Bolivia Form 027 Application Form: Signature and Legal Responsibility Guide

1. Key takeaways

Medical device registration in Bolivia is initiated through Form 027, the application form prescribed by the Manual para Registro Sanitario de Dispositivos Médicos. Two signatures are mandatory, and neither can be omitted or replaced by an electronic substitute: the first is the legal representative of the company, and the second is the technical director, known locally as the regente or responsable técnico. Section 2.1 of the Manual lists the professional fields from which the technical director may be drawn, covering pharmacists, biomedical engineering, electronic engineering, mechanical engineering and related disciplines. A submission that lacks Form 027 is expressly listed in Chapter 3 of the Manual as one of the grounds for rejection, which means the application can be turned away at the administrative screening stage before any technical review begins. GRZAN’s assessment is that Form 027 should not be treated as a routine administrative cover sheet. It is the document that anchors legal responsibility to specific natural persons, and the professional qualification of each signatory must match the product category being registered. A form signed by a person whose listed profession does not correspond to the device type invites reviewer observations and can compromise the validity of the entire filing. Manufacturers and importers should therefore verify both signatures, and the professional background behind them, before any dossier is assembled for submission to AGEMED. Treating this step as a pre-submission gate rather than a formality saves review cycles: an application rejected at intake for a missing or defective Form 027 consumes time that could otherwise have been spent preparing clinical and technical content.

2. Legal basis

3. Expert insights

Insight one: the technical director system is Bolivia’s design for personal accountability. Unlike many markets where regulatory responsibility rests on the corporate entity alone, Bolivia requires that a natural person with a specific professional background co-sign the application. This produces two practical consequences. First, when an importer replaces its technical director, the continuity of the registration dossier is affected, because the responsible person named on file no longer matches the person actually accountable for the product line. Second, a mismatch between professional background and product category, for example a pharmacist signing for a complex active electromedical device, can become a ground for reviewer observations even if every other document in the dossier is complete. Companies should treat the identity and credentials of the technical director as a core dossier element, not an administrative detail, and should track any change of signatory as a regulatory event with filing implications.

Insight two: the professional scope listed for Form 027 is presented as an enumerated list. Section 2.1 of the Manual directly names the occupations that may serve as technical director rather than describing general competence criteria. Because the list is closed, companies selecting an importer should check whether that importer’s technical director holds a professional background covering the target product category. In GRZAN’s experience this is a step that is frequently skipped during importer due diligence, yet it determines whether the signature on Form 027 will withstand scrutiny. A distributor whose regente is qualified for pharmaceuticals but not for biomedical equipment may be unable to lawfully support registrations for devices outside that scope.

Insight three: Form 027 operates together with the authorization information page required by Section 2.2.3. That section requires a signed page identifying who grants the power of legal representation, the period for which it is granted, the product right holder or licensor, the manufacturer, and every plant that produces, fills or packages the finished product. Form 027 and this page together constitute the chain of responsibility for the filing. If the two documents are inconsistent, for instance if a plant appears on one but not the other, reviewers may question the completeness of the authorization chain and issue observations that delay approval. Keeping the two documents aligned also simplifies later maintenance, because renewals and changes of ownership must reproduce the same responsibility chain that was accepted at first registration.

4. Practical recommendations

1. Add one item to importer due diligence: verify that the importer’s technical director holds professional qualifications covering the target product category, and obtain documentary evidence of the credential rather than relying on self-declaration.
2. Include a notification obligation for changes of technical director in distribution agreements, so that the signatory of record never lapses silently and the dossier can be updated before the change takes effect.
3. List all plants in full accordance with Section 2.2.3, including packaging sites; a submission that names only the final assembly plant will not satisfy the requirement to identify every site that produces, fills or packages the finished product.
4. Confirm both signatures on Form 027 before submission and keep copies of the identity and credential documentation of each signatory in the registration file for future reference and renewal cycles.

5. Verification checklist

• □ Form 027 is signed by both the legal representative and the technical director
• □ The technical director’s profession falls within the list in Section 2.1 of the Manual and matches the product category
• □ The information page required by Section 2.2.3 is attached to the dossier
• □ The plant list covers all production, filling and packaging sites
• □ The term of the authorization is expressly stated in the document

Regulatory information verified as of October 29, 2026.

GRZAN provides registration support in Bolivia for manufacturers, importers and authorized representatives, covering application form preparation, technical director coordination, dossier assembly and regulatory correspondence. For assistance with Form 027 and the full registration process, contact info@grzanglobal.com.