Paraguay Medical Device Registration 2026: Withdrawal Notice Obligations and Type I Change Procedures

1. Key takeaways

1. Final paragraph of Article 6 inc. b): where the manufacturer withdraws the representation authorization of the registration holder, the license-holding company must notify DINAVISA immediately upon becoming aware (de forma inmediata). The duty is triggered by knowledge, not by receipt of a formal document, and it runs in favor of the authority.
2. Article 13 change table classifies changes of the registration holder / manufacturer / distributor / commercial name (Cambio de Razón Social) as a Type I change: it may be implemented immediately once notified. No prior approval is required for this category.
3. The documentation for Type I changes follows two lines: for domestic products, a change certificate issued by DINAVISA is submitted; for imported products, a letter or sworn declaration issued by the importing company, together with a document issued by the competent authority of the country of origin or by the manufacturer stating the updated data.
4. Where the change affects the label, the application must additionally, under Article 14 of the Instructivo, submit the current label draft and the updated draft with the modifications marked. A label change without the comparative marking is treated as incomplete.

2. Legal basis

The withdrawal duty and the change table belong to the same practical scenario: a termination or restructuring of the representation relationship. The resolution sets the duties and the classification, while the Instructivo sets the documentary mechanics for each change category.

Sequence planning matters because the two regimes operate on different clocks. The withdrawal notification under Article 6 inc. b) is immediate, while the change filings under Article 13 and the Instructivo are document-driven and can be prepared in advance. A termination scenario therefore typically produces two parallel workstreams: the immediate report of the withdrawn representation, and the subsequent formalization of whatever follows — a new authorization letter for a successor applicant, a change filing, or a fresh application. Companies that pre-draft the notification templates and the evidence packages during the life of the agreement, rather than after it breaks down, shorten the exposed period during which the certificate exists but its representation basis has already ended.

3. Expert insights

Insight one: the immediate notification duty is a statutory obligation of the license-holding company and does not require the manufacturer’s consent. The provision designates the registration holder (Titular del producto) as the obligated party. This means the holder cannot delay reporting even if the manufacturer prefers to handle the matter quietly; conversely, a manufacturer that fears the holder will sit on the report should bind the notification duty to contractual liability in the agreement. The two parties should align on who communicates what to the authority, because a duplicated or contradictory notice creates avoidable questions in the file.

Insight two: a change of entity name goes through the Type I channel, but changing the entity is not the same as renaming it. The Article 13 change table supports changes of the name (Razón Social) or address, which are implemented immediately as Type I. Substituting one legal entity for another (for example, replacing importer A with importer B) is legally different and cannot follow the name-change route; it must be assessed anew against the holder-determination rules of Article 6 inc. b) (practical estimate: a judgment based on the structure of the provisions). Companies planning restructurings should classify the operation correctly before choosing the filing pathway.

Insight three: an address change pulls the BPAyD into the picture. Under the change table, a domestic product changing its address must submit a BPAyD certificate issued by DINAVISA stating the new address. As soon as the address changes, the storage and distribution qualification must be re-confirmed — a connected action that is frequently overlooked, with the result that the change filing stalls pending a new practices certificate. Plan the BPAyD update in parallel with the address change, not after it.

Insight four: the Type I evidence split reflects where the authority can verify by itself. For domestic products, DINAVISA issues the change certificate directly and can confirm the change against its own records; for imported products, the authority cannot consult the commercial register of another country, so it substitutes a declaration from the importing company plus evidence from the country of origin or the manufacturer. Understanding this design helps applicants predict what will be asked in any change filing: wherever DINAVISA cannot self-verify, expect a document from the party closest to the fact. Preparing those documents at the source — with the manufacturer or the origin-country authority — is the reliable way to keep change timelines short.

4. Practical recommendations

1. State clearly in the distribution agreement that on withdrawal of the authorization by the manufacturer, the license-holding company must complete the notification to DINAVISA within an agreed deadline, with defined consequences of breach.
2. Before any change of entity name or address, confirm it falls within Type I and prepare the corresponding evidence: the DINAVISA certificate for the domestic line, or the country-of-origin or manufacturer document for the imported line.
3. On an address change, verify in the same step that the BPAyD certificate address is consistent.
4. For every change touching the label, submit the current draft plus the updated draft with the modifications marked, following the Instructivo Article 14 pattern.

5. Verification checklist

• □ Agreement sets out the notification duty and consequences on withdrawal of the authorization
• □ Change classified as name/address change (Type I) or as change of entity
• □ Imported line has obtained the updated-data document from the country of origin or the manufacturer
• □ Address change verified against the BPAyD certificate in the same step
• □ Label changes submitted as current draft and updated draft with markings

Regulatory information verified as of October 29, 2026.

GRZAN provides medical device registration support in Paraguay for manufacturers, importers, and authorized representatives, covering withdrawal scenarios, change filings, and label documentation. Contact info@grzanglobal.com for tailored guidance on this topic.