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Bolivia medical device registration timeline

Source-linked clocks

Agencia Estatal de Medicamentos y Tecnologías en Salud (AGEMED) review clocks and end-to-end planning ranges, using the 4-class (I, IIa, IIb, III) — GHTF classification rules in numeral 1.7.2 of the Manual para Registro Sanitario de Dispositivos Médicos classification system.

5 pathways5 of 5 clocks verifiedvalidity 5 years for a device, reagent, prosthesis or implant Registro Sanitario (numeral 3.1.5 del Manual), renewable by reinscripciónMDSAP not acceptedreviewed 2026-09-16agemed.gob.bo
Class / pathwayReview clockPlanning totalWith prior approvalProvenance
Clases I, IIa, IIb y III — inscripción del Registro Sanitario(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)
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.
30 working days4-9 months—Verified
Equipos biomédicos — Certificado de Comercialización(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))
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.
5 working days1-2 months—Verified
Inscripción por reliance — decisión regulatoria de una autoridad de referencia(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)
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.
2 months3-6 months—Verified
Renovación o rectificación por reliance(Renewal or rectification processed under the reliance directive annexed to Resolución Administrativa AGEMED N° 42/2024)
Numeral 4.5 fixes 1 month for renewal or rectification under the reliance route, half the inscription period.
1 month1-3 months—Verified
Reinscripción del Registro Sanitario a los cinco años(Reinscription following the same procedure as inscription except for the requirements expressly indicated, filed within the three months before expiry)
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.
30 working days2-6 months—Verified
Review clocks exclude applicant hold time · planning totals are estimates

Planning steps and estimates; these are not regulator deadlines.

Bolivia Medical Device Registration Process

Step-by-step AGEMED registration process. Total estimated timeline: 4-9 months.

Step 1: Pre-Submission Preparation

1-3 months

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).

Step 2: Application Submission

1-2 weeks

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

Step 3: Administrative Review

2-4 weeks

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

Step 4: Technical Evaluation

30 working days

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

Step 5: Registration Approval

1-2 weeks

Upon successful review, AGEMED issues Bolivia market authorization certificate.

Summary: The Bolivia medical device registration process through Agencia Estatal de Medicamentos y Tecnologías en Salud (AGEMED) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.
Expedited pathways
Reliance sobre decisiones regulatorias de otros paísesShorter documentary analysis, with no published period for the ordinary route to compare against

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.

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 approval recognition
FDA 510(k)/PMANo 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.
EU CE markingNo 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.
PAHO/WHO reference authority or WHO-listed authority registrationAdmissible 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).
Primary regulator sources
agemed.gob.bo · 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 agemed.gob.bo · 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 agemed.gob.bo · Circular AGEMED N° 86/2023, numeral 4 — plazo para la emisión de Certificados de Comercialización de equipos biomédicos agemed.gob.bo · Resolución Administrativa AGEMED N° 42/2024, Directriz anexa, numerales 2 y 4.5 — alcance y plazos del procedimiento de reliance agemed.gob.bo · 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

Reviewed 2026-09-16. End-to-end totals remain planning estimates.

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Source-linked review clocks verified against AGEMED publications · full review 2026-09-16 · row IDs are stable — cite as registration-timeline:bolivia:registro-sanitario-inscription