Bolivia Decreto Supremo 25235: Articles 42 and 149 Binding Devices

1. Key takeaways

Decreto Supremo N° 25235 of November 30, 1998 is the implementing regulation of the Medicines Law, and two of its articles still bind medical devices directly. Article 42 requires the importing enterprise to file with the Ministry of Health the legal representation granted by the manufacturer in the country of origin; the document must be an original, duly legalized, and must state the period of validity of the authorization. Article 149 requires every package to identify, by label, stamp, or printing, the Bolivian enterprise that sells the product, and requires the design of that identification to be included in the application dossier. GRZAN has repeatedly seen these two articles dismissed as medicines provisions in project work, yet they are precisely the points at which device dossiers are most frequently found to be missing documents. Treating them as device obligations from the outset prevents avoidable observation letters and re-filings during review.

Both articles operate at the point where the Bolivian system attaches responsibility to local actors. Article 42 anchors the foreign manufacturer to a legally represented position inside a Bolivian importing enterprise, and Article 149 makes that enterprise visible on every unit of product sold. Together they mean that the identity of the local partner is printed into the packaging itself, which raises the cost of changing importers after registration and reinforces the need to settle the commercial structure before the dossier is designed. GRZAN reviews both provisions at project intake, before any document is drafted, so that the authorization letter, the label artwork, and the dossier indexes are built around the same named enterprise from the first version onward.

2. Legal basis

3. Expert insights

Insight one: Article 42 requires the validity period to be stated, and this is the single most frequently omitted element of the letter of authorization. Many letters of authorization issued by manufacturers state the scope of the authorization but no term, or state that it is valid indefinitely. Following the wording of Article 42, the authorization document should contain the period for which the representation is granted. GRZAN recommends stating explicit start and end dates in the letter of authorization and reserving a renewal clause, so that neither the importer nor the regulator is left interpreting an open-ended grant.

Insight two: Article 149 turns the Bolivian identifier into a design documentation obligation. It does not merely require a label to be applied; it requires the design of the identification to be included in the dossier. This means the label design must be finalized before submission. A strategy of applying the identification after approval does not fit the text, and a dossier filed without the artwork will be treated as incomplete rather than as pending a later step.

Insight three: the filing under Article 42 and the filing under Section 2.3.4 of the manual are two faces of the same obligation. The manual provides that the manufacturer representation document is filed in advance, as an original, with the surveillance and control department of AGEMED, and that no consular legalization is required; Article 42 confirms the legal representation filing requirement at the level of the implementing regulation. The two texts echo each other, but the manual adds one operational convenience: the representation document does not need to be resubmitted with every dossier. Knowing where each requirement comes from helps when responding to reviewer observations that cite one text but not the other.

Insight four: the two articles also discipline distributor changes. Because Article 149 puts the name of the selling enterprise on the package and Article 42 files the representation with the ministry, a change of importer is not a purely commercial event: the label, the dossier references, and the representation filing are all attached to the outgoing entity. Planning the representation document and the label design so that they can be updated without redrawing the entire packaging is a design decision that belongs in the first artwork round, not in a crisis response months after approval.

4. Practical recommendations

The recommendations below convert the two provisions into project checkpoints. They assume the standard sequence of a Bolivian device program: the authorization letter is negotiated while the dossier is drafted, the label artwork is finalized in parallel with the technical documentation, and the representation filing is completed before the first submission. Keeping that sequence visible on the project plan prevents the two most common failure modes seen in practice: a dossier filed with an undated authorization letter, and an artwork file that reaches the printer before the Bolivian selling enterprise has been finally confirmed.

1. Three mandatory elements in the letter of authorization: grantor and grantee, scope of the authorization (registration, import, distribution), and explicit start and end dates of validity.
2. Move label design upstream: include the identification of the Bolivian selling enterprise in the packaging design review gate, completed in the same batch as the Spanish-language label.
3. File the representation document before the first submission: do not discover on the filing date that the representation document has not yet been registered with AGEMED.

5. Verification checklist

• □ Does the letter of authorization state explicit start and end dates of validity
• □ Has the authorization document been filed as an original with the surveillance and control department of AGEMED
• □ Does the packaging artwork include the identification of the Bolivian selling enterprise
• □ Has the design of this identification been included in the application dossier
• □ Does the letter of authorization require an apostille or consular legalization (confirm the current interpretation with AGEMED)

Regulatory information verified as of October 29, 2026.

GRZAN supports manufacturers, importers, and authorized representatives with medical device registration in Bolivia, covering dossier preparation, local entity coordination, and regulatory strategy. Contact info@grzanglobal.com for project inquiries.