Paraguay Medical Device Registration 2026: Regente Digital Signature and Document Integrity Rules

1. Key takeaways

1. Article 2 of the operating instructions: all files uploaded to the system must carry the digital signature of the technical responsible party (Regente); the signature must sit in a prominent position on the first page and must not cover any data of the document.
2. Article 2.1: where a scanned copy of an original is submitted, it must additionally be certified by the notary office, beyond the digital signature.
3. Article 4 requires the information declared on the platform to match the uploaded documents; Article 5 requires the files to be clear and legible; Article 3 requires spelling and data-entry errors to be avoided.
4. Article 31: DINAVISA may verify the authenticity of the documents at any time, and the applicant and the technical responsible party answer for the completeness and truthfulness of the information; tampering, falsehood or unlawfulness, once established, is pursued under Article 243 of the Penal Code of Paraguay.
5. The signature obligation covers every attachment in the dossier, from the application form to the last supporting certificate, and there is no category of file that can go unsigned or carry a partial signature.

2. Legal basis

The operating instructions define the mechanical and formal rules of every upload, while the resolution supplies the liability framework: Article 28 makes the content of Annexes I to IV sworn declarations, and Article 31 gives DINAVISA the standing verification power and names the Penal Code provision that backs it. The signature rules interact with the rest of the dossier: a file that carries a signature covering data, or a signature placed where the reviewer cannot find it, fails the same acceptance screening as a missing signature. Position and visibility are therefore part of the signature requirement itself, and both are checked visually on the first page of every file. The formal rules are cheap to satisfy; the liability they protect is not.

3. Expert insights

Insight one: the digital signature is an acceptance threshold, not a decorative formality. Article 2 uses the expression todos los documentos adjuntados, meaning all attached documents, so the obligation covers every attachment and not only the application form itself. A single file missing the signature causes the situation described in Article 1, in which the evaluation does not start until the defect is cured. On the full analysis route, where the statutory evaluation period is 120 business days, losing days at the start of the clock to a signature defect consumes schedule that cannot be recovered later in the process. The cure is also slow, because the corrected file must be re-signed, re-uploaded and re-checked, and the clock does not move until the replacement is accepted.

Insight two: the technical responsible party is a liability-bearing figure, not a nominal role. Article 31 directs responsibility simultaneously at the applicant and at the technical responsible party, and anchors it in Article 243 of the Penal Code. Article 28 adds that the content of Annexes I to IV has the character of a sworn declaration. Every document the Regente signs therefore carries personal legal consequences, which makes the selection of the individual, and the internal review mechanism that precedes any signature, matters that deserve the same seriousness as the technical dossier itself. A signature given without an internal review record is a personal risk accepted without evidence of diligence, which is why the review workflow should leave traces that match every signed file.

Insight three: the list of prohibited actions in the operating instructions deserves line-by-line attention. Article 10 expressly prohibits: deleting attachments that have already been evaluated; deleting or altering declared data on the platform that have not been objected to, where a change is genuinely needed it must be submitted through the clarification field with reasons and supporting evidence; and deleting platform files except where the reviewer expressly requests it. The three prohibitions share one principle: after submission, the file record is an evidence chain that must not be altered at will. The prohibitions also define the safe channel for corrections: the clarification field, with reasons and evidence, is the only route that changes the record without touching the evidence chain.

4. Practical recommendations

1. Maintain a signature checklist for every attachment, and confirm file by file that the signature sits on the first page and covers no data, refreshing the checklist whenever the file set changes.
2. Define the review workflow of the technical responsible party with traceable records, and complete the data consistency check before any signature is applied, recording the reviewer, the date and the version reviewed with each signature.
3. After submission, route every data change through the clarification field with reasons and supporting attachments, and never edit the declared data directly.
4. Do not replace originals with scanned copies; where a scan is unavoidable, obtain notarial certification first under Article 2.1, and keep the certified scan as the working copy.
5. Train everyone who prepares uploads on the signature rules, because the requirement is easy to satisfy in advance and expensive to cure after submission.
6. Article 28 completes the liability picture: the content of Annexes I to IV is sworn, so every signature is a declaration whose truthfulness can be tested for the whole validity of the certificate.

5. Verification checklist

• □ All attachments carry the digital signature of the technical responsible party
• □ Signature sits prominently on the first page and covers no data
• □ Scanned copies certified by the notary office
• □ Platform declaration matches the document content item by item
• □ Post-submission changes routed through the clarification field with reasons

Regulatory information verified as of October 29, 2026.

GRZAN provides registration and conformity support in Paraguay for medical device manufacturers, importers and authorized representatives, including signature workflow design and post-submission change handling. For assistance, contact info@grzanglobal.com.