDIMIENTO PARA INSCRIPCIÓN O REINSCRIPCIÓN DE DISPOSITIVOS MÉDICOS', and numeral 3.1.7 states 'El procedimiento a seguir para el caso de reinscripciones se procederá de igual manera que para la inscripción a excepción de aquellos requisitos expresamente señalados' — the exception carved out is to the requirements, not to the periods. Numeral 3.1.5's 30-working-day delivery clock, running from the date the file enters the Dirección de Medicamentos y Tecnología en Salud, therefore covers reinscription.
    • The IVD manual states it in terms: NORMA-2025-01 §1.6.1 is headed 'Inscripción y Reinscripción: La AGEMED, emitirá un dictamen en un plazo de 30 días hábiles a partir de la fecha de la solicitud'. The same drafting pattern appears in the medicines regulation, D.S. 25235 Art. 24 ('La reinscripción de medicamentos seguirá el mismo procedimiento de la [inscripción]').
    • The filing window and the late-filing tolerance are applicant-facing and are not part of the clock: numeral 3.1.7 asks for the trámite 'en lo posible dentro de los tres meses antes de la caducidad', numeral 2.3.3(a) tolerates a filing up to 30 working days after expiry as still a reinscription, and numeral 3.1.7's second paragraph makes a filing up to 30 calendar days after expiry pay the inscription tariff.
    • Circular AGEMED N° 63/2024 quotes the manual's numeral 2.3.3 as the reinscription requirement, but this round could not read it — it is published only as a one-page image-only scan with no text layer — so that corroboration is unconfirmed and the manual text alone carries the clock.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

Expedited Pathways
  • Name

    Reliance sobre decisiones regulatorias de otros países

    Description

    Resolución Administrativa AGEMED N° 42/2024 approves the principles for using other countries' regulatory decisions and an annexed directive that admits a current foreign registration from a recognised reference authority as the input to a Bolivian inscription, with a 2-month technical documentary analysis and 1 month for renewal or rectification.

    Timeline Reduction

    Shorter documentary analysis, with no published period for the ordinary route to compare against

    Eligibility
    • Product within the directive's scope, which expressly names dispositivos médicos and dispositivos de diagnóstico in vitro
    • Current registration or marketing authorisation from at least one reference authority recognised by law or by PAHO/WHO listing
    • Sworn declaration of equivalence filed by the applicant; AGEMED retains the decision
Prior Approvals
  • Authority

    FDA 510(k)/PMA

    Accepted

    No

    Benefit

    No Bolivian instrument names the FDA or any individual foreign regulator as a basis for a shortened device registration; an FDA clearance is neither market access nor a substitute for the Registro Sanitario, and it is used only as evidence in the dossier.

  • Authority

    EU CE marking

    Accepted

    No

    Benefit

    No named-approval fast track exists. A CE certificate or ISO 13485 certificate is accepted as the quality-system evidence of numeral 2.3.1 of the device manual, not as an authorisation.

  • Authority

    PAHO/WHO reference authority or WHO-listed authority registration

    Accepted

    Yes

    Benefit

    Admissible under the reliance directive annexed to Resolución Administrativa AGEMED N° 42/2024 as the input to an inscription with a 2-month documentary analysis, subject to a sworn declaration of equivalence.

Key Requirements
  • File the application on Formulario 027 through the MISA platform, with the legal-administrative requirements of numeral 2.2 of the Manual para Registro Sanitario de Dispositivos Médicos.
  • Hold a quality-system certificate — Good Manufacturing Practices or its equivalent — that is no older than two years, legalised where it originates abroad (numeral 2.3.1).
  • For an imported device, file the certificate of free sale issued by the competent health authority of the country of origin, legalised by a Bolivian consulate or, failing consular representation, certified by the Ministry of Foreign Affairs (numeral 2.3.2).
  • Accredit a legal representative before the Área de Vigilancia y Control de AGEMED before filing; a foreign manufacturer cannot hold the registration directly (numeral 2.3.4).
  • File Spanish-language labelling and the technical or user manual in Spanish at the time of registration (numerales 2.5.1 and 2.7).
  • Remedy any observation within 60 calendar days of notification, with one re-entry allowed on payment of the second-evaluation tariff (numerales 3.1.4(b)-(c)).
  • Reinscribe within the three months before the five-year expiry, filing a copy of the previous Registro Sanitario as numeral 2.3.3 of the device manual requires (numeral 2.3.3(a), identified as such by Circular AGEMED N° 63/2024).
Local Rep Required

