Wholesale Respiratory Devices for Argentina

The 2026 bilateral trade agreement is eliminating tariffs across 221 tariff positions, including key medical device categories. Previously, Argentine customs applied duties of 0–16% under Mercosur's common external tariff schedule, depending on HS code classification.

The tariff reductions are being phased in progressively — not all positions drop to 0% immediately. For respiratory devices specifically, the trajectory is favorable, but distributors should still factor in Argentina's 21% IVA (value-added tax) and AFIP statistical fees when calculating landed costs. SysMed provides updated tariff guidance and NCM classification codes specific to each Resvent product for accurate cost projections.

Timelines depend on ANMAT's four-tier risk classification. Class I and II devices (most CPAP and BiPAP systems) undergo technical evaluation in 15–30 working days. Class III and IV devices (ICU ventilators, life-support equipment) require 60–120 working days and may need additional clinical data.

All ANMAT registrations are valid for 5 years. Common delays stem from formatting errors in the product master file — ANMAT expects a specific dossier structure that differs from FDA or EU submissions. SysMed provides documentation pre-formatted to ANMAT's Disposición requirements, including risk management files (ISO 14971), GMP evidence, and all labeling in Rioplatense Spanish, to minimize back-and-forth with the agency.

Argentine customs (AFIP/Aduana) requires several documents beyond the standard commercial invoice and packing list. Key requirements include: NCM tariff classification codes (Argentina uses the Mercosur Nomenclatura Común, not standard HS codes), certificates of origin, and a despacho de importación filed through an authorized customs broker.

Medical devices also require proof of ANMAT registration at the time of customs clearance — unregistered devices will be held. SysMed provides complete customs documentation with NCM codes specific to each Resvent product, formatted for Argentine customs requirements. We flag any products that may be subject to non-automatic import licensing (SIMI) requirements, which can add processing time if not anticipated.

PAMI (Programa de Atención Médica Integral) is Argentina's largest public health insurer, covering over 5 million retirees and pensioners. It operates as a centralized purchasing organization for medical equipment, running formal licitación (tender) processes with specific documentation, pricing, and delivery requirements.

PAMI tenders for respiratory equipment — particularly CPAP and BiPAP for home therapy programs — represent some of the highest-volume procurement opportunities in the Argentine market. Winning positions require ANMAT-registered products, competitive volume pricing, and the ability to demonstrate after-sales service capability. SysMed helps distributors prepare tender responses with product technical sheets, ANMAT registration evidence, and pricing structures aligned to PAMI volume expectations.

All SysMed wholesale transactions are denominated in U.S. dollars (USD), regardless of destination market. For Argentine buyers, this eliminates the pricing uncertainty that comes with peso fluctuations between quote acceptance and payment settlement.

We also offer flexible payment terms designed specifically for the Argentine market's cash-flow realities — including extended net terms for established partners and framework agreements that lock in per-unit pricing across multiple shipments. This structure lets distributors quote their downstream hospital and clinic customers with predictable margins, even when the ARS/USD rate is moving.