Import & Export Requirements for Used Medical Equipment in South America
| Country | Licensing/permits | Regulations | Customs procedures | Miscellaneous notes |
|---|---|---|---|---|
| South America | ||||
| Argentina | - Medical devices must be registered with ANMAT before import. Registration is valid for 5 years (renewed within 30 business days before expiration) - Import license (TAD system) is required from ANMAT | - Used/refurbished medical equipment allowed only if the equipment has been refurbished by the original manufacturer or by an approved technical service, certified via a detailed refurbishment technical report with tests, standards and affirmation device meets original specs - Devices must meet Administración Nacional de Medicamentos, Alimentos y Tecnología Médica’s (ANMAT) GMP or MDSAP/ISO 13485 standards as per Disposition 3266‑2013 | - Technical documentation: Annex lllA/B/C depending on classification of the equipment, Certificate of Free Sale (CFS), local GMP compliance, Commercial invoice, Packing List, shipping documents and Registration Certificate | - Recent deregulation (Decree 273/2025) removes bureaucratic barriers for general used capital goods, but medical equipment remains under strict exception and documentation requirements - Labels and instructions must be in Spanish |
| Bolivia | - No special licensing required for used/refurbished medical equipment. - Medical equipment treated the same as new - Registration with AGEMED required - Importers are required to submit three physical samples of the device to INLASA for verification | - Must follow government procurement regulations for public sector purchases. | - Sworn Declaration Form: Required by the National Customs Office if the product does not require inspection Cost is 1% of FOB (Free on Board) product value - Product Verification: If required by inspection companies, the cost is 1.75% of the FOB product value - Pre-shipment Inspection: Not required for most medical equipment. - Bolivian Customs will inspect the equipment upon arrival - Commercial invoice, Certificate of Origin and Bill of Lading | |
| Brazil | - Medical Product Import License and Operating Authorization (AFE) required - Importers and equipment registration with ANVISA (Agência Nacional de Vigilância Sanitária) | - Refurbished equipment is not banned but subject to strict regulation: it must meet safety, performance, and hygiene standards equivalent to new equipment - The refurbishment must be performed by the original manufacturer or authorized technical service provider and be accompanied by a certification of conformity - Reprocessed single-use devices are not allowed for import - Used equipment that is not refurbished or lacks traceability/certification is prohibited | - The following documents must be submitted via the SISCOMEX system: commercial invoice, Bill of Lading, ANVISA import license, and Certificate of Origin - Certificate of Free Sale (CFS) and detailed refurbishment report required for refurbished goods - Customs clearance can take 15-60 days depending on device | - Items must be labeled in Portuguese and meet Brazilian standards - Devices imported for donation or humanitarian use require additional authorization from ANVISA and the Ministry of Health |
| Chile | - All medical equipment (including refurbished) must be registered with the Institute of Public Health (ISP) under the Ministry of Health - Importers must hold a valid Sanitary Registration and be authorized by ISP | - Must comply with Chilean health regulations, including safety and efficacy standards. - The ISP oversees these regulations and may require additional certifications. | - Commercial invoice, Certificate of Origin, Bill of Lading, ISP registration (if applicable) and sanitary registration - Technical report and certificate of refurbishment recommeded for used medicament. Clearance is done via the SICEX platform - Equipment may undergo additional inspections to ensure compliance with national standards | - Importing used medical equipment can be subject to specific restrictions if the equipment is considered obsolete or hazardous. - Labels must be in Spanish - Regular updates to import regulations may occur, so staying informed through official channels is crucial. |
| Colombia | - Sanitary registration from the Colombian National Institute for Food and Drug Surveillance (INVIMA). | - Colombian regulations on health, safety, and efficacy. - INVIMA regulates these standards and may require additional certifications, particularly for used or refurbished equipment. - Specific technical and operational standards to ensure they are safe and functional. - Used equipment must be 5 years old or younger (Decree 4725 of 2005). | - Commercial invoice, certificate of origin, bill of lading, and the relevant sanitary registration. - May be subject to additional inspections and checks to ensure compliance with national standards. - Customs valuation may also include an assessment of the equipment’s residual life and functionality. | |
