Paraguay Medical Device Registration 2026: Device Definition and Product Scope

1. Key takeaways

1. The official definition of a device on the DINAVISA website covers instruments, apparatus, hospital consumables and other items, including their packaging as well as the raw materials, components, parts, pieces or accessories that constitute them, intended for use individually or in combination on the human body. The definition is deliberately functional: it looks at what the item does and where it is applied, not at how the manufacturer labels its commercial category.
2. The list of intended purposes includes the diagnosis, prevention, monitoring, treatment and relief of disease, and equivalent management of injury or disability; it extends further to investigation, replacement or modification of anatomy, regulation of physiological processes, and contraception, so several families of products that are treated as consumer goods elsewhere fall inside the definition here.
3. The definitions chapter of the current resolution (items 16 to 24) adds precision: procedure sets (kits/sets) are collections of devices that could be registered individually but are combined into a single sales unit to serve a specific purpose or a specific operation (item 20), and sharps are medical devices whenever they can pierce the skin in use, regardless of size and depth (item 22). Item 23 defines the NSO, which is the instrument through which Class I products are cleared.
4. The direct consequence of the breadth of the definition is that categories managed elsewhere as consumables, accessories or fittings must first pass the device determination in Paraguay, and only then proceed to classification and to the choice of route; reversing that order is the most expensive sequencing error in the market entry plan.

2. Legal basis

3. Expert insights

Insight 1: because the definition expressly includes packaging and raw materials, the supply chain upstream is pulled into regulatory view. The instinct of many companies is to register only the finished product, but the definition explicitly covers the raw materials, components, parts and accessories that constitute the device. This affects two things directly: the level of detail required in the materials and composition sections of the technical dossier, since the operating instructions require a declaration of chemical composition, the composition of each model and the main parts, and the contractual disclosure duty for outsourced production stages, since Article 6, inc. c) requires outsourcing contracts to be submitted with the application. Suppliers of raw materials should be told early that their specification documents will be needed, since procurement lead time, not drafting, is usually the bottleneck.

Insight 2: the definition covers research use and contraception, so the boundary is wider than expected. Research-purpose products and reproductive health products that are commonly handled as non-medical items in other markets risk being stopped at the determination stage in Paraguay if they are filed under a non-medical rationale. The correct sequence of judgment is: definition first, then classification, then route. Skipping the first step means that everything built afterwards has to be redone, and the cost of that rework is usually far higher than the cost of a documented determination made at the start. A written determination also protects the company if the same SKU is later questioned by a distributor or customs broker.

Insight 3: the definition of kits/sets directly determines the submission unit. Item 20 defines a kit or set as a collection of devices that could be registered individually but are combined into a single sales unit, and Article 21 further provides that the procedure is set by the highest risk class within the collection. A set containing Class II and Class III components therefore proceeds as a Class III product as a whole, rather than being split so that the lowest-risk component governs. Submission architecture should be designed around this rule from the beginning, because splitting or merging sets after a file has been filed is not a formal variation but a different application. Where a set mixes classes, the technical justification should address every component, not only the governing one, since reviewers read the set as one product.

4. Practical recommendations

1. Build a device determination table and answer it for every SKU: whether the item is applied to the human body, whether it falls within the list of intended purposes, and whether it is an accessory or a component; archive the completed table as the entry record of the project.
2. Bring the materials and composition declarations in the technical dossier down to model level as the operating instructions require, and attach supporting documents issued by the manufacturer, so the level of detail matches what the definition of the device implicitly demands.
3. For set products, set the route by the highest-risk component, and calculate quotations and timelines on the basis of that class rather than the average of the set, since the filing fee, review depth and timetable all follow the governing class.
4. Where production is outsourced, prepare the outsourcing contract signed by both parties and authenticated by a notary office well before the submission date, since it is a required dossier item under Article 6, inc. c) and cannot be produced quickly once a reviewer asks for it.

5. Verification checklist

• □ Device determination completed for all SKUs (including accessories, components and packaging)
• □ Route for set products determined by the highest risk class
• □ Materials and composition declarations in the technical dossier brought to model level
• □ Outsourcing contracts prepared with signatures authenticated by a notary office
• □ Determination conclusions archived and traceable

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.