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AGEMED · structured requirements

🇧🇴 Bolivia medical device regulatory data

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

45 facts24 dimensions19 official sourceslatest verification 2026-09-16

Advertising, claims & promotion

Which claims, audiences, channels, approvals, and restrictions apply?

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Advertising, promotion and propaganda directed at the general population requires prior authorisation

advertising.mass-media-advertising-requires-prior-ministry-authorisation
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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 Ministry of Human Development acting through the National Health Secretariat is a punishable infringement. The requirement is therefore a prior-authorisation requirement, enforced through the infringement list rather than through a stand-alone licensing article, and it sits alongside art. 50's delegation of the publication, promotion, propaganda and advertising of medicines to the Ministry on the basis of the Normas Éticas. The function is now exercised by AGEMED: art. 7(c) of DS 2905, recited in the VISTOS of RA 20/2023, gives AGEMED the function of evaluating, authorising, regulating, policing and inspecting, among other things, the 'promoción, publicidad ... de medicamentos y tecnologías en salud'.

Article

Artículo 59(f)

Conditions
  • DEVICE SCOPE: art. 59(f) is drafted 'de medicamentos'. Devices fall inside the statute by Ley 1737 art. 2 and art. 4(g), which place 'dispositivos médicos' within the law's ambit and among the 'Medicamentos especiales' respectively; no device-specific prior-authorisation article for advertising was found.
  • Art. 59 opens with 'Se considerará como infracción punible a la transgresión de los artículos señalados en esta Ley y su reglamento, principalmente a:', so the list states punishable conduct rather than prohibiting it in its own right; it is nevertheless the provision that establishes that the authorisation must pre-exist the advertising.
  • Art. 50 defines publication, promotion, propaganda and advertising for the purposes of the law as 'la presentación y divulgación de datos y/o información por cualquier medio, tendente a promover la venta, transferencia, y/o uso de medicamentos'.
  • The Normas Éticas para la Promoción de Medicamentos (T-N-6) are the substantive instrument referred to by art. 50 and by DS 25235 art. 96; see advertising.promotion-and-advertising-governed-by-medicines-ethics-norms.
  • The 'Ministerio de Desarrollo Humano / Secretaría Nacional de Salud' named in art. 59(f) is the predecessor of today's Ministerio de Salud y Deportes and of AGEMED, as recited in RA 20/2023's VISTOS.

Effective from 1996-12-17

Resolución Administrativa N° 20 de 18 de octubre de 2023 — régimen técnico-administrativo de reporte de precios referenciales y existencias para medicamentos, vacunas, dispositivos médicos, reactivos de diagnóstico y equipos médicos

Source language: Spanish. RA 20/2023 is named as a supporting source because its VISTOS recite art. 7(c) of DS 2905 and so establish, from an instrument read in full for this round, which body now holds the promotion and advertising function; the substantive rule itself is proved by Ley 1737.

Substantive rules on promotion and advertising of medicines, and their binding force

advertising.promotion-and-advertising-governed-by-medicines-ethics-norms
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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 by AGEMED as technical norm T-N-6. Numeral 4 states that the norms constitute legal obligations ('Las normas constituyen obligaciones legales'), with self-regulation permitted only as a complement. Numeral 3 makes them applicable to medicines sold with and without prescription, to traditional medicines where relevant, and to 'cualquier otro producto anunciado como medicina', and directs them at government, the pharmaceutical industry, the advertising industry, health personnel, universities, professional bodies, patient and consumer groups and the media. Numeral 5 defines promotion as all informative and persuasive activities deployed by manufacturers and distributors to induce the prescribing, supply, acquisition or use of medicines. Numeral 6 requires active promotion within the country to be limited to legally obtainable medicines, to conform to national policy and regulations, and to be truthful, exact, accurate, informative, balanced, up to date, capable of substantiation and in good taste; it prohibits disparaging the Ministry of Health's health and medicines programmes through promotional activities or materials, declarations liable to misinterpretation or incapable of substantiation, and omissions that could induce a medically unjustified use or undue risks; it forbids the words 'inocuo', 'seguridad', 'carece de efectos secundarios', 'mejor' and 'más potente'; and it requires product comparisons to be factual, impartial and verifiable. The norms have statutory force because Ley 1737 art. 50 (Chapter XVI, Publicaciones, Promoción y Publicidad sobre Medicamentos) directs the Ministry to regulate publication, promotion, propaganda and advertising of medicines 'en base a las normas éticas para la promoción de medicamentos', and DS 25235 art. 96 provides that publication, promotion and advertising of medicines 'se regirá por las Normas Éticas para la Promoción de Medicamentos'.

