AGEMED · Americas

Bolivia medical device regulatory resources

Every Bolivia dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

5 free resources24/25 topics with records11 regulations trackedSep 2026 fees reviewed

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Government registration fees

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Registration timeline

Compare official and realistic approval times by device class and pathway.

Browse Bolivia's official medical-device instruments — AGEMED's sanitary-registration manuals for devices and IVDs, the implementing and founding decrees, and its administrative resolutions and requirements lists — with citeable Spanish passages.

Structured regulatory requirements

Explore all 45 source-linked facts →

24 of 25 research dimensions currently covered · 22 official sources · latest verification 2026-09-16

Market entry

D01

Authority & regime

Verified

AGEMED's statutory functions cover evaluation, authorisation and post-market control of health technologies: statement: AGEMED's statutory functions include issuing prior import authorisations and company opening authorisations, issuing technical procedures, evaluating, authorising, regulating, co…
AGEMED is the national regulatory authority, a decentralised public body of the Ministry of Health: 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 contro…

2 source-linked facts

Checked 2026-09-16

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D02

Legal basis & guidance

Verified

The Manual for Sanitary Registration of Medical Devices was approved by Resolución Ministerial N° 0010 of 17 January 2006: statement: The Manual para Registro Sanitario de Dispositivos Médicos is the technical instrument that sets the requirements and procedure for device registration, and AGEMED's circulars id…
Ley del Medicamento 1737 brings medical devices and diagnostic reagents within the registration regime: statement: For regulatory purposes, 'medicamentos reconocidos por Ley' under Article 4(g) of Ley N° 1737 of 17 December 1996 explicitly include 'dispositivos médicos, substancias para diagn…

2 source-linked facts

Checked 2026-09-16

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D03

Device definition & scope

Verified

Bolivian medical-device definition, including IVD examination of body-derived samples: 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, materi…
Existing insumo, miscellaneous and dental registrations are absorbed into the medical-device category: statement: For harmonisation purposes and under the manual, all companies registered in the categories of insumos, miscellaneous products and dental products, and all sanitary registrations…

2 source-linked facts

Checked 2026-09-16

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D04

Classification rules

Verified

Clases I, IIa, IIb y III — reglas de clasificación GHTF del Manual para Registro Sanitario de Dispositivos Médicos: Clase I — riesgo bajo, controles generales, Clase IIa — riesgo moderado, controles especiales de fabricación, Clase IIb — riesgo alto, controles especiales de diseño, Clase III — riesgo más alto

1 maintained scheme · 1 related fact

Checked 2026-09-16

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D05

Registration pathways

Verified

Biomedical equipment may be placed through a Certificado de Comercialización instead of a full Registro Sanitario: statement: For medical devices considered biomedical equipment, AGEMED issues 'Certificados de Comercialización' that recognise a declaration made by the manufacturer or the Bolivian repres…
A listed set of low-risk articles is exempt from Registro Sanitario: statement: AGEMED maintains a list of medical devices that are not subject to Registro Sanitario (annex to Circular MS/AGEMED/CR/43/2018, 133 items with codes, e.g. ampoule openers, bath pi…

4 source-linked facts

Checked 2026-09-16

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D06

Reliance & recognition

Verified

Certificate of free sale from the country of origin is mandatory dossier evidence for imported devices: statement: For imported medical devices the applicant must file a certificate of the medical device issued by the competent national health authority of the country of origin, stating that…
Use of another country's regulatory decision under the AGEMED reliance directive (RA 42/2024): 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 (Confia…

2 source-linked facts

Checked 2026-09-16

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D07

Economic-operator roles

Verified

Every commercial package must identify the company that markets the device in Bolivia: statement: Under Article 149 of DS 25235, every commercial package of a product, imported or national, must carry a sticker, seal, label or imprint identifying the company that markets the…
The Registro Sanitario belongs to the manufacturer or licensor, not to the company that filed it: statement: The Registro Sanitario certificate does not necessarily belong to the company that carried out the registration procedure; it belongs to whoever holds the licence or is the manuf…

