Import & Export Requirements for Used Medical Equipment in North America
| Country | Tariffs | Licensing/permits | Regulations | Customs procedures | Miscellaneous notes |
|---|---|---|---|---|---|
| North America Region | |||||
| Antigua and Barbuda | 0% | Health ministry approval required for used medical equipment. | Used medical equipment must meet health and safety standards. | - Invoice, bill of lading, and health certification - CE Mark certification - Equipment may require inspection upon arrival by health authorities. | |
| The Bahamas | - Typically, 42% Some used medical equipment may qualify for duty - Free status depending on the category. | Import permits are required from the ministry of health. | Used medical equipment must comply with local health and safety standards. | Commercial invoice, certificate of origin, bill of lading, technical documentation. | The ministry of health does not generally purchase used medical equipment. |
| Barbados | 0% to 20% | - Import license may be required for used medical equipment - Approval from the Barbados National Standards Institution (BNSI) may be necessary. | Equipment must comply with health and safety standards. | Certificate of origin, bill of lading, technical documentation. | |
| Belize | 0% to 120% | Import license required. | - Used medical equipment must be registered with the Ministry of Health. - The equipment must meet local health and safety standards. - Labeling and packaging must comply with Belize Bureau of Standards (BBS) regulations. - Equipment may be subject to inspection for compliance with national health regulations. | - Commercial invoice, certificate of origin, bill of lading, technical documentation - Possibly sanitary or phyto sanitary certificates. | |
| Canada | It depends on the classification of the medical equipment (hs code). | - Medical Device Establishment License (MDEL) is required for importers of used medical equipment. - Importers must ensure that foreign distributors or manufacturers have an MDEL. | - Used medical equipment must comply with Health Canada’s Medical Device Regulations (MDR) and Food and Drugs Act (FDA). - Devices must be safe, effective, and meet quality standards. - All used devices must be free from contamination and have valid certifications. | - Commercial invoice, bill of lading, certificate of origin, and technical documentation - Canada Border Services Agency (CBSA) enforces compliance with Health Canada regulations. - Form B3 (customs coding form) required for clearance. | - Importation of used medical devices may be subject to stricter compliance checks. - Bilingual labeling (English and French) may be required for packaging. Québec - Specific language requirements for labeling may apply. |
| Costa Rica | - 1%. Value Added tax (VAT): 13% - Excise taxes: Specific excise taxes do not typically apply to medical equipment but be aware of any changes or additional levies. | - Import permits required from the Ministry of Health - Certificates must include quantitative - Qualitative analysis, good manufacturing practices, and free sale certificates. - U.S. FDA authorizations for medical devices are recognized without additional evaluation by the Ministry of Health. | - Sanitary regulations equipment must comply with local health and safety standards. - Refurbished medical equipment must be registered with the Ministry of Health. - Costa Rican government accepts U.S. commercial and product standards. - Certification to ISO standards is voluntary but can be beneficial. - For imports from CAFTA countries, certification of the origin of goods must be presented, but no specific format is required. | - Commercial invoices, bills of lading, and airway bills are required. - Additional documentation such as import permits and certifications - For electronic systems, utilize the TICA system for tracking and Single Windows for streamlined processing - All import processing should be handled by a certified customs broker. - Violations of documentation laws can result in heavy fines. | |
| Cuba | Exemptions to duties potentially exist for used medical equipment. | - Individual validated licenses from the Bureau of Industry and Security (BIS) are required for the export and reexport of medical devices to Cuba. - Medical devices are not eligible for License Exception Support for the Cuban People (SCP). | There is a general policy of denial for items subject to the ear, but medicines and medical devices are typically approved for export to cuba. | - SNAP R online portal is used to submit export license applications to the BIS. - D'VIAJEROS form Commercial invoice, bill of lading, certificate of origin, and technical documentation - Used medical equipment imports might be subject to customs inspections for verification of their purpose. | |
| Dominican Republic | - Duty free for most medical equipment under CAFTA - DR agreement. | Import licenses are generally not required for used medical equipment. | - Public hospitals are not allowed to purchase used medical equipment but can accept it as a donation. - Smaller clinics may import preowned equipment, typically requiring sanitary registration to ensure compliance. - Medical equipment, including used devices, must comply with sanitary and quality standards enforced by the General Directorate of Medicines, Food, and Health Products (DIGEMAPS). - Ensure compliance with NORDOM 53 and NORDOM 407 standards for labeling. - Labels must be in Spanish and include specific product details. | - Customs Declaration Form. - Commercial invoice, bill of lading, and any documentation required by DIGEMAPS for sanitary compliance. - Certification for CAFTA - DR preferential tariff treatment should include tariff classification, origin information, and certification date. | |