Article

Numerales 3-6

Conditions
  • DEVICE SCOPE: the Normas Éticas are drafted for medicines, and the words 'dispositivo' or 'dispositivo médico' do not appear in them. Medical devices fall inside the medicines regime by two express provisions: Ley 1737 art. 2, which makes the statute regulate inter alia 'medicamentos especiales, como biológicos, vacunas, hemoderivados, alimentos de uso médico, cosméticos, productos odontológicos, dispositivos médicos, productos homeopáticos, y productos medicinales naturales y tradicionales'; and Ley 1737 art. 4(g), which lists 'dispositivos médicos, substancias para diagnóstico y reactivos para laboratorio clínico' among the 'Medicamentos especiales'. The device registration manual T-N-35 confirms this in practice: its applicable-norms table lists 'Normas Éticas para la Promoción de Medicamentos — 0136 — 01-03-94' as norm 6 of the norms governing device registration. No device-specific advertising instrument was found.
  • Numeral 6's restriction on public-directed advertising is reinforced by the infringement in Ley 1737 art. 59(f) (see advertising.mass-media-advertising-requires-prior-ministry-authorisation). The instrument's own introduction records the policy of 'suprimiendo toda publicidad directa al público en general' and describes the document as Bolivia's national adaptation of the WHO 'Criterios Éticos para la Promoción de Medicamentos'.
  • The instrument carries no visible approval clause of its own. Its approval number is given inconsistently in the Bolivian record: DS 25235 art. 96 cites 'R.S. No. 0139/94 del 1 de marzo de 1994', while AGEMED's own applicable-norms table in T-N-35 cites 'R.M. 0136, 01-03-94'. Both give the same date; the discrepancy is recorded rather than resolved.
  • The document has no publication or entry-into-force clause; effectiveFrom above is the common approval date recorded in both citations.
  • AGEMED's own index of national norms contains no separate publicity or promotion norm for medicines or devices, so this instrument plus Ley 1737 Chapter XVI and DS 25235 art. 96 are the whole of the framework.

Effective from 1994-03-01

Ley del Medicamento N° 1737 de 17 de diciembre de 1996Decreto Supremo N° 25235 de 30 de noviembre de 1998 — Reglamento a la Ley del Medicamento N° 1737Manual para Registro Sanitario de Dispositivos Médicos (AGEMED technical norm T-N-35, file RM-00113-BGM)

Source language: Spanish. Read in full as text (21,614 bytes of extracted text); the excerpt is the contiguous verbatim of numerals 3-6 with omissions marked. The three supporting sources are declared in this file: Ley 1737 art. 50 and DS 25235 art. 96 give the norms their binding force, and T-N-35 shows they are cited as applicable norms in the device registration manual.

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

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Reinscription must be filed in the three months before expiry, with a 30-day tolerance after expiry

renewal.reinscription-window-and-late-tolerance
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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 Sanitario. A request presented before the five years are completed, and as a tolerance up to a limit of 30 working days after the expiry of the Registro Sanitario, may be treated as a reinscription, the registration remaining valid for manufacture, import, distribution and marketing. Reinscription requests presented up to 30 calendar days after expiry must pay the fee corresponding to an inscription.

Article

Numeral 2.3.3(a) and numeral 3.1.7

Conditions
  • The manual states the tolerance twice with different units: numeral 3.1.7 says 'hasta 30 días calendario después de la caducidad' for the payment consequence, while numeral 2.3.3(a) and AGEMED's Circular 63/2024 say 'hasta un límite de 30 días hábiles posteriores a la vigencia'. Treat the 30-working-day tolerance in numeral 2.3.3(a) as the operative eligibility rule, as AGEMED restated it in CIRC 63/2024.
  • Reinscription is not a shortened review: the same dossier requirements apply.

Source language: Spanish. English translation: 'a) Any request presented before the five years are completed and, as a tolerance, up to a limit of 30 working days after the expiry of the Sanitary Registration, may be considered as a reinscription procedure, the Sanitary Registration remaining valid for manufacture, import, distribution and marketing.'

The registration remains valid while a reinscription is in process

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During the reinscription process the Registro Sanitario continues to be valid for manufacture, import, distribution, marketing and acquisition until the updated Registro Sanitario is issued, provided the application was filed within the window set by numeral 2.3.3(a) of the device manual.

Article

Closing paragraph

Conditions
  • Applies to device and medicine reinscriptions alike, as the circular addresses both.
  • Depends on the application having been filed within the 5-year term or within the 30-working-day tolerance.

Effective from 2024-12-04

Source language: Spanish (scanned circular, read via OCR). English translation: 'Consequently, during the reinscription process the Sanitary Registration shall continue to be valid for manufacture, import, distribution, marketing and acquisition until the updated Sanitary Registration is issued.'

Device registration is issued for five years

validity.registro-sanitario-five-years
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Within 30 working days from entry of the dossier to the Directorate of Medicines and Health Technology, the original Registro Sanitario certificate is delivered with a validity of 5 years, together with two legalised copies at no cost, which the regent, technical responsible or accredited representative must sign.

Article

Numeral 3.1.5

Conditions
  • The five-year term starts from issuance.
  • The 30-working-day period is stated in the same numeral and is the delivery deadline rather than a substantive review clock.

Source language: Spanish. English translation: '3.1.5 Delivery of the Sanitary Registration Certificate: Within a period of 30 working days from the date of entry to the Directorate of Medicines and Health Technology, the original Sanitary Registration Certificate shall be delivered with a validity of 5 years and the right to two legalised copies thereof at no cost, the regent or technical responsible or accredited representative being required to sign the copies of the certificate received.'

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
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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
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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.'

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

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Adding items to an existing registration is a rectification, limited to the same risk class and group

change.ampliations-limited-to-same-class-and-group
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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 allowed only where the items share the same risk classification and group.

Article

Numeral 5.10.2

Conditions
  • Because devices are registered by group, an added item outside the group requires a separate registration.

Source language: Spanish. English translation: '5.10.2 Ampliations: The inclusion of other items corresponding to a sanitary registration already granted shall be considered rectifications, and all the documentation shall be submitted as applicable. This shall proceed only where the items have the same risk classification and group.'

Non-substantial changes are handled as rectifications that preserve the original registration number

change.rectification-scope-and-requirements
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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 secondary components, packaging, labelling, design, power source, manufacturing processes, shelf life, or change of corporate name of the manufacturer or the holder. The requirements are a letter of request stating the type of rectification, a new Form 027 containing the rectification and the date of the last rectification, the original registration certificate, the technical documentation supporting the change, and proof of payment of the corresponding fee.