3 source-linked facts

Checked 2026-09-16

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D08

Establishment, import & distribution

Verified

The manufacturer's legal representation must be filed with AGEMED's vigilance and control area before the dossier: statement: Legal representation of the manufacturer is not a document included in each registration dossier: it must have been filed beforehand with the Área de Vigilancia y Control as a pr…

1 source-linked fact

Checked 2026-09-16

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D09

Dossier requirements

Verified

Legal and administrative dossier package: statement: The legal administrative part of the device dossier comprises a photocopy of the ministerial or secretarial resolution authorising the company to operate, a photocopy of the curr…
Quality-system certificate (GMP or equivalent) with a two-year age limit: statement: The applicant must file the original or a copy legalised by a health authority — not necessarily consularised — of the quality system certification in use, being Good Manufacturi…

3 source-linked facts

Checked 2026-09-16

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D10

Official forms & portals

Verified

Form 027 is the official device registration application form: statement: Form 027, 'Solicitud para Registro de Dispositivo Médico Equipo', is the official AGEMED application form for device and equipment registration. It records the type of procedure…

1 source-linked fact

Checked 2026-09-16

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Submission & evidence

D11

Label, IFU & language

Verified

IFU and operation, maintenance and installation manuals must be in Spanish: statement: Where the device or biomedical equipment carries operation, maintenance or installation manuals, they must contain sufficient information to ensure proper execution of the proced…
Labels in several languages are accepted provided one of them is Spanish: statement: Labels and package markings with wording in several languages are accepted provided one of them is Spanish. The minimum content is the product name, lot or serial number, expiry…

2 source-linked facts

Checked 2026-09-16

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D12

QMS, audit & inspection

Verified

AGEMED may verify the manufacturing plant in situ or request information from the origin regulator: statement: Independently of the quality system certificate filed, the competent directorate may at any time require in situ verification of the plant or request information or reports from…

1 source-linked fact

Checked 2026-09-16

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D13

Standards, testing & ancillary approvals

Unresolved

AGEMED device registration dossier — quality-system certificate and technical documentation: Electrical safety
AGEMED imported-device dossier — consularised certificate of free sale from the origin authority: Import CoC / PVoC
ATT homologation — telecommunications and ICT equipment using the radioelectric spectrum: Wireless / radio

5 maintained overlays

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D14

Fees

Verified

Dispositivo médico importado — Servicio por Registro Sanitario, Inscripción: BOB 1,489
Dispositivo médico importado — Servicio por Registro Sanitario, Reinscripción: BOB 1,117

13 maintained fee lines · 2 related facts

Checked 2026-09-16

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D15

Review clocks

Verified

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: 30 working days
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): 5 working days
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: 2 months

5 maintained pathways · 1 related fact

Checked 2026-09-16

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D16

Approval validity & renewal

Verified

Reinscription must be filed in the three months before expiry, with a 30-day tolerance after expiry: statement: Reinscription follows the same procedure as inscription except for the requirements expressly indicated, and should be filed within the three months before expiry of the Registro…
The registration remains valid while a reinscription is in process: statement: During the reinscription process the Registro Sanitario continues to be valid for manufacture, import, distribution, marketing and acquisition until the updated Registro Sanitari…

3 source-linked facts

Checked 2026-09-16

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Lifecycle & post-market

D17

Change control

Verified

Adding items to an existing registration is a rectification, limited to the same risk class and group: statement: The inclusion of further items that correspond to a registration already granted is treated as a rectification, with the whole corresponding documentation to be submitted, and is…
Non-substantial changes are handled as rectifications that preserve the original registration number: statement: Rectification, which preserves the number, code and validity originally granted, is available for modifications that do not imply a substantial change — for example variation in…

2 source-linked facts

Checked 2026-09-16

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D18

UDI, listing & traceability

Verified

Traceability is by lot coding and, for biomedical equipment, by serial number and installation site: statement: Bolivia operates no UDI system; traceability is built from the lot or serial number on the label, the lot coding of the finished product which must be described with its interpre…

