Import & Export Requirements for Used Medical Equipment in South America
| Country | Tariffs | Licensing/permits | Regulations | Customs procedures | Miscellaneous notes |
|---|---|---|---|---|---|
| South America | |||||
| Argentina | No importation of used and refurbished medical equipment is allowed. | ||||
| Bolivia | 10% | - No special licensing required for used/refurbished medical equipment. - Treated the same as new. - Registration with AGEMED required Three samples 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, bill of lading... | |
| Brazil | No importation allowed. | ||||
| Chile | Duty free | - 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, and sanitary registration. - 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. - Regular updates to import regulations may occur, so staying informed through official channels is crucial. |
|
| Colombia | Duty free | 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 | Average applied most favored nation (mfn) tariff rate is 7.6% for industrial products. | - 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 | 0% to 30% | - 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 | - Medical devices from the US can enter duty - Free under the U.S. - Peru Trade Promotion Agreement (PTPA), provided a U.S. certificate of origin is presented. - Specific tariff rates for used medical equipment are not detailed | 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 | - Uruguay’s applied import tariffs generally range from 0% to 25%. - Medical equipment may fall under specific tariff codes which can affect the exact rate. - Uruguay is a Mercosur member, so the Common External Tariff (CET) could apply, ranging from 0% to 35%, though Uruguay often applies lower rates. | 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 | 0% to 5% | - 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