Article

Numeral 2.10 and numeral 5.10

Conditions
  • A registrado certificate is reissued as a 'Registro Sanitario Rectificado' respecting the code, number and validity originally granted.
  • Changes not covered by a rectification, including substantial changes in the approved parts and components, are grounds for cancellation of the registration (numeral 5.11(b)).

Source language: Spanish. English translation: '2.10 Requirements for rectifications of the Sanitary Registration of a Medical Device: For cases of rectification of the Sanitary Registration of a Medical Device, the following are requirements to be submitted in order to carry out the corresponding technical evaluation: a) Letter of request for rectification indicating the type of rectification required; b) New DINAMED Form 027 duly completed, which shall contemplate the rectification required as well as the date of the last rectification; c) Original Sanitary Registration Certificate; d) Technical documentation supporting the rectification...; e) Copy of the payment order for the corresponding service.'

Classification rules

What local class follows from which rules and decisive product facts?

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Four risk classes (I, IIa, IIb, III) applying the GHTF classification rules

classification.four-risk-classes-with-ghtf-rules
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Statement

Bolivia classifies medical devices into four classes: Class I (low risk, general controls), Class IIa (moderate risk, special manufacturing controls), Class IIb (high risk, special design and manufacturing controls) and Class III (very high risk, special controls, intended to protect or sustain life or of substantial importance in preventing deterioration of health). The manual states that Bolivia recognises the classification rules of the GHTF (Global Harmonization Task Force), set out in the manual, and the classification is based on potential risks related to use and possible failure, combining duration of body contact, degree of invasiveness and local versus systemic effect.

Article

Numeral 1.7 and numeral 1.7.2

Conditions
  • Manufacturers classify each device according to its intended purpose; where several rules apply the highest classification is used (numeral 1.7.1(d)).
  • AGEMED may require a device to be reclassified and may consult international counterparts when studying a reclassification.
  • CIRC 43/2018 numeral 3 confirms that the risk-based classification (Clase I, IIa, IIb, III) is prioritised and that Form 027 must declare the classification matching numeral 1.7.2.

Source language: Spanish. English translation: 'Bolivia recognises the classification rules of the GHTF Global Harmonization Task Force, detailed below.'

Clinical investigation & performance

Which clinical or IVD performance evidence or study is required and accepted?

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Clinical studies are required for new moderate-high and high-risk devices

clinical.evidence-required-for-higher-risk-new-devices
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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 the product (numeral 2.4.8). The manual sets out no device-specific clinical-investigation authorisation procedure, but its legal table (numeral 1.3.6, row 28) lists the 'Norma para Estudios Clínicos' approved by Resolución Ministerial N° 0834 of 23 November 2004 among the norms of the registration framework; that norm was not read and its device reach is not asserted here.

Article

Numeral 2.4.8

Conditions
  • The obligation in numeral 2.4.8 is documentary (studies presented in the dossier), not a separate clinical-trial approval.
  • A general clinical-studies norm (R.M. 0834 of 23 November 2004) is cited in the manual's legal table; whether it establishes an ethics-committee or authorisation route for device investigations was not verified.

Source language: Spanish. English translation: '2.4.8 Efficacy and Safety: For those products classified as moderate-high risk and high risk as applicable, particularly for new products, clinical studies on use shall be presented to demonstrate the safety and efficacy of the product.'

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
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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.'

Existing insumo, miscellaneous and dental registrations are absorbed into the medical-device category

scope.insumos-and-dental-folded-into-devices
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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 granted as miscellaneous that fall within the definition of a medical device, become considered as falling in the medical-device category.

Article

Numeral 1.6, final paragraph

Conditions
  • Affects existing holders of miscellaneous registrations, who must be treated as device registrants.

Source language: Spanish. English translation: 'From this date, for harmonisation purposes and in accordance with this Manual, all companies registered in the category of insumos, miscellaneous, dental products, as well as those sanitary registrations granted as miscellaneous that fall within the definition of Medical Devices, shall henceforth be considered in the medical-device category.'

Dossier requirements

Which evidence, local deltas, formats, and signatures are required?

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Quality-system certificate (GMP or equivalent) with a two-year age limit

dossier.quality-system-certificate
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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 Manufacturing Practices or its equivalent, for every plant involved in manufacturing including conditioning or packing plants; the certificate must be no more than two years old. AGEMED may at any time require in-situ verification of the plant or request information from the regulatory authority of the country of origin about the quality system, independently of the certificate filed. For ISO certificates, AGEMED accepts a simple copy in the dossier provided it is signed and sealed by the company's legal representative and pharmaceutical regent in Bolivia as an attestation of the document's veracity.

Article

Numeral 2.3.1

Conditions
  • No consular legalisation is required for the quality-system certificate (unlike the certificate of free sale).
  • Documentation may only be submitted in the languages of pharmacopoeias recognised by Ley 1737 (CIRC 43/2018, numeral 2).
  • The in-situ verification power means the certificate does not close the quality question.

Source language: Spanish. English translation: '2.3.1 Certificate of the quality system used: The original certificate or a copy legalised by a health authority (not necessarily consularised) of the certification of the quality system used, whether Good Manufacturing Practices or its equivalent, must be submitted to the Medicines Vigilance and Control Area, a photocopy of which must be included in the dossier for all plants participating in manufacture, including those conditioning or packing the device, and it must be no more than two years old.'