Yes

Local Rep Name

Representante legal del fabricante extranjero, acreditado ante el Área de Vigilancia y Control de AGEMED antes de presentar la solicitud (numeral 2.3.4 del Manual)

Mdsap Accepted

No

Mdsap Benefit

MDSAP is not recognised. The dossier requires a Good Manufacturing Practices certificate or its equivalent that is no older than two years (numeral 2.3.1), and AGEMED may require in-situ verification of the plant at any time.

Registration Validity

5 years for a device, reagent, prosthesis or implant Registro Sanitario (numeral 3.1.5 del Manual), renewable by reinscripción

Last Updated

2026-09-16

Verification Status

official-verified

Official Sources
  • Title

    Manual para Registro Sanitario de Dispositivos Médicos, aprobado por Resolución Ministerial N° 10 de 17 de enero de 2006, numerales 2.3.3, 3.1.4 y 3.1.5 — reinscripción, observaciones y entrega del Certificado de Registro Sanitario

    Url

    https://www.agemed.gob.bo/reg-far/doc_reg_far/T-N-35-RM-00113-BGM.pdf

    Accessed Date

    2026-09-16

  • Title

    Manual de Registro Sanitario de Dispositivos Médicos de Diagnóstico In Vitro, published on agemed.gob.bo as NORMA-2025-01, Capítulo III §1.6 PLAZOS NORMATIVOS — §1.6.1 Inscripción y Reinscripción, §1.6.2 Rectificación and §1.6.3 Rechazo

    Url

    https://www.agemed.gob.bo/normas_consulta/NORMA-2025-01.pdf

    Accessed Date

    2026-09-16

  • Title

    Circular AGEMED N° 86/2023, numeral 4 — plazo para la emisión de Certificados de Comercialización de equipos biomédicos

    Url

    https://www.agemed.gob.bo/circulares/2023/CIRCULAR-86-2023.pdf

    Accessed Date

    2026-09-16

  • Title

    Resolución Administrativa AGEMED N° 42/2024, Directriz anexa, numerales 2 y 4.5 — alcance y plazos del procedimiento de reliance

    Url

    https://www.agemed.gob.bo/resoluciones/RA_042_2024.pdf

    Accessed Date

    2026-09-16

  • Title

    Circular MSyD/AGEMED/CR/63/2024 — disposiciones relativas a los procesos de reinscripción; identifica el Manual para Registro Sanitario de Dispositivos Médicos como aprobado por Resolución Ministerial N° 10 de 17 de enero de 2006 y su numeral 2.3.3 como requisito de reinscripción

    Url

    https://www.agemed.gob.bo/circulares/2024/CIRCULAR-63-2024.pdf

    Accessed Date

    2026-09-16

Reviewed On

2026-09-16

Process
Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps
  • Step

    1

    Title

    Pre-Submission Preparation

    Description

    Gather technical documentation, quality management system (QMS) records, and clinical data required by AGEMED. Appoint a Representante legal del fabricante extranjero, acreditado ante el Área de Vigilancia y Control de AGEMED antes de presentar la solicitud (numeral 2.3.4 del Manual).

    Duration

    1-3 months

    Icon

    📋

  • Step

    2

    Title

    Application Submission

    Description

    Submit complete registration dossier to AGEMED including device description, risk analysis, and testing reports.

    Duration

    1-2 weeks

    Icon

    📤

  • Step

    3

    Title

    Administrative Review

    Description

    AGEMED reviews application for completeness. May request additional documents or clarifications.

    Duration

    2-4 weeks

    Icon

    🔍

  • Step

    4

    Title

    Technical Evaluation

    Description

    In-depth technical assessment of device safety and performance. AGEMED may issue questions.