| El Salvador | - 13% VAT on all imports. - Tariffs for most U.S. consumer and industrial goods are duty - Free under CAFTA DR. | - Import licenses required - Ionizing radiation devices require a permit from the Radiation Protection Directorate at the Ministry of Health. | Used or refurbished medical equipment cannot be older than 10 years. | - Public institutions usually buy new equipment; private hospitals occasionally buy refurbished equipment. Post - Sale service and technical support are crucial; companies are encouraged to partner with local distributors. |
|
| Grenada | 10% | Import license required. | No person may import medical products without a valid license. | - Applications for import licenses must be submitted via the ASYCUDA World System using Direct Trader Input (DTI). - Used medical equipment may undergo a physical inspection to ensure that it matches the information provided in the import declaration. | False declaration can result in prosecution. |
| Guatemala | Approximately 2.4%, with exceptions potentially reaching up to 15%. | - Import permit required - A medical device must be registered with the Health Council. | - Compliance with RTCA regulations for product standards and technical criteria is required, including packaging, labeling, and potentially safety standards. - As part of the CAFTA - DR agreement, these regulations are harmonized across Central America, but local interpretation and enforcement may vary. - Equipment must meet the Ministry of Health standards. | - Refurbished equipment must meet all local standards. - Commercial invoice, bill of lading, certificate of origin, and technical documents. | |
| Haiti | 0% for NGOs importers. | Must obtain an import permit from ministry of commerce. | No specific exemptions for used medical equipment. | - Importers must submit a digitized import notice form. - Commercial invoice, bill of lading, certificate of origin, and technical. | |
| Honduras | - Duty free for most medical equipment under CAFTA - DR agreement. | - Registration through ARSA. - Import permit and sanitary certificate from the General Directorate for Sanitary Regulation (DGRS). - Veterinary medicines need a permit from SENASA. | - Compliance with ARSA and DGRS regulations is mandatory for medical devices - ARSA issues sanitary registration numbers (SRN) for products. - The SRN is valid for five years. | - Complete customs forms and medical clearance forms at least three business days prior to importation. - A Certificate of Origin must be presented to claim duty - Free status under CAFTA DR. - Pay attention to documentation requirements due to ongoing restructuring of customs procedures. | - Honduran customs are strict with the evaluation of certificates of origin, and errors can result in fines and non - CAFTA import duties. |
| Jamaica | 10% to 20% | Import permit required for used medical equipment, reviewed by pharmaceutical and regulatory affairs (pra). | - Equipment must meet PRA’s health and safety standards - Must be registered/approved before importation. | - Importers must submit product info to PRA which evaluates and advises on requirements. - Commercial invoice, bill of lading, certificate of origin, and technical | |
| Mexico | - Medical devices in Mexico typically face import duties of up to 10% of their customs value. - Additionally, a customs processing fee of 0.8% of the product's customs value applies. - However, products that comply with USMCA regulations and are permanently imported into Mexico are exempt from the customs processing fee. | - Importers must be registered in the Official Register of Importers (Padrón de Importadores) maintained by the SHCP. - For used medical devices, an import permit must be requested from COFEPRIS. - The import permit requires an invoice proving the equipment is not new and a document stating the device is functioning properly. - Import permits are required for a small number of devices; they cannot be sold to a third party. | - Compliance with Mexican product safety and performance regulations is required. - Medical devices must have sanitary authorization from COFEPRIS. - Starting August 1, 2023, compliance with the Complemento Carta Porte/Bill of Lading Complement is required. - Verify if USMCA rules for origin certification apply. | - Customs Declaration Form (Pedimento de Importación). - Commercial invoice (in Spanish), bill of lading, and documentation proving compliance with Mexican safety and performance regulations. - Use of an authorized customs broker is required. - Customs clearance can be time consuming. | Import permits are mandatory for used medical devices; declaring them as spare parts or accessories is considered a bad practice and is not compliant with regulations. |