Physical samples are required only for low-risk (Class I) devices

dossier.samples-required-for-low-risk-only
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Statement

Submitting samples to AGEMED with the dossier is a requirement for the issuance of the registration for low-risk medical devices. For moderate-risk, moderate-high-risk and high-risk devices, submitting a sample is not a requirement, although AGEMED may verify the products at any time in the company's or institution's warehouses.

Article

Numeral 2.6

Conditions
  • Applies to medical-device registration dossiers; the general DS 25235 dossier for medicines requires a sample (Art. 12(l)).

Source language: Spanish. English translation: 'The presentation of samples to the Directorate of Medicines and Health Technology together with the dossiers is a requirement for the issuance of the sanitary registration, for low-risk medical devices. For medical devices of moderate-low risk, moderate-high risk and high risk, the presentation of a sample is not a requirement, however the Directorate may verify the products at any time in the warehouses of the company or institution.'

Economic-operator roles

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

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Every commercial package must identify the company that markets the device in Bolivia

operator.marketer-identification-on-label
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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 product, and the design or format of that marking must be included in the registration dossier.

Article

Numeral 2.5.1(d)

Conditions
  • Applies to both imported and nationally manufactured devices.

Source language: Spanish. English translation: 'd) Marketing responsible: Pursuant to Art. 149 of D.S. 25235 every commercial package of a product must include the sticker, seal, label or imprint identifying the company that markets the product, whether imported or national, and the design or format thereof must be included in the dossier.'

The Registro Sanitario belongs to the manufacturer or licensor, not to the company that filed it

operator.registro-belongs-to-manufacturer-or-licensor
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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 manufacturer of the product, and it may be used only by accredited legal representatives.

Article

Numeral 3.2.1

Conditions
  • Corresponds to Article 19 of DS 25235 for products generally.
  • Practical effect: changing the Bolivian importer or representative does not of itself require a new registration, but the representative must be accredited.

Source language: Spanish. English translation: 'Property: It must be considered that the Sanitary Registration Certificate does not necessarily belong to the company that carries out the registration procedure, but on the contrary belongs to whoever holds the licence or is the manufacturer of the product.'

A qualified technical regent must sign the application as a declaration of veracity

operator.technical-regent-qualifications
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Statement

The application dossier must contain Form 027 in original plus two copies, completed by typewriter and signed and sealed by the company's legal representative and by the accredited regent or technical responsible — who may be a pharmacist, pharmaceutical chemist, physician, biomedical engineer, industrial engineer, electronic engineer, mechanical engineer or chemical engineer — as a declaration of the veracity of all documentation presented.

Article

Numeral 2.1

Conditions
  • The same professional profile is required for opening a device importing firm (Form 096).
  • The regent's appointment and any change of regent must be notified to AGEMED.

Source language: Spanish. English translation: 'Every dossier to be submitted must contain the Application Form for Sanitary Registration of Medical Devices, DINAMED Form 027, to be obtained from the Directorate of Medicines and Health Technology in original and 2 copies, and must be submitted typewritten, signed and sealed by the Legal Representative of the company and the accredited regent or technical responsible (pharmacist, pharmaceutical chemist, physician, biomedical engineer, industrial engineer, electronic engineer, mechanical engineer, chemical engineer) as a declaration of the veracity of all documentation presented.'

Establishment, import & distribution

Which establishment licences, importer permissions, and distribution controls apply?

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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
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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.

Fee for evaluation and inspection on opening a medical-device importing firm

fees.importer-authorisation-inspection
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Statement

The AGEMED form listing the requirements for opening a medical-device importing firm states the registration cost as item 34, 'Firmas Importadoras de Dispositivos Médicos — Evaluación e Inspección por apertura', Bs 4.964, in compliance with Resolución Ministerial N° 265.

Article

Item 34

Conditions
  • The same form states the cost is levied 'En cumplimiento de la Resolución Ministerial N° 265'.
  • The scanned fee schedule shows the same row with an OCR-ambiguous leading digit; the value in this readable official form (Bs 4.964) is preferred.

Source language: Spanish. English translation: 'REGISTRATION COST: In compliance with Resolución Ministerial N° 265. Item No. 34 — Firms importing Medical Devices, Evaluation and Inspection on opening — Bs.- 4.964.'

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

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IFU and operation, maintenance and installation manuals must be in Spanish

label.ifu-and-manuals-in-spanish
Fact-level verified
Statement

Where the device or biomedical equipment carries operation, maintenance or installation manuals, they must contain sufficient information to ensure proper execution of the procedure and safe use, in Spanish. The manuals must accompany the device; in special cases the instructions for use may be given on the secondary packaging or in an operating manual, and for biomedical equipment the operation, maintenance and installation manuals form part of the technical-scientific information.

Article

Numeral 2.7

Conditions
  • The requirement is that the manuals be in Spanish; the AGEMED requirements list for biomedical equipment additionally requires the manuals in the language of origin and in Spanish (see the equipment requirements list, item 3).
  • Content duties include contraindications, warnings and precautions, installation verification, preventive-maintenance nature and frequency, calibration, sterilisation, final assembly, environmental precautions and disposal.

Source language: Spanish. English translation: 'When the medical device or biomedical equipment carries any of these manuals, they must contain sufficient information to ensure the proper execution of the procedure and its safe use, in Spanish, and must contemplate the following aspects: a) The manuals must be with the medical device; in special cases the instructions for use may be given on the secondary packaging or in an operating manual...'

