Most MedTech companies entering Latin America focus on the Big Five and ignore the smaller markets where 70+ million patients live. This edition covers Peru's pharmacovigilance update, Panama's 10-year registration validity, the Dominican Republic's DIGEMAPS framework, El Salvador's annual fees, and Brazil's TCU-ordered CONITEC overhaul.
Peru · Panama · Dominican Republic · El Salvador · Brazil
Most MedTech companies entering Latin America focus on the Big Five - Mexico, Brazil, Colombia, Argentina, and Chile - and ignore the smaller markets where tens of millions of patients and meaningful revenue opportunities exist. That calculus is changing. This week: Peru modernizes pharmacovigilance, Panama maintains a uniquely long 10-year registration validity, the Dominican Republic formalizes its device pathway under DIGEMAPS, El Salvador activates annual fees, and Brazil's TCU orders a structural overhaul of CONITEC's device reimbursement process.
Peru's Ministry of Health issued Resolution Ministerial 049-2025/MINSA, updating the Manual of Good Pharmacovigilance Practices. The revised manual reinforces adverse event monitoring requirements for medical devices alongside medicines, with specific reporting obligations for device identification details, root cause analysis, and corrective actions. Separately, draft IVD regulation under Resolution Ministerial 607-2024/MINSA is advancing through MINSA with stricter regulatory controls for in vitro diagnostics.
Why It Matters: For device companies already registered in Peru, techno-vigilance reporting is no longer a light-touch obligation - it is a structured process with defined data requirements. Companies should audit their Peruvian adverse event reporting workflows now. For IVD manufacturers, the incoming framework will tighten registration requirements beyond the current Law 29459 baseline. Early compliance planning avoids downstream disruption. DIGEMID device registration timelines remain 60 to 120 days depending on risk class, with certificates valid for 5 years.
Panama maintains one of the most manufacturer-friendly device registration frameworks in the region. The Ministry of Health (MINSA) / DNDM grants device registrations valid for 10 years - double the 5-year standard in Brazil, Mexico, Argentina, Chile, Peru, and most other LATAM markets. Official review is 60 working days, with a possible 60-day extension if additional information is requested. Classification follows GHTF/IMDRF rules, with Spanish documentation required.
Bottom Line: For companies building a multi-country LATAM footprint, Panama offers exceptional registration economics - one approval and ten years of commercial access, compared to the two renewals required over the same period in Brazil or Mexico. Combined with Panama's free trade zone infrastructure and Spanish-language alignment with the broader region, it functions as both a market and a logistics hub for serving Central America and the Caribbean.
The Dominican Republic's DIGEMAPS continues implementation of Decree 284-21, which modernized the sanitary registration framework and established a zero bureaucracy simplification program. Medical devices and IVDs are classified as Class I, IIa, IIb, and III, with registration timelines of up to 240 working days for new applications. Local Authorized Representatives are mandatory for foreign manufacturers, and a local trademark certificate from the National Industrial Property Office is required as part of the registration dossier. Registration fees are USD 190 per device, with 5-year validity. Audit or inspection is not required for foreign manufacturers - only local manufacturers face on-site inspection.
What to Focus On: The Dominican Republic's 240-working-day timeline is longer than most of the region but is offset by minimal audit burden, low fees, and license transferability. For companies seeking Caribbean market presence, the DR offers a structured pathway with predictable requirements - but the local trademark certificate requirement catches many manufacturers off guard and should be initiated early in the registration process.
El Salvador's Direccion Nacional de Medicamentos (DNM) confirmed the annual maintenance fee schedule effective January 1, 2026 for all registered health products. Medical devices and other healthcare technologies pay USD 85 per year, while pharmaceutical products pay USD 100 and cosmetic/hygiene products pay USD 35. The fee must be paid within the first three months of each calendar year to maintain valid registration. Device registration timelines remain 5 to 6 months depending on classification, with registration fees of USD 75 for new applications.
Why It Matters: Companies with El Salvador device registrations should ensure Q1 annual fees are paid on time to avoid registration lapse. For new market entrants, El Salvador remains one of the lowest-cost registration pathways in the region - but the annual maintenance obligation is a new cost line item that should be included in multi-year market access budgeting.
Brazil's Federal Court of Accounts (TCU) issued Ruling 674/2026 on March 18, 2026, ordering the Ministry of Health and CONITEC to implement structural improvements to the Health Technology Assessment (HTA) process for incorporation of devices and other technologies into the SUS public health system. The ruling identified 16 deficiencies including conflicts of interest, inadequate economic evaluations, recommendations based on lower-quality evidence, missed statutory deadlines, and delays in making incorporated technologies available. The Ministry of Health and DGITS must submit action plans within 90 days covering HTA methodology for ultra-rare diseases, five-year price monitoring of incorporated technologies, and controls to ensure centralized procurement respects the price ceiling presented during incorporation.
Bottom Line: For MedTech companies pursuing SUS reimbursement, CONITEC is entering a period of methodological and procedural reform that will reshape how device HTA submissions are evaluated. Companies with pending or planned incorporation requests should expect more rigorous economic evaluations, stronger budget impact analyses, and stricter price commitments over a five-year post-incorporation horizon. The ruling also increases the importance of manufacturer participation in CONITEC proceedings - one of the 16 deficiencies was the absence of technology-holder participation in the HTA process.
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