When a manufacturer asks me about Bolivia, the first surprise is how old the rulebook is. AGEMED still runs device registration on a manual written when the regulator was called DINAMED, and Bolivia’s official procedures portal cites that manual today as the legal basis for the filing. The second surprise is in Section 3.2.1 of that manual: the registration certificate doesn’t necessarily belong to the company that files it.
I am Julio Martinez-Clark, CEO of bioaccess®. This page explains how to get a device that is already FDA-cleared or CE-marked onto the Bolivian market through the Agencia Estatal de Medicamentos y Tecnologías en Salud (AGEMED). It sits alongside our LATAM market-access hub, the Bolivia AGEMED country page and the Importer of Record guide. If you are planning a first-in-human study in Bolivia rather than a launch, start with our Bolivia CRO page. This is operator guidance, not a quote and not legal advice.
One-sentence answer
Bolivia registers medical devices under Ley 1737 (Ley del Medicamento, 17 December 1996), its regulation Decreto Supremo 25235 (30 November 1998) and AGEMED’s Manual para Registro Sanitario de Dispositivos Médicos. A Bolivian company authorized by Resolución Ministerial files Form 027 through AGEMED’s virtual procedure, with one registration per device group, a 30-business-day issuance target and five-year validity.
The rule that governs the file
The manual’s objective (Section 1.2) ties it to Ley 1737, DS 25235 and Decreto Supremo 26873 (the Sistema Nacional Único de Suministro). On Bolivia’s official procedures portal, gob.bo, procedure 82 (registration of an imported medical device) lists its legal basis as Resolución Ministerial 0265 of 25 May 2018 and the device manual approved by Resolución Ministerial 010. It is a virtual procedure with AGEMED as the responsible agency.
One citation detail matters if you are writing an SOP. Resolución Ministerial 0909 of 7 December 2005 approved the general Manual para Registro Sanitario, which gob.bo uses for medicines. The device manual is a separate document. If your consultant memo cites RM 0909 as the device rule, ask them to check it.
Classification follows GHTF rules
Section 1.7 sets four risk classes: I (low), IIa (low-moderate), IIb (high-moderate) and III (high). Section 1.7.2 says Bolivia recognizes the Global Harmonization Task Force classification rules and reproduces all 16 of them, covering non-invasive, invasive and active devices plus the special rules for medicinal substances, tissues, disinfection and contraception. When more than one rule applies, the highest class wins (1.7.1 d). The manual also lets AGEMED reclassify a device based on post-market experience.
You declare the class yourself. Item 2.4.7 says that if the class isn’t on your certificate of free sale, you state the class the manufacturer assigned.
One registration per group
Chapter II opens with a rule many foreign teams miss: devices are registered by group, one registration per group, using the grouping in Annex 2. Annex 2 splits devices into non-invasive, invasive and active families, then numbered groups within each (for example, osteosynthesis implants and joint prostheses together in one invasive group). Section 5.10.2 lets you add items to an existing registration as a rectification, but only if they share the same risk class and group. Map your catalogue to Annex 2 before you count how many filings you need.
Who can file
The applicant is a Bolivian establishment, not the foreign manufacturer. The file needs:
- A copy of the Resolución Ministerial authorizing the company to operate (2.2.1).
- A current Certificado de Empresa confirming its license, annual re-registration and annual inspection, whether it’s a manufacturer or an importer (2.2.2). Section 5.7.2 requires every company to re-register each year by 31 December.
- Form 027, signed by the company’s legal representative and by its regente or technical responsible person. The manual lists the professions that can act as technical responsible, from pharmacist to biomedical, electronic or mechanical engineer (2.1).
- A signed sheet naming who granted the legal representation and until when, the product owner or licensor, the manufacturer and every plant that makes, fills or packs the finished product (2.2.3).
The manufacturer’s representation document isn’t refiled with every dossier. Section 2.3.4 says it is lodged beforehand, in original, with AGEMED’s vigilance and control area, and that it doesn’t need consularization.
Who owns the registration
Section 3.2.1 is the most important paragraph in the manual for a foreign manufacturer. It says the registration certificate does not necessarily belong to the company that processes it; it belongs to whoever holds the product license, or to its manufacturer.
That gives you a starting point in negotiations, not a guarantee. Your Bolivian importer still holds the operating license, signs Form 027 and appears on the file. Put the ownership language from 3.2.1 into your distribution agreement, together with an obligation to cooperate on any change of company. Have local counsel review it before the first filing.
What an imported device has to file
- Quality-system certificate (2.3.1). GMP or an equivalent quality-system certificate, in original or a copy legalized by the health authority (the manual says not necessarily consularized). You need one for every plant, including packaging plants, and it must be no more than two years old. AGEMED can still inspect the plant or ask your home regulator about it.
