Paraguay Medical Device Registration 2026: Power of Attorney Content, Registration and Validity Requirements

1. Key takeaways

1. Article 6 inc. b) requires that the power of attorney or the distribution and sales authorization letter must contain three items of information:
   • the name (razón social) and full address of the legal manufacturer (fabricante legal);
   • the name and full address of the importing company (the applicant);
   • an express authorization of that importing company to represent and/or distribute and sell the manufacturer’s products in Paraguay.
2. These three items are cumulative mandatory elements; a missing element leads to failure in the priority ranking or to non-acceptance of the document. There is no cure mechanism that allows a defective letter to be patched at a later stage of the assessment, so the document should be reviewed line by line before filing.
3. The authorization document must also be registered in the Registro Público de Poderes (Public Registry of Powers of Attorney), and where no validity period is stated it is counted as valid for 2 years from the date of issuance.
4. Where the manufacturer withdraws the representation, the registration holder must notify DINAVISA immediately upon becoming aware of the withdrawal. This notification duty attaches to the holder, not to the manufacturer, and it operates without any grace period.

2. Legal basis

Article 6 inc. b) governs the full life of the representation document in a single provision: what it must say, where it must be registered, how long it lasts by default, and what happens when the representation ends. Reading the provision as a whole is important, because compliance at the drafting stage does not automatically carry through to the registration and renewal stages.

For multi-market groups, the drafting effort should not be underestimated. A letter that satisfies the three mandatory elements must still reconcile with the corporate law of the country where the manufacturer is established, since the signatory must have capacity to issue the authorization. Coordinating notarization, consular or apostille legalization where applicable, and the registry step in Paraguay takes calendar time, and that time belongs inside the project plan, because a filing cannot be made with a document that is still in the legalization pipeline. Aligning the legal-entity names in the letter with the CLV, the quality system certificate, and the labeling prevents secondary objections that would otherwise consume response windows.

3. Expert insights

Insight one: the substance of the three elements is to fix the chain of responsibility in writing. The first element establishes who made the product, the second establishes who imports it, and the third establishes the scope of the authorization. DINAVISA uses these three items to anchor the manufacturer–importer–market chain of responsibility in a single document. If any one element is missing, the chain is broken and the authority cannot determine the responsible party, which is why the defect cannot be tolerated at filing. Companies should treat the address element with particular care, because a generic group address that does not identify the specific manufacturing site invites documentary objections.

Insight two: the wording of the express authorization clause determines the scope of the license. The provision speaks of authorization to representar y/o distribuir y comercializar — to represent and/or to distribute and sell. A document that only grants distribution rights without representation rights may be challenged where the holder needs to act in the name of the registration before the authority, for example when submitting changes, responding to requests, or filing the renewal. Drafters should mirror the regulatory wording rather than paraphrasing it, since any narrower formulation creates a gap between the document and the obligations attached to holding the registration.

Insight three: the withdrawal notification duty follows an immediate standard, with no grace period. The text of the provision uses the formula de forma inmediata a partir de la toma de conocimiento — immediately from the moment of becoming aware. No number of days is set. This means that once the commercial relationship between manufacturer and holder breaks down, the holder has an immediate statutory reporting obligation, and a manufacturer that hopes to exert pressure through a silent withdrawal of the authorization cannot achieve that result legally: the withdrawal triggers a mandatory report by the holder. Both parties should therefore plan the communication sequence for a termination scenario before it happens.

4. Practical recommendations

1. Draft the authorization document element by element against the three mandatory items; take addresses down to street-number level and keep them consistent with the CLV and the quality system certificate on file.
2. State both representation and distribution-and-sales in the scope clause, so there is no gap in authority when the holder must act toward the authority as the registered party.
3. Complete the registration in the Registro Público de Poderes as soon as possible after signing; an earlier registration normally enjoys the better position in the priority ranking (practical estimate: an inference drawn from the ranking rules).
4. Provide in the distribution agreement a notification workflow and deadline for withdrawal scenarios, aligned with the statutory duty to notify DINAVISA immediately, including who drafts the notice and who signs it.
5. Re-verify the three mandatory elements whenever the manufacturer’s corporate name, registered address, or signatory changes during the life of the certificate, and reissue the letter and its registry registration in step, so the document on file never drifts away from the current corporate reality of the issuing entity.

5. Verification checklist

• □ Authorization document states the manufacturer name and full address
• □ Document states the name and full address of the importing company
• □ Document contains the express authorization to represent and/or distribute and sell
• □ Registration in the Registro Público de Poderes completed
• □ Validity period expressly stated or managed under the 2-year rule

Regulatory information verified as of October 29, 2026.

GRZAN provides medical device registration support in Paraguay for manufacturers, importers, and authorized representatives, covering authorization letter drafting, registry registration, and notification workflows. Contact info@grzanglobal.com for tailored guidance on this topic.