    Duration

    30 working days

    Icon

    ⚙️

  • Step

    5

    Title

    Registration Approval

    Description

    Upon successful review, AGEMED issues Bolivia market authorization certificate.

    Duration

    1-2 weeks

    Icon

    ✅

Government fee schedules · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Bolivia fees →
Jurisdiction Id

bolivia

Country

Bolivia

Country Code

BO

Authority

AGEMED

Low Risk Local
Min

993

Max

1489

Currency

BOB

Per Product

No

High Risk Local
Min

869

Max

1737

Currency

BOB

Per Product

No

Details
  • Id

    dispositivo-medico-importado-inscripcion

    Item

    Dispositivo médico importado — Servicio por Registro Sanitario, Inscripción

    Currency

    BOB

    Amount Local

    1489

    Amount Local Formatted

    BOB 1,489

    Frequency

    Per registration

    Notes

    Tariff item 82.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.agemed.gob.bo/archivo_agemed/nuevoarancel.pdf

    Source Title

    Resolución Ministerial N° 0265 de 25 de mayo de 2018 — arancel de servicios de la AGEMED por Registro Sanitario (dispositivos médicos, reactivos para diagnóstico, prótesis o implantes, y firmas importadoras)

    Source Effective Date

    2018-05-25

    Verified On

    2026-09-16

  • Id

    dispositivo-medico-importado-reinscripcion

    Item

    Dispositivo médico importado — Servicio por Registro Sanitario, Reinscripción

    Currency

    BOB

    Amount Local

    1117

    Amount Local Formatted

    BOB 1,117

    Frequency

    Per reinscription, every 5 years

    Notes

    Tariff item 83. Reinscription is filed within the three months before expiry of the five-year registration.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.agemed.gob.bo/archivo_agemed/nuevoarancel.pdf

    Source Title

    Resolución Ministerial N° 0265 de 25 de mayo de 2018 — arancel de servicios de la AGEMED por Registro Sanitario (dispositivos médicos, reactivos para diagnóstico, prótesis o implantes, y firmas importadoras)

    Source Effective Date

    2018-05-25

    Verified On

    2026-09-16

  • Id

    dispositivo-medico-nacional-inscripcion

    Item

    Dispositivo médico Nacional — Servicio por Registro Sanitario, Inscripción

    Currency

    BOB

    Amount Local

    993

    Amount Local Formatted

    BOB 993

    Frequency

    Per registration

    Notes

    Tariff item 84.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.agemed.gob.bo/archivo_agemed/nuevoarancel.pdf

    Source Title

    Resolución Ministerial N° 0265 de 25 de mayo de 2018 — arancel de servicios de la AGEMED por Registro Sanitario (dispositivos médicos, reactivos para diagnóstico, prótesis o implantes, y firmas importadoras)

    Source Effective Date

    2018-05-25

    Verified On

    2026-09-16

  • Id

    dispositivo-medico-nacional-reinscripcion

    Item

    Dispositivo médico Nacional — Servicio por Registro Sanitario, Reinscripción

    Currency

    BOB

    Amount Local

    745

    Amount Local Formatted

    BOB 745

    Frequency

    Per reinscription, every 5 years

    Notes

    Tariff item 85.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.agemed.gob.bo/archivo_agemed/nuevoarancel.pdf

    Source Title

    Resolución Ministerial N° 0265 de 25 de mayo de 2018 — arancel de servicios de la AGEMED por Registro Sanitario (dispositivos médicos, reactivos para diagnóstico, prótesis o implantes, y firmas importadoras)

    Source Effective Date

    2018-05-25

    Verified On

    2026-09-16

  • Id

    reactivo-diagnostico-nacional-inscripcion

    Item

    Reactivo para diagnóstico nacional — Servicio por Registro Sanitario, Inscripción

    Currency

    BOB

    Amount Local

    621

    Amount Local Formatted

    BOB 621

    Frequency

    Per registration

    Notes

    Tariff item 90. The national reagent inscription rate is the lowest of the reagent, device and implant inscription rates in section II of the table.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.agemed.gob.bo/archivo_agemed/nuevoarancel.pdf

