Import & Export Requirements for Used Medical Equipment in North America
| Country | Licensing/permits | Regulations | Customs procedures | Miscellaneous notes |
|---|---|---|---|---|
| North America Region | ||||
| Antigua and Barbuda | - Ministry of Health 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 | - 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 and technical documentation. | - The Ministry of Health does not generally purchase used medical equipment. |
| Barbados | - 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 | - 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 | - 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 | - 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 | - 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). - A sanitary registration or import license issued by the Ministry of Public Health is required | - Medical devices must meet Cuban technical, safety and sanitary standards. These standards typically require proof of quality (e.g. CE marking). Used or refurbished equipment will be subject to stricter scrutiny to ensure safety and suitability for healthcare use - (U.S.- Only) 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. | - (U.S.- Only) 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 | - 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 | - 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. | - Commercial invoice, Bill of Lading, and other required documents - Customs requires specific documentation for CAFTA-DR preference and can request additional documents for transshipment | - 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 | - 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 declarations can result in prosecution. |
| Guatemala | - Import permit required - 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 | - Importers must obtain an import permit from the 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 | - 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. - Attention must be paid 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 | - 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 | - 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. - USMCA rules for origin certification may 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 | - 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 | - 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 and Packing List | |
| Trinidad and Tobago | - An 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