Bolivia Medical Device Registration: Power of Attorney Scope, Plant Lists and Transfer Clauses

1. Key takeaways

Section 2.2.3 of the manual requires a signature page stating who confers legal representation and until when, the product rights holder or licensor, the manufacturer, and every plant where the finished product is produced, filled or packed. Read with the requirement in Article 42 of Decreto Supremo N° 25235 that the period of validity be stated, the elements that a power of attorney must contain come to five: the grantor and the grantee, the scope of the grant (registration, import, distribution), an express validity period, the product rights holder together with all manufacturing plants, and transfer and termination clauses. The last of these is not a manual requirement, but it is a practical necessity for protecting the manufacturer.

The reason the fifth element matters is that a power of attorney is the legal instrument through which one company acts in the name of another before a regulator. Its terms determine what the holder can do, for how long, and what happens when the commercial relationship ends. A power drafted only to satisfy the filing checklist will satisfy the regulator and leave the manufacturer exposed, because the document that grants authority is also the document that defines the limits of that authority.

Bolivia is a market where this distinction is felt acutely, since the same document supports the registration, the import chain and the vigilance channel. Getting the scope right at the outset is cheaper than amending it under pressure later.

2. Legal basis

The four provisions define the instrument from the inside out. Section 2.2.3 determines the content of the signature page and the identity details that must appear on it; Article 42 adds the validity element and the obligation to register the representation with the Ministry of Health; section 3.2.1 supplies the ownership principle that gives the manufacturer a claim over the registration itself; and section 2.3.4 governs how the representation document is filed with AGEMED. A power of attorney that satisfies section 2.2.3 but says nothing about transfer will pass the filing desk and still fail the manufacturer at the point where it needs to change partner.

3. Expert insights

Insight 1: the scope of the grant should be sufficient and no wider. GRZAN recommends limiting the powers in a power of attorney to matters connected with regulatory filing: submission, responses to requests for correction, collection of the certificate and cooperation with inspections. Exclusive commercial rights should not be bundled into the same instrument. Commercial arrangements belong in the distribution agreement, and the two categories of right should be managed separately, because they have different durations, different remedies and different counterparties within the same company.

Insight 2: the validity period is both a legal requirement and an exit mechanism. Article 42 requires the period to be stated. For the manufacturer, a shorter grant coupled with an extension clause is more advantageous than an open-ended arrangement described as long term or indefinite: it creates a natural point at which the relationship can be reassessed without the need to allege breach. An instrument with no end date removes that point, and with it the cheapest available form of leverage.

Insight 3: the plant list has to be broken down by function. Section 2.2.3 requires every plant where the product is produced, filled or packed to be listed, which corresponds to the requirement in section 2.3.1 that quality management certificates be issued per plant. Inconsistency between the lists is a frequent cause of verification failure, particularly where a contract manufacturer fills or packs a product that is produced elsewhere: the producer appears on the signature page, the filler does not, and the quality certificate set does not match either document.

Insight 4: transfer and termination clauses have to be drafted with the registration in mind. A termination clause that ends the commercial relationship without addressing the registration leaves the certificate in place under an entity that no longer represents the manufacturer, while a transfer clause that is not matched by a cooperation obligation cannot be executed. Both should reference section 3.2.1 and the distribution agreement, so that the three documents move together rather than in sequence.

4. Practical recommendations

1. Sign the power of attorney and the distribution agreement as separate instruments: the first limited to regulatory powers, the second governing commercial arrangements.
2. Set the grant for 1 to 3 years with an extension clause (practical estimate), preserving a scheduled point at which the relationship is reassessed.
3. Align the plant list with the quality management certificates and the section 2.2.3 information page, checking names and addresses word by word rather than by reference to a group structure.
4. Include transfer and termination clauses that reference the ownership position under section 3.2.1, and make them operate automatically on termination rather than on request.

5. Verification checklist

• □ The grantor and the grantee are expressly identified
• □ The scope of the grant is limited to regulatory filing matters
• □ A defined start and end date is stated
• □ The product rights holder and all functional plants are listed in full
• □ Transfer and termination clauses are included and linked to the distribution agreement

Regulatory information verified as of October 29, 2026.

GRZAN supports medical device manufacturers, importers and authorised representatives with registration in Bolivia, including the drafting and review of powers of attorney against section 2.2.3 of Resolución Ministerial N° 010 and Article 42 of Decreto Supremo N° 25235, the alignment of plant lists with quality management certificates, and the design of transfer and termination mechanisms that keep the registration recoverable. For assistance with a power of attorney or a distribution structure in Bolivia, contact the GRZAN regulatory team at info@grzanglobal.com.

GRZAN applies a writing standard of conclusions first, traceable sources and verifiable figures to its regulatory publications, and follows the practice of AGEMED and the authorities cited in this series as it develops. For a market access plan that aligns the power of attorney, the plant configuration and the commercial agreement for Bolivia, the team welcomes your enquiry.