    Source Title

    Resolución Ministerial N° 0265 de 25 de mayo de 2018 — arancel de servicios de la AGEMED por Registro Sanitario (dispositivos médicos, reactivos para diagnóstico, prótesis o implantes, y firmas importadoras)

    Source Effective Date

    2018-05-25

    Verified On

    2026-09-16

  • Id

    reactivo-diagnostico-importado-inscripcion

    Item

    Reactivo para diagnóstico importado — Servicio por Registro Sanitario, Inscripción

    Currency

    BOB

    Amount Local

    1241

    Amount Local Formatted

    BOB 1,241

    Frequency

    Per registration

    Notes

    Tariff item 92.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.agemed.gob.bo/archivo_agemed/nuevoarancel.pdf

    Source Title

    Resolución Ministerial N° 0265 de 25 de mayo de 2018 — arancel de servicios de la AGEMED por Registro Sanitario (dispositivos médicos, reactivos para diagnóstico, prótesis o implantes, y firmas importadoras)

    Source Effective Date

    2018-05-25

    Verified On

    2026-09-16

  • Id

    protesis-implante-importado-inscripcion

    Item

    Prótesis o implante importado — Servicio por Registro Sanitario, Inscripción

    Currency

    BOB

    Amount Local

    1737

    Amount Local Formatted

    BOB 1,737

    Frequency

    Per registration

    Notes

    Tariff item 96, the highest of the device, reagent and implant inscription rates in section II of the table.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.agemed.gob.bo/archivo_agemed/nuevoarancel.pdf

    Source Title

    Resolución Ministerial N° 0265 de 25 de mayo de 2018 — arancel de servicios de la AGEMED por Registro Sanitario (dispositivos médicos, reactivos para diagnóstico, prótesis o implantes, y firmas importadoras)

    Source Effective Date

    2018-05-25

    Verified On

    2026-09-16

  • Id

    protesis-implante-nacional-inscripcion

    Item

    Prótesis o implante nacional — Servicio por Registro Sanitario, Inscripción

    Currency

    BOB

    Amount Local

    869

    Amount Local Formatted

    BOB 869

    Frequency

    Per registration

    Notes

    Tariff item 98.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.agemed.gob.bo/archivo_agemed/nuevoarancel.pdf

    Source Title

    Resolución Ministerial N° 0265 de 25 de mayo de 2018 — arancel de servicios de la AGEMED por Registro Sanitario (dispositivos médicos, reactivos para diagnóstico, prótesis o implantes, y firmas importadoras)

    Source Effective Date

    2018-05-25

    Verified On

    2026-09-16

  • Id

    rectificacion-registro-sanitario

    Item

    Rectificación de Registro Sanitario, cualquiera sea el producto, nacional o importado, incluido dispositivo médico importado

    Currency

    BOB

    Amount Local

    621

    Amount Local Formatted

    BOB 621

    Frequency

    Per rectification

    Notes

    Tariff item 101, whose printed wording runs 'cualquiera sea el producto, nacional o importado, incluido dispositivo médico importado'.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.agemed.gob.bo/archivo_agemed/nuevoarancel.pdf

    Source Title

    Resolución Ministerial N° 0265 de 25 de mayo de 2018 — arancel de servicios de la AGEMED por Registro Sanitario (dispositivos médicos, reactivos para diagnóstico, prótesis o implantes, y firmas importadoras)

    Source Effective Date

    2018-05-25

    Verified On

    2026-09-16

  • Id

    segunda-evaluacion

    Item

    Segunda evaluación para Registro Sanitario, por falta de uno de los requisitos establecidos

    Currency

    BOB

    Amount Local

    621

    Amount Local Formatted

    BOB 621

    Frequency

    Per re-entry of an observed dossier

    Notes

    Tariff item 102, whose printed wording ties the second evaluation to a dossier re-entered 'por falta de uno de los requisitos establecidos según D.S. N° 25235, cualquiera sea el producto, nacional o importado'.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.agemed.gob.bo/archivo_agemed/nuevoarancel.pdf