Labels in several languages are accepted provided one of them is Spanish

label.multilingual-labels-accepted-spanish-mandatory
Fact-level verified
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 date where applicable, manufacturer name and special legends; the marketer identification is added under Article 149 of DS 25235. AGEMED accepts the Spanish use information and special legends being added by insert, adhesive sticker where applicable, or package insert, while the minimum content of numeral 2.5.1(c) must be printed.

Article

Numeral 2.5.1(b) and (c)

Conditions
  • Labels must be filed in the dossier in unfolded original form (numeral 2.5.1 chapeau).
  • For device dossiers, only the languages of pharmacopoeias recognised by Ley 1737 are accepted for the rest of the documentation (CIRC 43/2018, numeral 2); the multilingual latitude in 2.5.1(b) applies to labels and markings.
  • CIRC 42/2023 clarifies that the manufacturer name and/or logo of the manufacturing or licensing laboratory and the manufacturer's country of origin must appear on primary and secondary packaging and labels, including for third-party ('PARA') manufacture.

Source language: Spanish. English translation: 'b) Labels and markings with wording in several languages will be accepted provided one of them is Spanish. c) Labels and markings must include at least the following information: Product name; Lot or serial number; Expiry date where applicable; Manufacturer name; Special legends.'

Manufacturer PMS

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

Compare countries

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.

Start-of-commercialisation notification and the other mandatory ongoing notifications for a registered device

pms.start-of-commercialisation-and-ongoing-notifications
Fact-level verified
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 begins; when it decides not to continue commercialising the product it must inform that Directorate within no more than 20 working days so that the device's Registro Sanitario can be cancelled. The same Directorate must also receive, within a peremptory 15 working days and free of charge, a notification letter with supporting documentation for: the referral sale price of each product five days before the start of commercialisation or a price change; any change of regent or technical responsible (within 15 days); any partial or total, temporary or definitive closure of the company (5 days in advance); and any change of domicile, on form DINAMED Form. 003 (within 5 days of the change).

Article

Numerales 3.1.6, 5.9 and 5.9.1-5.9.5

Conditions
  • The notifications are expressly free of charge ('sin costo alguno').
  • Numeral 3.1.6 sets the 20-working-day deadline for informing that the product will not continue to be commercialised; numeral 5.9.1 requires the start-of-commercialisation notification to be filed before commercialisation of each and every registered product, in order to determine the universe of devices available on the national market.
  • Numeral 5.8.1 provides that the list of registered medical devices contemplated for renewal includes only products whose start of commercialisation has been notified.
  • A related price and stock reporting regime now also runs through the 'AGEMED VIRTUAL' platform under RA 20/2023 (see pms.price-and-stock-reporting-including-devices).
  • The manual is a device-specific instrument; the notification duties are addressed to 'el Titular' of a Registro Sanitario de Dispositivo Médico.

Source language: Spanish. Status raised from source-backed-partial to official-source-verified on 2026-09-16 by reading T-N-35 as text and quoting the operative numerals verbatim, which the earlier row paraphrased. The manual's approval date is given inconsistently in the record (its published file name is T-N-35-RM-00113-BGM, while the r204 source title records R.M. N° 0010 of 17 January 2006); no effectiveFrom is asserted here for that reason, and the instrument is cited by its T-N-35 code.

Official forms & portals

Which current form, portal, account, and submission package must be used?

Compare countries

Form 027 is the official device registration application form

forms.form-027-device-application
Fact-level verified
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 (inscription, reinscription, rectification, change, sanitary registration, commercialisation permit), whether the device is imported or national, the applicant company and its ministerial resolution and accredited professional, the manufacturer and licence and country of origin, and the product data (commercial and generic name, risk classification, international code, whether installation/operation/maintenance manuals are included, indications or use, presentation, storage and packaging, shelf life and disposal method).

Article

FORM. 027

Conditions
  • The form must be filed in original plus two copies, signed and sealed by the legal representative and the technical regent (manual numeral 2.1).
  • CIRC 43/2018 requires the classification declared on Form 027 to match numeral 1.7.2 of the manual.

Source language: Spanish. The form's own field labels are: 'SOLICITUD PARA REGISTRO DE DISPOSITIVO MÉDICO - EQUIPO', 'Tipo de Trámite: Inscripción / Reinscripción / Rectificación / Cambio / Registro Sanitario / Permiso de comercialización / Origen: Importado / Nacional', 'Clasificación de acuerdo al riesgo', 'Código Internacional'.

QMS, audit & inspection

Which QMS, audit, inspection, and certificate scope is accepted or required?

Compare countries

AGEMED may verify the manufacturing plant in situ or request information from the origin regulator

qms.in-situ-verification-and-origin-authority-requests
Fact-level verified
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 the regulatory authority of the country of origin on compliance with the quality system used.

Article

Numeral 2.3.1, second paragraph

Conditions
  • This power is what makes the GMP/ISO certificate evidentiary rather than conclusive.
  • DS 2905 Art. 7(f) gives AGEMED the function to inspect, monitor and audit manufacturers, importers and wholesalers.

Source language: Spanish. English translation: 'It must be taken into account that the DINAMED may at any time require in-situ verification of the plant or request from the Regulatory Authority of the country of origin information or reports on compliance with the quality system used, independently of the certification presented.'

Recall, FSCA & market surveillance

Which recall, FSCA, notice, and authority-coordination duties apply?