| Ecuador | - Private hospitals and clinics require a permit to import used equipment. - Must be registered with the Ministry of Industry and Productivity's Quality Department. | - Equipment must be refurbished and come with a one year warranty. - Must comply with Ecuadorian standards and obtain INEN 1 certificate. | - Present the INEN - 1 certificate at customs. - Submit all required registration and technical documents. - Conformity Assessment required (INEN 1). | - Only private entities (hospitals, clinics) can import used medical equipment. |
| Paraguay | - Importers must obtain an import license from the Ministry of Health. - Additional permits may be required from the National Directorate of Sanitary Surveillance (DINAVISA). | - Used medical equipment must be labeled with the country of origin. - Expiration dates must be clearly stated where applicable. - Compliance with local health and safety standards is required - Import operations for used medical equipment must be processed through authorized banks with notification to the Central Bank of Paraguay. | - The CET must be paid to Paraguay’s customs authorities. - If used medical equipment is re-exported to another Mercosur country, the CET must be paid again upon importation into that country - Documentation must be certified, and a customs broker must be employed for processing - Commercial invoices, certificates of origin, and cargo manifests, which must be certified by the Paraguayan consulate or at the Ministry of Foreign Affairs in Paraguay | |
| Peru | - Sanitary registry: managed by the Dirección General de Medicamentos, Drogas e Insumos (DIGEMID) under the Ministry of Health (MINSA) | - Used medical equipment is only permitted for purchase by individual physicians for personal use, not for institutional use | - Commercial invoices, certificates of origin, and cargo manifests. - Documents must be certified by the Peruvian consulate or the Ministry of Foreign Affairs in Peru. - Equipment is subject to customs inspection upon arrival. | - The Peruvian market prefers new equipment with strong post sales support |
| Uruguay | - Sanitary registration managed by the Ministry of Public Health (MSP). | - Used medical equipment must meet health and safety standards set by the Ministry of Public Health (MSP). - Compliance with local regulations and international standards is required. - Equipment must be inspected and approved before use in healthcare settings - Importers must appoint a local representative or distributor who will be responsible for regulatory compliance and registration. | - Commercial invoices, certificates of origin, and cargo manifests. - These must be certified by the Uruguayan consulate or the Ministry of Foreign Affairs. - Equipment is subject to customs inspection upon arrival. - Documentation and compliance with regulatory standards must be verified. | - All documents must be written in Spanish. |
| Venezuela | - Required approval from the Ministry of Health (MINSALUD) - Import permits required and are managed by various ministries depending on the equipment type. | - Import of refurbished medical devices is only allowed in the private sector - Used equipment must have been registered when new, and MINSALUD does not accept registration requests for used equipment - The local importer or distributor must manage this process. | - Customs documents must be in Spanish, including the commercial invoice, Bill of Lading, packing list, Certificate of Origin and any required special certificates. | - Importers must ensure technical support and service availability. Over - Invoicing is illegal and may lead to fines or auctioning of goods. |
South America
Argentina
https://www.trade.gov/country-commercial-guides/argentina-prohibited-and-restricted-imports
Bolivia
Brazil
Chile
https://www.trade.gov/country-commercial-guides/chile-import-requirements-and-documentation
Colombia
https://iamers.org/2015/05/pre-owned-medical-importation-by-country/
https://www.trade.gov/country-commercial-guides/colombia-import-requirements-and-documentation
Ecuador
https://mdrc-consulting.com/ecuador-medical-device-registration-guide-en/
Ecuador – Licensing Requirements for Professional Services
Paraguay
https://www.trade.gov/country-commercial-guides/paraguay-import-requirements-documentation
Peru
https://www.privacyshield.gov/ps/article?id=Peru-Medical-Devices
Uruguay
https://iamers.org/2015/05/pre-owned-medical-importation-by-country/
https://www.trade.gov/country-commercial-guides/uruguay-import-tariffs
Venezuela
https://legacy.export.gov/article?id=Venezuela-Licensing-Requirements-for-Professional-Services