Paraguay Medical Device Regulation: International Regulatory Cooperation (IMDRF, WHO and ANVISA)

1. Key takeaways

1. In October 2024, DINAVISA became an affiliate member of the International Medical Device Regulators Forum (IMDRF) (according to public industry reports; the exact membership category is pending verification against the official IMDRF membership list).
2. On April 28, 2026, DINAVISA took office as vice-chair of the member mechanism of the World Health Organization (WHO) guiding committee on substandard and falsified medical devices (DINAVISA website news of 2026-04-28).
3. On August 20, 2026, DINAVISA and the Brazilian ANVISA signed a new memorandum of understanding on cooperation, replacing the memorandum of March 2024, with a validity of 5 years, covering medical devices among its product categories.
4. The memorandum covers: sharing of laboratory data, coordination of inspections, exchange of premarket assessment and registration information, exchange of post-market surveillance information, and joint actions against counterfeiting and illegal circulation.

For sponsors, the sequence of these milestones matters as much as the milestones themselves: the IMDRF seat builds methodological alignment, the WHO office builds enforcement credibility, and the memorandum builds a concrete bilateral channel, so each step makes the next one easier to argue in a filing.

2. Legal basis

The cooperation items and the domestic procedure meet inside Article 8, inc. a) of Resolution 226/2024, which conditions the simplified registration route on recognition by a regulatory authority that has concluded a bilateral recognition agreement with Paraguay and whose agreement is published on the DINAVISA website. International cooperation is therefore not a diplomatic sideline: each step, from the IMDRF seat to the renewed ANVISA memorandum, feeds the evidence base that a sponsor can later argue when claiming the simplified procedure.

Three external developments and one domestic provision form the frame of this chapter. The IMDRF membership connects DINAVISA to the global harmonization agenda; the WHO office embeds it in the fight against substandard and falsified devices; the ANVISA memorandum builds a bilateral bridge with the largest regulator in the region; and Article 8, inc. a) of Resolution 226/2024 is the domestic gate through which these relationships become procedural advantages for sponsors. The variety of the MoU scope, reaching beyond devices into medicines, biological products, cosmetics, food and tobacco, suggests the relationship is designed to be durable rather than single-issue. Any one of the three external items would be notable; their accumulation inside two years marks a deliberate strategy.

3. Expert insights

Insight one: international coordination connects regulatory trust at one end and the simplified pathway at the other. Article 8, inc. a) lists authorities that have signed bilateral recognition agreements with Paraguay, published on the DINAVISA website, as eligible for the simplified registration procedure. The ANVISA–DINAVISA memorandum expressly includes the exchange of premarket assessment and registration information, which strengthens the arguability of the simplified route for products already approved in Brazil. For sponsors holding ANVISA decisions, the memorandum converts a general statement of friendship between agencies into a document that can be cited in a filing strategy.

Insight two: the WHO office connects directly with border enforcement. According to Brazilian Federal Police data for 2026, the volume of weight-loss medicines seized at the border reached 165,589 units by June 2026, more than double the figure for the whole of 2025 (60,865 units). This is the real-world backdrop against which both agencies deepened their cooperation. For legally certified companies, stricter enforcement means that the market space available to products without certificates shrinks, and the relative value of holding a regular registration rises. Enforcement intensity is thus a market-structure variable, not only a security headline.

Insight three: IMDRF membership signals the long-term direction of regulatory convergence. Joining the IMDRF as an affiliate member typically means the authority will align its classification, post-market surveillance and system audit practices with internationally accepted approaches. This matches the goal DINAVISA has publicly expressed of becoming a reference authority (ARN). Convergence cuts both ways: requirements will become stricter over time, but at the same time the acceptance of foreign evidence, such as approvals from reference agencies, can be expected to improve. Early movers who build dossiers to international standards capture both effects simultaneously.

4. Practical recommendations

1. For products already approved by ANVISA, ANMAT and other regional reference agencies, prioritize them in the Paraguay submission sequence and present the original approval conclusions completely in the dossier.
2. When arguing eligibility for the simplified procedure, cite both the current annual list and the published bilateral agreements under Article 8, inc. a), rather than relying on either source alone.
3. Follow the news section of the DINAVISA website, because international cooperation developments tend to appear there ahead of formal regulatory amendments.
4. Factor the rising enforcement risk faced by uncertified products into the channel strategy, and reinforce the market advantage of regularly certified goods in distributor discussions.

The border statistics cited above also illustrate why enforcement intensity matters to legitimate operators. Seizure volumes of this size indicate an active parallel channel, and every unit of that channel that enforcement removes is demand that redirects toward certified supply. Manufacturers sometimes read enforcement news as background noise, but in market terms it operates as a subsidy to compliant products and a growing tax on informal ones.

5. Verification checklist

• □ The current annual list and the published bilateral agreements have been checked
• □ Products approved by ANVISA / ANMAT have been prioritized in the submission sequence
• □ The news section of the DINAVISA website is being followed
• □ The IMDRF membership category is pending verification against the official IMDRF list (practical estimate)
• □ The channel strategy takes account of tighter enforcement

Regulatory information verified as of October 29, 2026.

GRZAN provides registration and post-market compliance support for medical device manufacturers, importers and authorized representatives in Paraguay. For assistance with simplified procedure strategy or any other regulatory matter, contact info@grzanglobal.com.