Compare countries

Batch-withdrawal classification (Clase I/II/III) and the deadlines for executing a withdrawal of one or more batches

recall.publication-of-withdrawn-lots-and-classification
Fact-level verified
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 classification fixes the deadline by which the company must complete the withdrawal: Clase I (a reasonable probability that use of or exposure to the batch will cause serious adverse health consequences or death) — 72 hours; Clase II (use of or exposure to the batch may cause adverse health consequences that are temporary or medically reversible, or where the probability of serious adverse health consequences is remote) — one month; Clase III (use of or exposure to the batch does not appear to cause adverse health consequences) — three months. Where a Registro Sanitario or an active principle is cancelled, the market withdrawal is likewise graded by seriousness and must be completed by the company within 72 hours, three months or nine months, as the case may be.

Article

Numerales 6.13.1 and 6.14

Conditions
  • DEVICE SCOPE: numeral 3.1 (Alcance) applies the System to everyone engaged in the manufacture, importation, storage, distribution, dispensing, sale, donation or commercialisation of the products contemplated by Ley 1737 Art. 4 and lists them, and that list expressly includes 'Dispositivos médicos' (alongside Medicamentos especiales, Biológicos, Hemoderivados, Dietéticos, Odontológicos, Cosméticos, Radio fármacos); the device manual T-N-35 numeral 5.11 likewise states the System applies 'a todos los medicamentos reconocidos por Ley, incluyendo dispositivos médicos'. No device-specific batch-withdrawal instrument was found.

Effective from 2003-05-14

Ley del Medicamento N° 1737 de 17 de diciembre de 1996

Source language: Spanish. Status raised from source-backed-partial to official-source-verified on 2026-09-16 by reading the Sistema Nacional de Vigilancia y Control de Medicamentos (AGEMED technical norm T-N-19, R.M. N° 0250 of 14 May 2003) as text and quoting the operative numerals, which the previous row recalled rather than reproduced. DISPOSITION OF THE PREVIOUS ROW'S SECOND LIMB: the earlier value also asserted that AGEMED 'will issue communications through its official platforms' naming cancelled products and warning of contraband, falsification and unauthorised commercialisation. That limb came from Circular MSyD/AGEMED/CR/1/2026, which is published only as an image-only scan (3 pages, HP Scan creator, no embedded fonts, every page a JPEG) and was not OCR'd here; it is therefore not carried into this verified value, and no verified Bolivian instrument imposing a publication-of-withdrawn-lots duty was located.

Who must execute a batch withdrawal, the written-procedure duty, and the contents of the withdrawal report to the authority

recall.withdrawal-execution-and-report-contents
Fact-level verified
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 by the legal representative or manufacturer and must be carried out at the various levels of distribution according to the seriousness of the defect or problem with the product. Because withdrawal is the responsibility of the legal representative — whether an industrial pharmaceutical laboratory, an importer or a national distributor — every company must maintain written procedures setting out its product-withdrawal policy and must make them known to the DINAMED authorities. The Dirección de Medicamentos y Tecnología en Salud must be informed of every withdrawal, and may call on authorised governmental or non-governmental bodies to assist; inspectors may verify the withdrawal process at any time for faithful compliance, together with the report stating the batch number, the number of units making up the batch, the total units withdrawn, the cause that determined the withdrawal of the batch, and the corrective and preventive measures adopted. The Directorate may also order a withdrawal, stating its reasons, on alerts received from recognised international bodies, national or international authorities, or manufacturers in other countries (whether of raw material or finished product), or on results received from the Laboratorio de Control de Calidad de Medicamentos y Toxicología (CONCAMYT).

Article

Numeral 6.13

Conditions
  • Device reach follows the same chain as recall.publication-of-withdrawn-lots-and-classification: numeral 3.1 incorporates the products contemplated by Ley 1737 art. 4, which in literal (g) includes 'dispositivos médicos, substancias para diagnóstico y reactivos para laboratorio clínico' among the 'Medicamentos especiales'.
  • The instruments are drafted for medicines; no device-specific withdrawal-report form was located, and the report contents above are those the instrument requires of the marketing-authorisation holder generally.
  • The final step of the instrument's withdrawal regime is destruction: numeral 6.13.1 provides that the withdrawn batch is to be incinerated, as the case may be, under the responsibility of the product's legal representative.

Effective from 2003-05-14

Ley del Medicamento N° 1737 de 17 de diciembre de 1996

Source language: Spanish. This is a new key, added because the report-contents and written-procedure duties are a distinct operative rule from the classification and deadlines already recorded in recall.publication-of-withdrawn-lots-and-classification.

Registration pathways

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

Compare countries

Biomedical equipment may be placed through a Certificado de Comercialización instead of a full Registro Sanitario

pathway.biomedical-equipment-commercialisation-certificate
Fact-level verified
Statement

For medical devices considered biomedical equipment, AGEMED issues 'Certificados de Comercialización' that recognise a declaration made by the manufacturer or the Bolivian representative, covering that the equipment is not under experimentation, that spares and maintenance can be supplied for five years or the equipment's useful life, that operator training will be provided, and that operation, installation and maintenance manuals in Spanish will be supplied. AGEMED resumed issuing these certificates and set a maximum issuance time of 5 working days from filing on the MISA platform, on payment of the service fee.

Article

Numeral 1

Conditions
  • The certificate recognises a declaration by the Bolivian representative; it is a modality of Registro Sanitario but a lighter one than the full device dossier.
  • Issuance is through the MISA platform and requires prior payment of the fee fixed by Resolución Ministerial N° 0265 de 25 de mayo de 2018.
  • Circular 86/2023 records that the practice was 'retomado' (resumed), so there was a gap in issuance before 2023.

