Paraguay Medical Device Registration 2026: License Holder Priority and Representation Rules

1. Key takeaways

1. Article 6 inc. b) provides that the registration dossier must include a power of attorney or a distribution and sales authorization letter issued by the manufacturer, and the application is submitted by the importing company (the applicant) in Paraguay. This means the license holder is the Paraguayan importing enterprise that files the application, not the foreign manufacturer. Unlike markets where the manufacturer can hold the registration itself and simply appoint distributors, the Paraguayan model places the sanitary registration in the name of a local economic actor from the outset.
2. When two or more companies claim representation of the same manufacturer for the same product, the regulation resolves the conflict through a fixed priority order:
   • First priority: the company holding an exclusive representation letter (carta de representación exclusiva) issued by the manufacturer;
   • Second priority: where no exclusivity clause exists, the company holding an authorization letter issued directly by the manufacturer; a letter issued by a distributor is expressly excluded from the ranking.
3. The ranking rule applies simultaneously at the registration stage and at the renewal stage — Article 12 inc. h) again requires the power of attorney or distribution authorization letter in the renewal dossier. A document that was sufficient at first registration can therefore become defective ten years later if the manufacturer has issued a competing exclusive letter in the interim.
4. What determines the license holder is not the investor behind the application or the party that pays for the process, but the content of the authorization letter and the entity that issued it. Companies planning a Paraguay market entry should therefore treat the authorization letter as the controlling legal document of the entire project, not as a routine annex.

2. Legal basis

Resolución DINAVISA N° 226/2024 is issued by the Dirección Nacional de Vigilancia Sanitaria (DINAVISA) under the Ministry of Public Health and Social Welfare and governs sanitary registration and NSO (Notification Sanitaria Obligatoria) filings for medical devices. The priority-order mechanism in Article 6 inc. b) is the operative rule for determining which of several competing applicants obtains the registration when the same manufacturer product is concerned.

The practical consequence of this design deserves emphasis. Because the certificate follows the applicant rather than the product, commercial events on the manufacturer side — a change of regional distributor, a dispute with the local partner, or a group restructuring — have no automatic effect on who holds the registration in Paraguay. The license moves only through the mechanisms the resolution itself provides: the priority ranking at filing, the change procedures at renewal, or a fresh application. Companies should therefore map the holder question at the start of the project, when the authorization letter is still being drafted, because it becomes progressively harder to change once the certificate has been issued.

3. Expert insights

Insight one: the Paraguayan holder rule is a strong one-license-one-entity structure. Unlike markets that allow the same product to be held by several importers in parallel, the ranking rule in Article 6 inc. b) means that the same product of the same manufacturer will normally be registered to a single company. This operates both as channel protection and as channel lock-in: once the manufacturer signs an exclusive letter, it has handed over access control for the entire Paraguayan market for as long as the letter and the registration remain in force. Any second importer that later wishes to enter must either obtain a new authorization structure from the manufacturer or wait for the existing registration relationship to end.

Insight two: a letter issued by a distributor is excluded, and this is a trap that is easy to step into. Group-structured companies frequently have a regional distributor or a trading platform issue authorization letters on behalf of the group. In Paraguay, such letters are eliminated at the first step of the ranking. To preserve eligibility for holding the license, the authorization letter must be issued directly by the manufacturer (fabricante). Corporate groups should audit their template documents early, because a letter that is valid elsewhere in the region may simply fail the Paraguayan test.

Insight three: the ranking rule combined with the validity rule creates a window-period risk. Where the authorization letter does not state a validity period, it is counted as valid for 2 years from issuance under Article 6 inc. b). If an exclusive letter lapses without renewal and another company holding a valid letter files in that window, the ranking outcome can flip. Management of the validity period of the authorization letter is therefore not a formality but a substantive safeguard of the right to hold the license, and it deserves calendar-level monitoring in the same way as the registration renewal itself.

4. Practical recommendations

1. Have every authorization letter issued directly by the manufacturer; never route it through a distributor, trading platform, or group headquarters. Verify the signatory holds authority to bind the manufacturing entity.
2. Complete a strategic assessment before granting exclusivity: what exclusivity typically buys is channel investment and commitment from the local partner, and the price is control of the market for the 10-year validity period of the certificate, with renewal implications beyond that.
3. State the validity period of the authorization letter expressly in the document, so the 2-year default rule does not apply and force frequent reissuance. Align the stated period with the expected certificate issuance date plus a buffer.
4. Where the license is held by a local entity independent of the distributor, include in the distribution agreement a clause on cooperation with transfer of the registration on demand, with defined trigger events, deadlines, and cost allocation.

5. Verification checklist

• □ Authorization letter issued directly by the manufacturer
• □ Strategic cost of exclusivity clauses assessed before signing
• □ Validity period of the letter expressly stated or managed under the 2-year rule
• □ Renewal dossier includes the document required by Article 12 inc. h)
• □ Distribution agreement contains a transfer-cooperation clause

Regulatory information verified as of October 29, 2026.

GRZAN provides medical device registration support in Paraguay for manufacturers, importers, and authorized representatives, covering holder structuring, authorization letter drafting and ranking risk assessment, dossier preparation, and life-cycle maintenance. Contact info@grzanglobal.com for tailored guidance on this topic.