Paraguay Medical Device Registration 2026: Article 6 Import Product Dossier Requirements (Items a to h)

1. Key takeaways

1. Article 6, second paragraph, under the heading PRODUCTO IMPORTADO lists exactly eight documentary items, lettered a) through h), for registering imported medical devices. The applicant declares the technical information for each item on the DINAVISAPy platform and uploads the corresponding files.
2. The eight items are: a) a BPF/GMP certificate or an equivalent attestation such as ISO 13485, CE, UL, FDA, TÜV or MDSAP; b) a power of attorney or a distribution and sales authorization letter registered in the public registry of authorizations; c) an outsourcing contract; d) a free sale certificate or an equivalent document; e) a finished product quality control certificate or a notified body conformity certificate; f) a stability study; g) the Spanish-language label and instructions for use; h) the radioprotection license for devices that emit radiation.
3. Where items b) and d) do not state a validity period, they are deemed valid for 2 years from the date of issuance.
4. Every document must remain valid at the moment the certificate or the NSO is issued, so applicants must plan renewals backwards from the expected issuance date across the statutory evaluation timeline.

2. Legal basis

The resolution issued by DINAVISA, the Dirección Nacional de Vigilancia Sanitaria, entered into force through its Article 36 on 2024-09-16 and applies to all market authorization filings processed through the DINAVISAPy platform. The operating instructions complement the resolution by defining how the platform fields must be completed and in what state each uploaded document must be at the moment of issuance. The eight items operate as one package: under Article 1 of the operating instructions the evaluation does not start until the file is complete, so a single missing or expired item suspends the entire application rather than one field. The items should therefore be collected in parallel, with the validity of each tracked against the same expected issuance date.

3. Expert insights

Insight one: the eight items cover four lines of evidence: who made it, who is responsible, the product itself, and how it is presented. Item a) evidences the production quality system behind the device; items b) and c) define the responsible party in Paraguay and the boundaries of the manufacturing arrangement; items d), e) and f) evidence the origin, quality and stability of the finished product; item g) governs the presentation of the product on the market; and item h) is an additional license for a special product category. Preparing the dossier along these four lines, with each line owned by a specific function, is a more reliable method than ticking the list item by item, because it exposes gaps that a mechanical checklist review tends to miss. The four lines also divide the work naturally between quality assurance, legal, regulatory and labelling functions, which is why dossiers prepared this way move through review with fewer internal handover errors.

Insight two: the 2-year default validity rule turns document validity management into a scheduling variable. The power of attorney under item b) and the free sale certificate under item d) are deemed valid for 2 years from issuance when no validity period is stated. The statutory evaluation period for the full analysis route is 120 business days, and once rectification rounds are added, each of which runs 60 + 30 business days, the actual span from submission to issuance can approach or even exceed 2 years (practical estimate: derived from the structure of the provisions). This means that a document that is valid at submission will not necessarily survive until the certificate is issued. Since Article 8 of the operating instructions requires every document to be valid at the moment of issuance, renewal points must be planned against the worst-case timeline rather than the optimistic one. The same countdown logic applies to every other item with a stated validity, so one table can govern the validity of the whole dossier.

Insight three: item e) offers a choice between two routes, but the evidentiary strength of the two routes is different. The finished product quality control certificate must include all of the tests that ensure the functionality, quality and safety of the product, executed against current standards; the notified body conformity certificate, by contrast, is a systematized third-party conclusion over the product and its conformity assessment. Manufacturers that already hold CE certificates generally find the notified body route simpler to assemble, because the underlying assessment already exists, but they must confirm that the scope of the certificate covers every model declared in the application, since a model gap will surface during review. Verifying the scope before filing is a minutes-long check that prevents a model gap from surfacing mid-review, where correction is slowest.

4. Practical recommendations

1. Build a document matrix along the four evidence lines described above, and assign each line a responsible owner and a completion deadline that feed into the master submission schedule.
2. Maintain a validity countdown table for items b) and d): measure the remaining validity against the expected issuance date, and renew any document whose remaining margin falls short of 2 years before filing.
3. For item e), prefer a notified body certificate whose scope covers all declared models in a single document, avoiding partial coverage that would force supplementary submissions during review.
4. For devices that emit radiation, including certain imaging and treatment equipment, start the license procedure with the radiation and nuclear regulatory authority (ARRN) early, because this item is typically on the critical path of the whole application.

5. Verification checklist

• □ Item a): BPF/GMP or ISO 13485/CE/UL/FDA/TÜV/MDSAP certificate obtained and valid
• □ Item b): power of attorney registered in the public registry of authorizations, validity counted backwards
• □ Item c): outsourcing contract prepared, with notarially certified signatures
• □ Item d): CLV obtained and covering all declared models, validity counted backwards
• □ Item e): QC certificate or notified body certificate covering all models
• □ Item f): stability study prepared as applicable to the product
• □ Item g): label and instructions for use fully translated into Spanish
• □ Item h): ARRN license obtained for radiation-emitting devices

Regulatory information verified as of October 29, 2026.

GRZAN provides registration and conformity support in Paraguay for medical device manufacturers, importers and authorized representatives, covering dossier assembly, DINAVISAPy submission and lifecycle document maintenance. For assistance, contact info@grzanglobal.com.