Paraguay Medical Device Regulation 2026: Resolución 226/2024 Scope and Annex System

1. Key takeaways

1. Resolución DINAVISA N° 226/2024 was signed in Asunción on August 27, 2024, and Article 36 provides that it enters into force on September 16, 2024. It is the only master regulation currently in force for medical devices, and every procedural question in the Paraguay file should be answered from its text first.
2. The body of the resolution comprises 27 pages and 37 articles, supported by Annex I (classification rules), Annex II (Class I sworn declaration), Annex III (change declaration), Annex IV (renewal declaration) and Annex V (implant card, Tarjeta de Implantación). The annexes are not optional reading: three of them are declaration forms whose content binds the applicant as a sworn statement.
3. The scope of application (Article 5) covers registration applications, post-marketing changes and renewals for domestically manufactured and imported devices, together with the application, post-issuance changes and renewals of the NSO, so no lifecycle stage of either instrument falls outside the resolution.
4. The companion operating instructions are Instructivo ITR–DGRS-002, Version 02, effective September 9, 2024, comprising 14 pages, issued by the Dirección de Registro de Dispositivos Médicos y Odontológicos (Directorate for the Registration of Medical and Dental Devices); they translate the resolution into field-level filing instructions used in the DINAVISAPy platform.

2. Legal basis

3. Expert insights

Insight 1: the effective date of the resolution and the effective date of the operating instructions differ, so scheduling must not confuse them. The operating instructions carry an effective date of September 9, 2024, while the resolution entered into force on September 16, 2024. The two dates are seven days apart, but the legal anchor is Article 36 of the resolution. Any judgment about whether pending applications are governed by the old or the new regime must use September 16, 2024 as the dividing line, and internal templates should record both dates to prevent misapplication during audits or file reviews. Where an application straddles the two dates, the safest course is to confirm the treatment with the authority in writing and record the answer in the project file. Schedules that borrow the instruction date for legal milestones create a week of false certainty that audits do not forgive. Template owners should encode the September 16, 2024 date once, in the template, and remove manual date entry from the workflow.

Insight 2: Article 5 lists post-issuance changes for the NSO separately, which shows that Class I is not exempt from oversight. The resolution uses the term modificación post autorización for the sanitary registration certificate and modificación post emisión for the NSO. The difference in wording reflects the nature of the NSO as a sworn declaration instrument: its change logic differs from that of an approval-based certificate, but changes still must be declared and fees still apply. Teams that treat notification products as maintenance-free accumulate silent non-conformities that surface at renewal, when correcting them is both slower and more expensive than declaring them in time. The ledger should record declaration dates, not just filing dates, because the change obligation attaches to the event, not the paperwork.

Insight 3: the annex system makes responsibility explicit. Article 28 provides that the contents of Annexes I to IV have the character of a sworn declaration (declaración jurada), and all information is the responsibility of the applicant; once falsehood, forgery or tampering is established, civil, criminal and administrative liability is triggered. Annex V is the implant card, which places the traceability obligation for implantable devices on the hospital side, where patient identification, the implanting institution, the implant date and the operating physician must be recorded. Hospitals unfamiliar with the obligation should be briefed at contract stage, since the card travels with the device, not with the registration file. The declaration forms should be filled from controlled source data, never from memory or from a previous application, because a copied error inherits the liability of the original.

4. Practical recommendations

1. Build the internal regulatory library as a set of seven documents: the resolution body, the five annexes and the operating instructions; none may be missing, and Annex V is activated only for implantable device projects, where the implant card workflow must be agreed with the importing hospital in advance.
2. In project plans, fill the applicable regulation version field uniformly with September 16, 2024 and thereafter, avoiding any mixing with the September 9, 2024 date of the operating instructions, so that legal milestones and operational milestones never borrow each other’s dates.
3. Bring Class I products into the same change and renewal ledger as registered products, and reject the assumption that notification equals no maintenance; annual reviews should cover NSO files as well, including confirmation that the declared class still matches the product as placed on the market.
4. For implantable projects, prepare the implant card template in advance, containing patient identification, the implanting healthcare institution, the implant date, and the signature and professional registration number of the operating physician, and confirm with the hospital who completes and stores the card after each procedure.

5. Verification checklist

• □ Obtained the 27-page resolution body and Annexes I to V
• □ Obtained the operating instructions Instructivo ITR–DGRS-002, Version 02 (September 9, 2024)
• □ Applicable regulation version field standardized to September 16, 2024
• □ Dividing date of September 16, 2024 confirmed for pending applications
• □ Change and renewal ledger established for Class I products
• □ Annex V implant card template prepared for implantable projects

Regulatory information verified as of October 29, 2026.

GRZAN provides medical device registration support in Paraguay for manufacturers, importers and authorized representatives. For inquiries, contact info@grzanglobal.com.