    Source Title

    Resolución Ministerial N° 0265 de 25 de mayo de 2018 — arancel de servicios de la AGEMED por Registro Sanitario (dispositivos médicos, reactivos para diagnóstico, prótesis o implantes, y firmas importadoras)

    Source Effective Date

    2018-05-25

    Verified On

    2026-09-16

  • Id

    evaluacion-desempeno-reactivo-diagnostico

    Item

    Evaluación de desempeño para reactivo de diagnóstico cuando corresponda, sea nacional o importado

    Currency

    BOB

    Amount Local

    1241

    Amount Local Formatted

    BOB 1,241

    Frequency

    Per performance evaluation

    Notes

    Tariff item 107, under the control-of-quality and performance-evaluation section of the table.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.agemed.gob.bo/archivo_agemed/nuevoarancel.pdf

    Source Title

    Resolución Ministerial N° 0265 de 25 de mayo de 2018 — arancel de servicios de la AGEMED por Registro Sanitario (dispositivos médicos, reactivos para diagnóstico, prótesis o implantes, y firmas importadoras)

    Source Effective Date

    2018-05-25

    Verified On

    2026-09-16

  • Id

    importadora-dispositivos-apertura

    Item

    Firmas Importadoras de Dispositivos Médicos — Evaluación e Inspección por apertura

    Currency

    BOB

    Amount Local

    4964

    Amount Local Formatted

    BOB 4,964

    Frequency

    Per establishment opening

    Notes

    Tariff item 34. Charged to the importing firm, not per product; AGEMED's Form 096 requirements sheet states the same amount for the same item.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.agemed.gob.bo/archivo_agemed/nuevoarancel.pdf

    Source Title

    Resolución Ministerial N° 0265 de 25 de mayo de 2018 — arancel de servicios de la AGEMED por Registro Sanitario (dispositivos médicos, reactivos para diagnóstico, prótesis o implantes, y firmas importadoras)

    Source Effective Date

    2018-05-25

    Verified On

    2026-09-16

  • Id

    importadora-dispositivos-inspeccion-anual

    Item

    Firmas Importadoras de Dispositivos Médicos — Inspección anual

    Currency

    BOB

    Amount Local

    1241

    Amount Local Formatted

    BOB 1,241

    Frequency

    Annual

    Notes

    Tariff item 35; the GMP or GAP audit of the same firms is item 37 at BOB 1,862.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.agemed.gob.bo/archivo_agemed/nuevoarancel.pdf

    Source Title

    Resolución Ministerial N° 0265 de 25 de mayo de 2018 — arancel de servicios de la AGEMED por Registro Sanitario (dispositivos médicos, reactivos para diagnóstico, prótesis o implantes, y firmas importadoras)

    Source Effective Date

    2018-05-25

    Verified On

    2026-09-16

Notes
  • Every published amount is an exact boliviano figure in the tariff table; no formula or base unit is involved, so no amount here is derived.
  • Registration tariffs are charged per product registration, not per family and not per model.
  • Pricing is by product category and by national or imported origin: a national prosthesis or implant (item 98, BOB 869) costs less than an imported non-implant device (item 82, BOB 1,489), which is why the low-risk and high-risk bands overlap.
  • The schedule is the annex to Resolución Ministerial N° 0265 of 25 May 2018: the scanned first page carries 'RESOLUCIÓN MINISTERIAL N° 0265' with a '25 MAY' date stamp, its Article Segundo derogates Resolución Ministerial N° 0493 of 2 August 2004, and the document's own scan metadata records 30 May 2018. AGEMED's Circular N° 86/2023 numeral 3 independently cites the current schedule as Resolución Ministerial N° 0265 de 25 de mayo de 2018 and its item N° 138 as the Certificación de Comercialización — the same item and wording this table carries — so the effective date published here is the resolution's own date.
  • Device-specific reinscription and modification charges sit in the same table: item 83 BOB 1,117 and item 85 BOB 745 for reinscription of imported and national devices.
  • The AGEMED tariff does not differentiate by device risk class: it prices by product category (dispositivo médico, reactivo para diagnóstico, prótesis o implante) and by national or imported origin. The low-risk band published here is therefore the general device inscription range (item 84 BOB 993 national to item 82 BOB 1,489 imported) and the high-risk band is the prosthesis or implant inscription range (item 98 BOB 869 national to item 96 BOB 1,737 imported), which is why the two bands overlap.
Last Updated