1 source-linked fact

Checked 2026-09-16

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D19

Clinical investigation & performance

Verified

Clinical studies are required for new moderate-high and high-risk devices: statement: For products classified as moderate high risk and high risk, particularly for new products, clinical studies on use must be presented to demonstrate the safety and efficacy of th…

1 source-linked fact

Checked 2026-09-16

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D20

Special access & derogation

Verified

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

1 source-linked fact

Checked 2026-09-16

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D21

Manufacturer PMS

Verified

Reference-price and monthly stock reporting for medicines, vaccines, medical devices, diagnostic reagents and medical equipment: statement: AGEMED established a technical administrative reporting regime whose chapeau expressly covers 'medicamentos, vacunas, dispositivos médicos, reactivos de diagnóstico y equipos méd…
Start-of-commercialisation notification and the other mandatory ongoing notifications for a registered device: statement: The registration holder must notify AGEMED's Dirección de Medicamentos y Tecnología en Salud of the start of commercialisation of each registered device before commercialisation…

2 source-linked facts

Checked 2026-09-16

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D22

Vigilance & incident reporting

Verified

AGEMED may cancel a device registration during its validity on three grounds: statement: AGEMED may cancel the Registro Sanitario of a medical device during its term at the request of the interested party after evaluation, where substantial changes are found in the a…
Withdrawal after cancellation is executed within 72 hours, three months or nine months according to health severity: statement: When a Registro Sanitario is cancelled, the withdrawal of the product from the market is set according to the severity in health terms, under the responsibility of the company, w…

2 source-linked facts

Checked 2026-09-16

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D23

Recall, FSCA & market surveillance

Verified

Batch-withdrawal classification (Clase I/II/III) and the deadlines for executing a withdrawal of one or more batches: statement: A batch withdrawn from the market under Bolivia's National System for the Vigilance and Control of Medicines is classified by the seriousness of the defect, and the classificatio…
Who must execute a batch withdrawal, the written-procedure duty, and the contents of the withdrawal report to the authority: statement: The withdrawal of a batch from the Bolivian market is the voluntary, or authority ordered, procedure by which a manufacturing batch is taken off the market; it must be executed b…

2 source-linked facts

Checked 2026-09-16

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D24

Advertising, claims & promotion

Verified

Advertising, promotion and propaganda directed at the general population requires prior authorisation: statement: Under Ley del Medicamento N° 1737 art. 59(f), advertising, promotion and propaganda of medicines directed at the general population without the prior authorisation of the Ministr…
Substantive rules on promotion and advertising of medicines, and their binding force: statement: Bolivia's substantive rules on the promotion and advertising of medicinal products are the Normas Éticas para la Promoción de Medicamentos, approved on 1 March 1994 and published…

2 source-linked facts

Checked 2026-09-16

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D25

Submission communications & appeal

Verified

A rejected applicant may file a recurso de reconsideración within 15 working days: 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 foll…
Observed dossiers have 60 calendar days to remedy; rejected dossiers may re-enter within 60 calendar days on payment: statement: Where a device dossier is observed for a remediable technical point, the interested party is given a note detailing the observations, which must be remedied within 60 calendar da…

2 source-linked facts

Checked 2026-09-16

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Government fees

Full fee schedule (13 lines) →

AGEMED registration fees in BOB · reviewed 2026-09-16

Fee line	Amount	Provenance
Dispositivo médico importado — Servicio por Registro Sanitario, Inscripción	BOB 1,489	Verified
Dispositivo médico importado — Servicio por Registro Sanitario, Reinscripción	BOB 1,117	Verified
Dispositivo médico Nacional — Servicio por Registro Sanitario, Inscripción	BOB 993	Verified
Dispositivo médico Nacional — Servicio por Registro Sanitario, Reinscripción	BOB 745	Verified

9 more fee lines on the full schedule · 13 of 13 rows source-verified

Registration timeline

Full registration timeline →

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

Class / pathway	Review clock	Planning total	Provenance
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)	30 working days	4-9 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))	5 working days	1-2 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)	2 months	3-6 months	Verified
Renovación o rectificación por reliance(Renewal or rectification processed under the reliance directive annexed to Resolución Administrativa AGEMED N° 42/2024)	1 month	1-3 months	Verified