CURRENT AFFAIRS
ANMAT Provision 224/2026 and the import of used medical equipment
Executive summary
ANMAT Provision 224/2026, published in the Official Gazette on 2 February 2026, repeals Provision 806/2007 and adapts the regulatory framework for importing used medical products to Decree 273/2025. The measure eliminates the Certificate for the Import of Used Goods (CIBU) as a prior requirement, enables direct importation by the final user and broadens the universe of recognized refurbishing establishments. In operational terms, the provision reduces entry barriers to the Argentine market for second-hand medical equipment from countries with internationally recognized technical and health standards.
The measure forms part of the import deregulation process pursued by the La Libertad Avanza government, whose central axis is the reduction of administrative intermediation in order to expand access to lower-cost goods. The official argument is explicit: to make it easier for smaller clinics and hospitals to access more modern equipment at more affordable prices, reducing referrals and improving the territorial coverage of the health system.
From the perspective of the bilateral import structure, the measure has implications that the official discourse does not address.
1. The previous regulatory framework and the changes introduced
The previous regime, established by Resolution 909/94 of the former Ministry of Economy and ANMAT Provision 806/2007, organized the import of used goods under HS84 to HS90 around the CIBU as a control instrument. The CIBU operated as an entry filter: it required proof of functionality, identification of the refurbishing establishment and product traceability. Its elimination does not remove technical safety requirements — the product must still hold a valid ANMAT registration or apply for one — but it disables the prior control mechanism before importation.
Provision 224/2026 establishes three routes of entry for used medical equipment:
— Products refurbished by an establishment authorized by the original manufacturer.
— Products refurbished by establishments complying with standards from countries with internationally recognized standards (EU, United States, Japan, among others implicitly).
— Products that do not require refurbishment, with certification of that fact, or that will be refurbished in Argentina by an authorized establishment.
Importation may be carried out directly by the final user or by a company authorized to operate as an importer or manufacturer of medical products.
2. Structural implications for technological dependency
CEIBO’s sector report on Argentina’s medical-industrial complex (HS90, 2003–2025) documents that Germany maintains a structurally stable 15–21% share of Argentine HS90 imports across very different macroeconomic cycles. This stability does not respond to administrative conditions — it persists in both restrictive and open periods — but to positional dependency: Argentina imports from Germany equipment for which there are no local alternatives or immediate functional substitutes, particularly active implants (HS9021), precision instruments and specialized diagnostic equipment.
The opening to used equipment modifies this structure in three relevant ways:
Competitive pressure on new first-line equipment. The segment of public hospitals and smaller clinics — which historically imported new German, US or Japanese equipment with institutional financing — can now access used equipment from those same origins at substantially lower prices. This does not displace Germany from the high-end technology segment, but it may erode its position in mid-range segments where price exposure is greater.
Repositioning of the secondary market as an access channel. High-complexity medical equipment has long life cycles. A previous-generation CT scanner or MRI unit refurbished in Europe with CE certification can operate with full clinical functionality for additional years. The opening creates a formal channel for a market that previously operated informally or through temporary imports. The main beneficiaries on the supply side are European distributors specialized in refurbished equipment, a consolidated segment in Germany, Austria and the Netherlands.
Impact on local manufacturers in mid-range segments. Argentina’s medical-device industry is present in medium-low complexity segments: orthopedic implants, rehabilitation equipment and certain diagnostic instruments. In these segments, competition from imported used equipment — at significantly lower prices than new equipment — may displace local production without any process of technological upgrading. The risk of reverse substitution documented in the automotive sector has an analogue in the medical sector.
3. Positioning of international suppliers
The measure does not affect all international suppliers uniformly. Its differential effect depends on each origin’s position in the medical-equipment value chain.
Germany maintains its position in segments of functional non-substitutability — cardiac stimulators, cardio-defibrillators, specialized diagnostic systems — where used German equipment remains preferable to new equipment from alternative origins due to technical specification, after-sales service and system compatibility. At the same time, the European refurbished-equipment market is highly developed in Germany: specialized firms such as Soma Technology, Block Imaging or their European equivalents operate in this space. The Argentine opening may create opportunities for this segment of the German ecosystem, which until now had no formal access to the Argentine market.
China occupies a different position. Its penetration of the Argentine HS90 market is concentrated in standardized price-competitive equipment — mechanotherapy, Doppler ultrasound, mid-range computed tomography. In these segments, new Chinese equipment already operates with a price advantage. First-generation used Chinese equipment competes against newer generations of Chinese equipment, not necessarily against new European equipment. The net effect on China’s share is ambiguous.
The United States maintains strong positions in precision analytical equipment — chromatography, spectroscopy — where the refurbished-equipment market is consolidated and specialized suppliers have an established trajectory. The opening may benefit already established distribution channels.
4. What the measure does not resolve
Provision 224/2026 does not address the dimension CEIBO identifies as central to the structure of technological dependency: the loan-for-use model and service contracts associated with high-complexity equipment. A hospital that obtains a refurbished CT scanner still depends on supplies, software updates and technical service from the original manufacturer or its authorized network. Reducing the access cost of the equipment does not modify the structure of derived service flows generated by the supplier-user relationship over the equipment’s life cycle.
In this sense, opening the market to used equipment may broaden access without altering positional dependency. It is an access policy, not a capability-development policy.
5. Relevance for the Argentina–Germany bilateral relationship
The measure forms part of the broader import liberalization process of 2024–2026. CEIBO’s report on 2024–2025 trends documents that import opening expands volumes without reorganizing who supplies what: China accelerates, Germany maintains its position in specification-based niches, and the structure of positional dependency is reproduced. Provision 224/2026 operates within that logic: it modifies access conditions to the secondary market without altering the structural determinants of distribution by origin.
For the German ecosystem, the measure opens a window in the refurbished-equipment segment that complements — without displacing — its existing position in the market for new high-complexity equipment. For Argentine sectoral actors, it represents a reduction in access costs with a potential negative impact on local mid-range producers. For CEIBO’s analysis, it confirms that the vector of change in Argentina’s medical-industrial complex is trade-opening policy, not industrial upgrading policy.