| Nicaragua | - Duty free for most medical equipment under CAFTA - DR agreement. | Importers must obtain sanitary registration from the ministry of health’s pharmaceutical office and pay relevant fees. | - Compliance with Nicaraguan health and safety standards is required. - The Ministry of Health’s Pharmaceutical Office requires documentation demonstrating the safety and effectiveness of used medical equipment. - Ensure that all imported medical equipment complies with Nicaraguan technical and sanitary regulations. | - Bill of lading Packing list - Original invoice Declaration of invoice authenticity - Permits (if required) - Certificate of origin (to determine applicability of CAFTA - DR and other trade agreements) - Register as a taxpayer with DGI and provide proof of fiscal solvency. | |
| Panama | The trade promotion agreement (tpa) between the u.s. and panama allows for duty free entry. | - No special import licenses are required for used medical equipment. - Operation License is required for entities involved in manufacturing, packaging, import, export, distribution, marketing, or storage. - This license is valid for three years. | - Goods must comply with the Panamanian Harmonized System (HS) or Tariff Nomenclature - Products must comply with technical specifications set by the National Interinstitutional Technical Committee (CTNI). - A Technical Verification Certificate is required for public institutions, valid for five years. | - Medical devices require marketing authorization for import, distribution, and commercialization, valid for ten years. - Commercial invoice, bill of lading, certificate of origin, export certificate, packing list... | |
| Trinidad and Tobago | 20% | Import license may be required for certain used medical equipment. | Products must comply with tts76 labeling standards, including product description, country of origin, and safety information. | A customs broker is required for imports; submit caricom area invoice, supplier’s invoice, bill of lading, c75/c76 form, certificate of origin, and any relevant health/sanitary certificates to customs for clearance. | Medical equipment is subject to inspection and may require certification for safety and compliance. |
| U.S. Export Regulations | - Export Control Classification Number (ECCN) Classification Code - Regulation Number BIS (Bureau of Industry and Security, located in the US Department of commerce) issues the BIS - 748P Application Form and the permit | - Compliance with U.S. - Export Administration Regulations (EAR) and Office of Foreign Assets Control (OFAC) requirements. | - BIS 748P form - Detailed specifications of the equipment are required. |
North America
Antigua and Barbuda
https://www.certvalue.com/ce-mark-certification-in-antigua-and-barbuda/
The Bahamas
https://www.bahamasmaritime.com/wp-content/uploads/2023/10/MN041-Medical-Stores.pdf
https://www.privacyshield.gov/ps/article?id=Bahamas-customs-regulations
Barbados
https://www.trade.gov/country-commercial-guides/barbados-import-tariffs
https://www.stopfakes.gov/article?id=Barbados-Labeling-Marking-Requirements
https://morganshipping.com/country/barbados
https://www.latinamericancargo.com/exporting-to-barbados-a-trade-export-guide/
Belize
https://www.trade.gov/country-commercial-guides/belize-customs-regulations
https://www.customs.gov.bz/ttpg.html
https://bts.gov.bz/wp-content/uploads/2019/10/GST-IMPORTED-GOODS.pdf
Canada
https://www.cbsa-asfc.gc.ca/import/guide-eng.html
https://www.trade.gov/country-commercial-guides/canada-customs-regulations
Costa Rica
https://www.trade.gov/country-commercial-guides/costa-rica-import-requirements-and-documentation
https://startabroad.com/locations/costa-rica-country-guide/costa-rica-shipping/
https://www.emergobyul.com/resources/costa-rica-regulatory-approval-process-medical-and-ivd-devices
Cuba
https://opapeleo.com/en/featured/cuban-customs-guide-2024/
https://www.bis.gov/ear/title-15/subtitle-b/chapter-vii/subchapter-c/part-746/ss-7462-cuba
https://www.bis.doc.gov/index.php/documents/pdfs/2484-bis-cuba-consolidated-faqs-1/file
Dominican Republic
El Salvador
https://www.trade.gov/country-commercial-guides/el-salvador-medical-equipment
https://www.privacyshield.gov/ps/article?id=Medical-Equipment-El-Salvador
Grenada
Guatemala
https://www.trade.gov/country-commercial-guides/guatemala-import-requirements-and-documentation
https://www.privacyshield.gov/ps/article?id=Guatemala-Import-Requirements-and-Documentation
Haiti
https://www.trade.gov/country-commercial-guides/haiti-customs-regulations
Honduras
https://www.trade.gov/country-commercial-guides/honduras-customs-regulations
https://hn.usembassy.gov/message-for-u-s-citizens-increase-in-confiscation-of-medical-supplies/
Jamaica
https://www.trade.gov/country-commercial-guides/jamaica-customs-regulations
https://www.moh.gov.jm/standards-and-regulation-division/
https://jamaicatradeportal.gov.jm/en-gb/search-procedure/view/45
Mexico
https://www.trade.gov/knowledge-product/mexico-import-tariffs
https://www.lexology.com/library/detail.aspx?g=5a002cb2-1933-4b82-b937-058d345d3375
Nicaragua
https://www.trade.gov/country-commercial-guides/nicaragua-standards-trade
Panama
https://www.trade.gov/country-commercial-guides/panama-medical-equipment
Trinidad and Tobago
https://www.trade.gov/country-commercial-guides/trinidad-and-tobago-customs-regulations
https://www.finance.gov.tt/services/customs-and-excise/importing-and-exporting/#importNegativeList
https://tradeind.gov.tt/wp-content/uploads/2016/03/National-Policy-on-Imported-Used-Goods.pdf