Source language: Spanish (scanned circular, read via OCR). English translation: 'Pursuant to numeral 2.9.2 of the Manual for Sanitary Registration of Medical Devices approved under Resolución Ministerial N° 0010 of 17 January 2006, AGEMED shall issue "Certificates of Commercialisation" for biomedical equipment, through which the declaration made by the representative in Bolivia is recognised.'

A listed set of low-risk articles is exempt from Registro Sanitario

pathway.devices-exempt-from-registration
Fact-level verified
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 pillows, safety eyewear, balances, hospital beds, stretchers, carts, cushions, bedpans, laboratory aprons, dispensers, exercisers, X-ray shields, sheets, chairs, stools, slippers), subject to permanent and periodic review; companies must still report the commercialisation of those products to AGEMED. Numeral 7 of the same circular, which confined the 'certificados de comercialización' service to devices on that list, was left without effect by Circular MSyD/AGEMED/CR/86/2023 numeral 9 (13 December 2023), which applies item 140 of Resolución Ministerial N° 0265/2018 ('otras certificaciones no especificadas') to such certifications instead.

Article

Numerales 5 and 7

Conditions
  • The annex is fully legible in the scanned copy and lists 133 articles by ECRI-style code and Spanish/English name.
  • Exempt devices still require the companies to report their commercialisation to AGEMED.
  • Circular 86/2023 numeral 9 revoked numerals 6 and 7 of Circular 43/2018; only numeral 5 and the annexed list remain operative from this circular.

Effective from 2018-12-03

Source language: Spanish (scanned circular, read via OCR). The numbered item is quoted verbatim; the illustrative device names come from the partly legible annex, so the fact is weighted source-backed-partial. English translation: 'The medical devices contemplated in the attached list shall not be subject to Sanitary Registration, this being subject to permanent and periodic review.'

Registration modalities and one registration per device group

pathway.registration-modalities-and-grouping
Fact-level verified
Statement

The modalities that require a Registro Sanitario are: manufacture and market, import and market, import, import and pack and market, import, semi-process and market, import, assemble and market, manufacture and export, and import, condition and market. Devices are registered by group — one Registro Sanitario for each group — using the grouping table in Anexo 2 of the manual.

Article

Numeral 1.5 and Capítulo II chapeau

Conditions
  • Equipo biomédico follows a different route (Certificado de Comercialización) rather than the standard import modality.

Source language: Spanish. English translation: 'This Registration Manual generally establishes the requirements, procedures, instructions and forms for all medical devices that fall within the definition of Medical Device cited below, the modalities requiring a Registro Sanitario being: manufacture and market; import and market; import; import, pack and market; import, semi-process and market; import, assemble and market; manufacture and export; import, condition and market.'

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?

Compare countries

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 (6 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

BoliviaSource authority not specified

Prior approval / evidence record

Certificate of free sale from the country of origin is mandatory dossier evidence for imported devices

reliance.origin-country-free-sale-certificate
Fact-level verified
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 the product is duly authorised there, legalised by a Bolivian consulate, and where the origin country has no Bolivian consular representation, certified by Bolivia's Ministry of Foreign Affairs together with the original document. This is a mandatory element of the local dossier and does not shorten or replace the local evaluation.

Source Approval

Registration/marketing authorisation of the device by the competent national health authority of the country of origin (any country of origin; no specific authority is named)

Edge Type

Origin Country Evidence

Market Access Strength

Evidence Only

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Applies to imported devices; a domestically manufactured device files no free-sale certificate.
  • The certificate must be legalised by a Bolivian consulate; if the origin country has no Bolivian consular representation, a certification from the Ministerio de Relaciones Exteriores y Culto de Bolivia plus the original document is accepted instead.
  • If the certificate states no validity, it is valid for the term of the Registro Sanitario expressed in it, or for two years from issue if no term is specified.
  • Article 14 of DS 25235 imposes the same origin-country certificate requirement in general terms, referring to the WHO model certificate for pharmaceutical products in international commerce.
  • A device whose origin country has not authorised it cannot satisfy this requirement, so a device approved only outside its country of origin is not registrable.

Source language: Spanish. English translation: 'Certificate of Free Sale: For imported products, the medical device certificate must be presented, stating that the product in question is duly authorised in the country of origin. The certificate must be endorsed by the competent National Health Authority and legalised by a Bolivian Consulate, taking into account the following exceptions: a) A certificate that does not state its validity shall be valid according to the validity of the Registro Sanitario expressed in it, or for two years from its date of issue where none is specified; b) Where the country of origin has no Bolivian consular representation, the corresponding certification from the Ministry of Foreign Affairs and Worship of Bolivia must be presented together with the original document issued by the competent health authority of the country of origin.'

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.'

Review clocks

What review, validation, and applicant stop-clock rules apply?

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Biomedical-equipment Certificado de Comercialización issued within 5 working days

clocks.commercialisation-certificate-five-working-days
Fact-level verified
Statement

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.

Article

Numeral 4

Conditions
  • Requires prior payment of the fee fixed by Resolución Ministerial N° 0265 de 25 de mayo de 2018.
  • Applies to biomedical equipment, not to the standard device dossier.

Source language: Spanish (scanned circular, read via OCR). English translation: 'Once the procedure has entered through the MISA Platform, the time established for issuing the Certificates of Commercialisation shall not exceed 5 working days.'

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.'