2026-09-16

Verification Status

official-verified

Official Sources
  • Title

    Resolución Ministerial N° 0265 de 25 de mayo de 2018 — arancel de servicios de la AGEMED por Registro Sanitario (dispositivos médicos, reactivos para diagnóstico, prótesis o implantes, y firmas importadoras)

    Url

    https://www.agemed.gob.bo/archivo_agemed/nuevoarancel.pdf

    Effective Date

    2018-05-25

    Accessed Date

    2026-09-16

Reviewed On

2026-09-16

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Bolivia certifications →
Slug

bolivia

Market

Bolivia

Confidence

low

Schemes
  • Id

    agemed-device-dossier-quality-and-clinical-evidence

    Name

    AGEMED device registration dossier — quality-system certificate and technical documentation

    Category

    Medical Electrical Safety

    Status

    Included In Medical Registration

    Object

    Finished Device

    Note

    There is no separate Bolivian electrical-safety or EMC certificate for a medical device: the evidence is filed inside the Registro Sanitario dossier. Numeral 2.3.1 of the Manual para Registro Sanitario de Dispositivos Médicos requires the original or a health-authority-legalised copy of the quality-system certification in use — Good Manufacturing Practices or its equivalent, and the certificate must not be older than two years — while reserving AGEMED's power to require in-situ verification of the plant or reports from the origin authority at any time. Numeral 2.4 requires the technical information set, and numeral 2.4.8 requires clinical studies for a new product of moderate-high or high risk. The dossier is filed on Formulario 027.

    Source Urls
    • https://www.agemed.gob.bo/reg-far/doc_reg_far/T-N-35-RM-00113-BGM.pdf
    Source Binding

    candidate

  • Id

    agemed-imported-device-free-sale-certificate

    Name

    AGEMED imported-device dossier — consularised certificate of free sale from the origin authority

    Category

    Import Conformity

    Status

    Included In Medical Registration

    Object

    Imported Medical Device

    Note

    Under numeral 2.3.2 of the Manual para Registro Sanitario de Dispositivos Médicos an imported device must be accompanied by a certificate issued by the competent national health authority of the country of origin stating that the product is duly authorised there, legalised by a Bolivian consulate; where the country of origin has no Bolivian consular representation, the document must instead be certified by Bolivia's Ministry of Foreign Affairs together with the original. This is a mandatory element of the local dossier and does not shorten or replace the local evaluation: Article 11 of Decreto Supremo N° 25235 separately requires a prior Registro Sanitario for manufacture, import, distribution or marketing.

    Source Urls
    • https://www.agemed.gob.bo/reg-far/doc_reg_far/T-N-35-RM-00113-BGM.pdf
    Source Binding

    candidate

  • Id

    att-homologation-radio-and-ict-equipment

    Name

    ATT homologation — telecommunications and ICT equipment using the radioelectric spectrum

    Category

    Radio Spectrum

    Status

    Mandatory If Feature

    Object

    Telecom And Ict Equipment Using Radio Spectrum

    Note

    Numeral 9 of Article 14 of Ley N° 164 makes it an ATT attribution to homologate telecommunications and ICT equipment throughout the country, and Article 14 of Decreto Supremo N° 1391 defines homologación as the ATT's verification of equipment or terminal compatibility with a telecommunications network and of appropriate use of the radioelectric spectrum. Resolución Administrativa Regulatoria ATT-DJ-RAR-TL LP 539/2024 of 6 November 2024 approved the current Instructivo para el Registro y Homologación de Equipos de Telecomunicaciones y TIC: Article 10 has the ATT publish the categories and subcategories of equipment subject to homologation, and Article 14 requires a certificate of conformity from an international body recognised by the ATT plus the laboratory test reports. The applicant must first hold a Certificado de Registro as a provider or commercialiser. A medical device with a radio transmitter therefore needs an ATT homologation in addition to its AGEMED registration.

