Paraguay Medical Device Registration 2026: National vs Imported Product Documentation Requirements

1. Key takeaways

1. Article 6 sets out the documentation in two paragraphs: six items (a to f) for national products (PRODUCTO NACIONAL) and eight items (a to h) for imported products (PRODUCTO IMPORTADO).
2. The six national items are: a) a BPF/GMP certificate issued by DINAVISA or an equivalent certificate such as ISO 13485; b) an outsourcing contract whose signatures must be certified by a notary office; c) a finished product quality control certificate; d) a stability study; e) the label and instructions for use; f) the ARRN license for radiation-emitting devices.
3. First difference: the issuing authority for the quality system evidence is different. National products require a BPF/GMP certificate issued by DINAVISA itself, while imported products may rely on certificates issued by the competent authority of the country of origin or by international certification bodies.
4. Second difference: the free sale certificate (CLV) under item d) and the agency power of attorney under item b) exist only on the import side. A national product has neither a foreign marketing question to prove nor a cross-border agency arrangement to document.

2. Legal basis

Both instruments were prepared for the DINAVISAPy filing environment. The resolution defines what must be submitted for each origin category, and the operating instructions add establishment-level obligations, notably the good storage and distribution practices (BPAyD) certificate required of national establishments for their storage and distribution activities. The two lists are not interchangeable in either direction: the same device can move between the categories only by rebuilding the dossier under the correct heading, because the items, the issuing bodies and the preliminary establishment work differ. Knowing why each additional item exists on the import side therefore shortens the preparation work on both routes.

3. Expert insights

Insight one: the essential difference is whether the regulator can see the operation directly. For a national product, the manufacturing site sits inside Paraguay, so DINAVISA can confirm production quality directly through a BPF/GMP certificate it issues itself; no free sale certificate is needed to prove indirectly that the product is lawfully marketed. For an imported product, the manufacturing activity happens abroad, and the regulator can only rely on indirect evidence: the CLV, which proves the product is lawfully marketed in its country of origin, and the quality system certificate, which proves the production process is compliant. The documentation lists are therefore not arbitrary; each extra item on the import side substitutes for a form of oversight that DINAVISA cannot exercise directly outside its territory. In practice, the review of an import dossier begins with the two questions a national dossier never asks: whether the product is lawfully marketed where it was made, and who lawfully represents the manufacturer in Paraguay. The two extra items on the import list answer exactly those questions.

Insight two: the barrier on the national route is the establishment, while the barrier on the import route is the document chain. A national applicant must hold a certificate of good manufacturing and control practices issued by DINAVISA, and the storage and distribution activities must additionally be supported by a good storage and distribution practices (BPAyD) certificate, as stated on page 3 of the operating instructions. This is a build-first, file-later route: facilities, personnel and quality systems must be in place before any dossier is submitted, so the upfront investment is far higher than on the import route, where the applicant assembles existing foreign documents instead. Applicants who budget for establishment certification from the outset avoid the most common failure of the national route, which is committing to a filing date before the facility work is finished.

Insight three: changing the place of manufacture switches the entire documentation logic. If the same product starts to be manufactured in a local Paraguayan facility, the list shrinks from eight items to six, but the applicant takes on the establishment certification obligations that come with it; if production moves back offshore, the CLV and the agency power of attorney must be added again. Companies with multi-site manufacturing strategies therefore need to maintain a separate dossier concept for each origin scenario, because the evidentiary structure, the responsible parties and the lead times all change with the route. The transitions are rare but expensive when improvised; companies that anticipate them keep template dossier structures for each origin scenario ready before the strategic decision is taken.

4. Practical recommendations

1. Fix the origin attribute of the product before starting dossier preparation, so that work is never built against the wrong item list.
2. On the national route, plan the establishment preparation period for BPF/GMP and BPAyD certification into the overall project calendar before committing to any filing date, keeping the certification calendar, the inspection dates and the intended filing date on a single timeline.
3. On the import route, manage the validity of the CLV and the power of attorney actively; where no validity period is stated, both are deemed valid for 2 years from issuance.
4. Remember that the outsourcing contract for national products must carry notarially certified signatures; the formal requirement resembles the import side, but the certification chain that produces it is different, which is why the notarization step should be booked before the contract is signed.

5. Verification checklist

• □ Origin attribute confirmed (national / imported)
• □ National route: BPF/GMP and BPAyD establishment preparation planned
• □ Import route: CLV and agency power of attorney obtained
• □ Outsourcing contract certified according to the applicable route
• □ Separate dossier files maintained for each multi-site scenario

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 both national and import routes from establishment planning to DINAVISAPy submission. For assistance, contact info@grzanglobal.com.