Observed dossiers have 60 calendar days to remedy; rejected dossiers may re-enter within 60 calendar days on payment

appeal.rejected-dossier-reentry-and-observation-period
Fact-level verified
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 days by submitting the corresponding documentation together with the note received; the file is returned to the interested party only in exceptional cases and on written request. Where the dossier is rejected for missing documents, it is returned to the interested party and may re-enter for a second evaluation within no more than 60 calendar days, attaching a copy of the payment order for the second evaluation.

Article

Numeral 3.1.4(b) and (c)

Conditions
  • The second evaluation requires payment (item 102 of the AGEMED tariff, second evaluation for registration, 621).
  • After the observation period expires without a response, AGEMED may reject the application.

Source language: Spanish. English translation of 3.1.4(b): 'Observed: Should any remediable technical observation arise, a note shall be given to the interested party detailing the observations, which must be remedied by the interested party within 60 calendar days by submitting the corresponding documentation with the note received from the Directorate of Medicines and Health Technology.'

UDI, listing & traceability

Which UDI, device listing, database, and traceability duties apply?

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Traceability is by lot coding and, for biomedical equipment, by serial number and installation site

traceability.lot-coding-and-equipment-serial-reporting
Fact-level verified
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 interpretation in the dossier, and, for biomedical equipment, notification to AGEMED of the health establishments where the equipment will be installed and an annual report of the quantity of equipment imported, manufactured and sold, with each equipment's serial number and its geographic and institutional location.

Article

Numerales 2.4.6 and 2.9.1

Conditions
  • The label must carry the lot or serial number and the expiry date where applicable (numeral 2.5.1(c)).
  • AGEMED publishes quarterly the list of devices holding a valid registration, limited to products whose start of commercialisation has been notified (numeral 5.8.1).

Source language: Spanish. English translation: 'The holder responsible for the commercialisation of biomedical equipment must report annually the quantity of equipment imported, manufactured and sold, the serial number of each equipment, and its geographic and institutional location.' The absence of a UDI system is a negative finding from the same manual and the current requirements list, so this element is weaker than the quoted duty.

Vigilance & incident reporting

What is reportable, by whom, where, in what format, and by what deadline?

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AGEMED may cancel a device registration during its validity on three grounds

vigilance.cancellation-grounds
Fact-level verified
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 approved parts and components that were not notified, or where after a review of alerts AGEMED resolves by minute to issue a cancellation resolution. The National System for Vigilance and Control of Medicines applies to medical devices for these purposes.

Article

Numeral 5.11

Conditions
  • Cancellation is distinct from rectification: substantial un-notified changes in approved parts and components lead to cancellation.
  • The alerts-review ground gives AGEMED a unilateral cancellation power.

Source language: Spanish. English translation of ground (b): 'If substantial changes are verified in the parts and components approved for the Sanitary Registration, which have not been notified to the Directorate of Medicines and Health Technology.'

Withdrawal after cancellation is executed within 72 hours, three months or nine months according to health severity

vigilance.market-withdrawal-timeframes-by-severity
Fact-level verified
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, within 72 hours, three months or nine months, as the case may be.

Article

Numeral 5.11.1

Conditions
  • The deadline is imposed on the company; failure to execute is itself a reportable recall scenario (see CIRC 1/2026).

Source language: Spanish. English translation: '5.11.1 Timeframes: When a Sanitary Registration is cancelled, according to the severity in health terms, the withdrawal of the product from the market shall be established, under the responsibility of the company, within 72 hours, three months or nine months, as the case may be.'

Related structured datasets

Classification systems · 1 record
Open Clases I, IIa, IIb y III — reglas de clasificación GHTF del Manual para Registro Sanitario de Dispositivos Médicos →
Id

bolivia:medical-device

Jurisdiction Id

bolivia

Domains
  • medical-device
Name

Clases I, IIa, IIb y III — reglas de clasificación GHTF del Manual para Registro Sanitario de Dispositivos Médicos

Description

Bolivia's own four-class axis, set out in numeral 1.7.2 of the Manual para Registro Sanitario de Dispositivos Médicos: Class I low risk under general controls, Class IIa moderate risk with special manufacturing controls, Class IIb high risk with special design controls, and Class III the highest risk. The manual's numeral 1.6 defines the devices in scope, and it is the technical instrument that fixes the requirements and procedure for device registration; AGEMED's later circulars identify it as the operative instrument. There is no Andean Community device mutual recognition: the only automatic homologación route AGEMED operates recognises the sanitary-notification code of another Andean Community member state for cosmetic and household-hygiene products under Decisiones 516 and 706, and no equivalent instrument for medical devices exists — Bolivian registration is what actually happens.

Classes
  • Id

    i

    Label

    Clase I — riesgo bajo, controles generales

    Normalized Risk Level

    low

  • Id

    iia

    Label

    Clase IIa — riesgo moderado, controles especiales de fabricación

    Normalized Risk Level

    medium

  • Id

    iib

    Label

    Clase IIb — riesgo alto, controles especiales de diseño

    Normalized Risk Level

    high

  • Id

    iii

    Label

    Clase III — riesgo más alto

    Normalized Risk Level

    highest

Regulator

AGEMED

Official Domains
  • agemed.gob.bo
Source Status

official-source-verified

Source Title

Manual para Registro Sanitario de Dispositivos Médicos, aprobado por Resolución Ministerial N° 10 de 17 de enero de 2006, numerales 1.6 y 1.7.2 — definición de dispositivo médico y reglas de clasificación GHTF

Source Url

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

Verified On

2026-09-16

Source Supports
  • class-axis
  • classification-rules
Registration pathways, prior approvals and planning · 1 record
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
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
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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