Optics & medical devices
Import of optical equipment and instruments and medical devices, with ANMAT intervention.
We support the import of optical equipment and instruments and of medical devices, two categories that share this vertical but not always the same process.
Medical instruments and equipment in general —diagnostic equipment, surgical supplies, devices— must be registered with ANMAT (Registro de Productores y Productos de Tecnología Médica, RPPTM), through authorized manufacturers or importers. Sunglasses with zero optical power, on the other hand, aren't registered with ANMAT at all: since 2019, jurisdiction belongs to the Secretaría de Industria y Comercio. The current technical regulation is Resolución SIyC 313/2025, which lists them in its Anexo II and requires proof of compliance with the ISO 12312-1 standard via a Declaración Jurada de Conformidad. Sunglasses and sun filters that are medically prescribed fall outside that regulation and follow their own health-authority process. We take care of the correct framing by product type and of the documentation each process requires.
- Precision optical equipment and instruments
- Medical devices and equipment (diagnostic, supplies, surgical)
- Neutral-power sunglasses
- Registration and authorization with ANMAT
- Professional technical direction when regulation requires it
- Regulatory and documentary compliance from start to finish
Regulations and agencies involved
ANMAT — Registro de Productores y Productos de Tecnología Médica (RPPTM)
Mandatory registration for instruments, equipment, implants, and medical devices before import and commercialization. Covers both the company (manufacturer or importer) and the product, with requirements that vary by risk class (I through IV).
Sunglasses — Resolución SIyC 313/2025
Sunglasses with zero optical power aren't registered with ANMAT: since 2019, jurisdiction belongs to the Secretaría de Industria y Comercio. Anexo II of Resolución SIyC 313/2025 requires proof of compliance with the ISO 12312-1 standard via a Declaración Jurada de Conformidad. Sunglasses and sun filters that are medically prescribed fall outside this regulation and follow their own health-authority process.
ANMAT — used or refurbished medical products (Disposición 224/2026)
Allowed if the product has a current ANMAT registration and isn't excluded — single-use products are excluded. Requirements depend on the risk class: class I and II with notice filed after customs clearance; class III and IV require prior authorization. Only product users or authorized facilities can import.
Frequently asked questions
Do you operate in any of these sectors?
Tell us about your operation and we'll advise you at no cost on regime, duties, and logistics.