    Source Urls
    • https://www.att.gob.bo/sites/default/files/archivos_portada/2024-12/ATT-DJ-RAR-TL%20LP%20539_2024.PDF
    • https://www.att.gob.bo/resolucion-administrativa-regulatoria-att-dj-rar-tl-lp-5392024
    Source Binding

    reviewed

  • Id

    att-homologation-terminal-network-equipment

    Name

    ATT homologation — terminal equipment connected to public telecommunications networks

    Category

    Telecom Network Attachment

    Status

    Mandatory If Feature

    Object

    Terminal Equipment Connected To Public Networks

    Note

    The same ATT homologation regime covers terminal equipment by reference to its connection to the public network: Article 14 of Decreto Supremo N° 1391 states that homologación verifies the compatibility of operation of equipment or terminals with a telecommunications network, and Article 15.I allows the ATT to require a prototype of each equipment type for laboratory testing. The Instructivo approved by Resolución Administrativa Regulatoria ATT-DJ-RAR-TL LP 539/2024 defines 'terminal de telecomunicaciones' and 'equipo de telecomunicaciones' and requires the certificate of conformity and test reports of Article 14. Article 12 of the same instructivo makes it unlawful to advertise equipment as homologated without the certificate.

    Source Urls
    • https://www.att.gob.bo/sites/default/files/archivos_portada/2024-12/ATT-DJ-RAR-TL%20LP%20539_2024.PDF
    • https://www.att.gob.bo/resolucion-administrativa-regulatoria-att-dj-rar-tl-lp-5392024
    Source Binding

    reviewed

  • Id

    ibmetro-legal-metrology-verification

    Name

    IBMETRO legal metrology — periodic verification of weighing instruments used in health establishments

    Category

    Legal Metrology

    Status

    Mandatory If Feature

    Object

    Regulated Measuring Instrument

    Note

    IBMETRO's Dirección de Metrología Legal verifies the measuring instruments, equipment and products whose use can affect commercial transactions, health, the economy, security or the environment, under Decreto Ley N° 15380 (Ley Nacional de Metrología). Its published verification pages name weighing instruments (balanzas and básculas) used in commercial transactions, custody transfer and health as subject to periodic verification, and list hospitals and diagnostic centres among the rubros in which those instruments must be verified; the same directorate verifies net content, service stations and volumetric meters. Clinical and laboratory weighing equipment used in a health establishment therefore carries a periodic IBMETRO verification separate from the AGEMED registration.

    Source Urls
    • https://ibmetro.gob.bo/balanzas
    • https://ibmetro.gob.bo/verificacion
    Source Binding

    reviewed

Official Sources
  • Authority

    AGEMED

    Topic

    Manual para Registro Sanitario de Dispositivos Médicos (Resolución Ministerial N° 10 de 17 de enero de 2006) — requirements, procedure, classification and clocks

    Url

    https://www.agemed.gob.bo/reg-far/doc_reg_far/T-N-35-RM-00113-BGM.pdf

  • Authority

    ATT

    Topic

    Resolución Administrativa Regulatoria ATT-DJ-RAR-TL LP 539/2024 — Instructivo para el Registro y Homologación de Equipos de Telecomunicaciones y TIC

    Url

    https://www.att.gob.bo/sites/default/files/archivos_portada/2024-12/ATT-DJ-RAR-TL%20LP%20539_2024.PDF

  • Authority

    ATT

    Topic

    homologation resolution record and homologation register

    Url

    https://www.att.gob.bo/resolucion-administrativa-regulatoria-att-dj-rar-tl-lp-5392024

  • Authority

    IBMETRO

    Topic

    periodic verification of weighing instruments in commercial, transport, mining, hydrocarbons, health and import rubros (Decreto Ley N° 15380)

    Url

    https://ibmetro.gob.bo/balanzas

  • Authority

    IBMETRO

    Topic

    Dirección de Metrología Legal — verification services and scope

    Url

    https://ibmetro.gob.bo/verificacion

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