- Certificate of free sale (2.3.2). It must be issued or endorsed by the national health authority of the country of origin and legalized by the Bolivian consulate. Where there is no Bolivian consulate, you present the original with a certification from Bolivia’s Ministry of Foreign Affairs. If the certificate states no validity, it’s accepted for two years from issuance. Bolivia joined the Hague Apostille Convention on 7 May 2018, after this text was written, so confirm with AGEMED whether an apostille is accepted in place of consular legalization for your document. Our certificate of free sale post explains why devices that are not yet cleared at home stall here.
- Technical file (2.4). Parts and components, a certificate of analysis or design verification and validation report, shelf life, storage conditions, an international nomenclature code (ECRI, GMDN or equivalent), lot coding, risk class, instructions-for-use summary, sterilization method and disposal method.
- Clinical evidence (2.4.8). For high-moderate and high-risk devices, particularly new products, the file includes clinical studies supporting safety and efficacy.
- Labels (2.5). Multilingual labels are accepted if one language is Spanish. Minimum content is product name, lot or serial number, expiry where applicable, manufacturer and special warnings. Under Article 149 of DS 25235, every package also carries a sticker, stamp or print identifying the Bolivian company that sells it, and the file includes its design.
- Manuals (2.7). Operating, maintenance and installation manuals must be in Spanish.
- Samples (2.6). Samples are required only for low-risk devices. For the other classes, AGEMED can verify product at the company’s warehouse at any time.
Biomedical equipment has an extra declaration (2.9). The manufacturer or Bolivian representative states that the equipment is not experimental, that spare parts and maintenance are available for five years (or the equipment’s life, if shorter), that training is offered, and that manuals are supplied in the original language and Spanish. The holder also reports installed units and their locations every year.
How the review runs
Chapter III sets the sequence: pay the service fee, get the payment order, file the dossier, and AGEMED evaluates. The current gob.bo procedure describes the same steps, with the documents loaded through AGEMED’s MISA platform. There are three outcomes:
- Approved. AGEMED issues the registration with a DI code for imported devices (DN for national ones).
- Observed. You get a note listing correctable technical observations and have 60 calendar days to answer them.
- Rejected. Missing core items, such as Form 027, the company documents, the parts description or labels, mean rejection. You can refile for a second evaluation within 60 calendar days, with a new payment.
Section 3.1.5 says the certificate is delivered within 30 business days of filing, valid for five years. Treat that as AGEMED’s clock for a clean file, not your end-to-end plan: consular or apostille steps, translations and any observation round come on top. Appeals of a rejection go to AGEMED’s quality-assurance committee with a technical justification (5.4).
After approval
- Registration number on pack (5.7.1). The number has to be printed, stamped in indelible ink or applied as a sticker in a visible place.
- Notifications (5.9). Notify AGEMED before marketing starts (the manual’s notifications carry a 15-business-day deadline). Also send a reference sale price before launch or a price change, and notify changes of technical responsible, closures and address changes.
- Changes (2.10 and 5.10). Non-substantial changes, such as secondary components, packaging, labels, design, power source, manufacturing process, shelf life or company name, are rectifications that keep the original number and validity.
- Renewal (3.1.7). File in the three months before expiry. The manual gives a short tolerance after expiry, but late renewals are charged as a new inscription.
- Cancellation (5.11). AGEMED can cancel a registration for undisclosed substantial changes or after an alert review, with market withdrawal at 72 hours, three months or nine months depending on the risk.
What this file is not
- It is not a clinical-trial authorization. FIH study approval runs on a separate track; see our Bolivia CRO page.
- It is not part of the bioaccess® fixed-price market-access subscription. That subscription covers only multi-importer countries plus Argentina. Bolivia is quoted as scoped, manufacturer-funded processing.
How bioaccess® runs Bolivia registrations
bioaccess® processes AGEMED registrations funded by the manufacturer. That covers Annex 2 grouping and classification, the Chapter II dossier, the legalization and translation plan, the filing, agency liaison and post-approval notifications. Local counsel reviews your representation document and distribution agreement so that ownership and control stay where you intend them. AGEMED sets its own service fees, and we confirm scope and pricing at proposal. Details: bioaccessla.com/market-access/bolivia-agemed.
Operator checklist
- Cite the device manual and gob.bo procedure 82 (RM 0265/2018, RM 010), not RM 0909, in your SOPs.
- Map your catalogue to the Annex 2 groups before you count filings.
- Choose a Bolivian importer with a current Certificado de Empresa and a technical responsible who can sign Form 027.
- Write the Section 3.2.1 ownership language into the distribution agreement.
- Get quality-system certificates under two years old for every plant, and plan legalization of the certificate of free sale early.
- Prepare Spanish labels, manuals and the Bolivian seller sticker before filing.
- Calendar renewal for the three months before the five-year expiry.