Paraguay Medical Device Regulation 2026: DINAVISA as National Regulatory Authority

1. Key takeaways

1. The competent authority for medical devices in Paraguay is the Dirección Nacional de Vigilancia Sanitaria (DINAVISA), the National Directorate of Health Surveillance. It sits administratively within the Ministry of Public Health and Social Welfare (MSPBS) system, yet under Ley N° 6788/2021 it enjoys administrative autonomy, financial self-sufficiency and ownership of its own assets, and it may issue technical regulations on its own initiative (Article 5, inc. b) of Ley N° 6788/2021).
2. The dedicated legal authority for device sanitary registration is Article 4, inc. b) of Ley N° 4659/12. The current master regulation in force is Resolución DINAVISA N° 226/2024, which entered into force on September 16, 2024 by virtue of its Article 36.
3. All registration, post-marketing change and renewal applications are submitted electronically through the DINAVISAPy platform. Paper dossiers pending at the time of entry into force were migrated within 30 business days as required by Article 32.
4. Devices are classified into four risk classes (Clase I-IV). Class I follows a mandatory sanitary notification route (NSO), while Classes II to IV obtain a sanitary registration certificate. Both instruments remain valid for 10 years (Article 10).

2. Legal basis

3. Expert insights

Insight 1: organizational law and product law are separate, which means the question of who regulates and the question of on what legal basis are two distinct matters. Ley N° 6788/2021 addresses whether DINAVISA has the power to set rules; Article 4, inc. b) of Ley N° 4659/12 provides the superior authorization for the device registration system itself. When companies cite legal grounds in disputes or communications with the authority, the two levels cannot substitute for each other. A challenge to the legality of a procedure must be anchored in the organizational law, while a challenge to product requirements must be anchored in the product law and the current resolution. Files that mix these two levels tend to lose precision at exactly the moment the argument matters most, and authorities respond poorly to citations that do not match the layer of the question being asked.

Insight 2: autonomous status translates directly into the power to set its own fees. Precisely because DINAVISA is financially self-sufficient, Article 35 of Resolución N° 226/2024 delegates fee-setting power to its General Administrative and Financial Directorate, with amounts graded by device category. This means that fee amounts do not appear in the body of the resolution. Any quotation given to a client must rely on the official fee schedule in force at the time, and figures taken from secondary sources cannot be used as a basis for budgeting or contracts. The fee categories follow the device class and the type of application, so initial registration, change and renewal are priced as separate lines rather than as one combined amount.

Insight 3: full electronification is an irreversible compliance baseline. Article 32 granted a 30 business day migration window, after which unmigrated files were deemed rejected and archived by operation of law (de pleno derecho). Beyond the deadline itself, the deeper lesson is that DINAVISA shows very low tolerance for procedural form: formal defects convert directly into substantive consequences. Teams that treat submission format as an administrative afterthought assume a risk that is entirely avoidable through disciplined use of the DINAVISAPy platform. The platform is not a convenience channel but the procedural venue itself, and a submission that does not exist in it has no procedural existence at all.

4. Practical recommendations

1. Maintain a Paraguay regulatory ledger structured across five layers: organizational law, product law, current resolution, operating instructions, and annual listings, and compare it against the Dispositivos Médicos y Odontológicos – DM section of the DINAVISA website every quarter, recording the date of each check so that currency of the file can be demonstrated on demand.
2. Replace regulatory citations in all client dossiers, SOPs and distribution agreements with Resolución N° 226/2024 and the specific article numbers, and remove every remaining reference to Resolution 669/2016, so that every citation in circulation points to one single current source and version conflicts cannot arise between departments.
3. At project launch, lock down three items simultaneously: the appointment of the technical responsible person (Regente), the category of the business operating permit (Habilitación), and the registration status of the power of attorney. These three items determine whether an application is admitted at all, before the completeness of the dossier is even examined, so no drafting effort should be spent on a file that cannot be admitted.
4. In commercial quotations, state only that official fees will be settled according to the DINAVISA fee schedule in force at the time, without fixing any amount, and revisit the pricing position whenever the authority updates its published fee schedule.

5. Verification checklist

• □ Confirmed that the current master regulation is Resolución DINAVISA N° 226/2024 (effective September 16, 2024 under Article 36)
• □ Downloaded and archived the official PDF and the operating instructions Instructivo ITR–DGRS-002, Version 02
• □ Confirmed that the device category follows the four-class system (Clase I-IV)
• □ Verified the corporate entity status on the DINAVISAPy platform
• □ Confirmed that fees follow the official fee schedule in force (practical estimate: amounts are not published in the body of the resolution)
• □ Removed remaining references to Resolution 669/2016 as a current instrument from website content

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.