Import & Export Requirements for Used Medical Equipment in Asia

CountryTariffsLicensing/permitsRegulationsCustoms proceduresMiscellaneous
notes
Asia
Afghanistan0% to 20%, depending on the specific classification of the equipment under the harmonized system (hs) tariff classification.- Requires business and activity licenses.
- Application must be made to the General Directory of Pharmacy Affairs.
- Pro forma statement required.
- Must comply with the National Licensed Drugs List.
- Special cases may require approval from the National Medicine and Food Board.
- Present Import Permit to Customs.
- Customs notifies the General Directory of Pharmacy Affairs of arrival.
- Quarantine and testing of samples.
- If quality is confirmed, an import permit is issued. Non
- Compliance results in seizure and disposal of goods.
- Process can take 3 to 15 days.
- No quotas apply for licenses Non
- Utilization of permits incurs no penalty.
- Permits are non transferable.
Armenia- Subject to general customs tariffs for medical devices, currently averaging over 10% due to EAEU membership.
- Specific rates for used medical equipment may vary.
- Import and sale of medical equipment are authorized without state registration.
- However, updates and harmonization of local legislation are planned due to EAEU accession.
- A Certificate of state registration from another EAEU member state is recognized.
- Must comply with EAEU technical regulations.
- Registration of medical products and their safety, efficacy, and quality must be managed, even if state registration is not required for equipment.
- Customs declaration required with supporting documents, including commercial invoices.
- Online declaration process (DTI) must be used to reduce personal contact with customs officials.
- Compliance with labeling standards is essential.
- Armenia's legislation is evolving to align with EAEU requirements, impacting the future import of medical equipment.
Azerbaijan- Simplified tariff regime established in 2018, which includes rates of 0%, 5%, or 15%.
- However, the specific tariff rate applied to used medical equipment may vary depending on the classification of the equipment and its condition.
Licenses from the ministry of health required.- Mandatory registration since July 19, 2024, by the Center for Analytical Expertise
- Devices classified by risk level; Class I devices do not require registration.
- Importers need a legal entity registered in Azerbaijan, suitable storage, qualified personnel, and a quality management system.
- Import of unregistered devices is prohibited.
- Required documents include invoices, packing lists, certificates of origin, and licenses.
- Labels must be in Azerbaijani and include device name, manufacturer's info, intended use, warnings, and expiration date.
- English or Russian labels can also be included.
BahrainBahrain's national health regulatory authority (nhra) prohibits the importation of used or refurbished medical devices.
BangladeshMight be duty free.Importers of used medical equipment must obtain import registration certificates (irc) from dgda.- Used medical devices are regulated under the Bangladesh Drug and Cosmetics Act of 2023.
- These devices must comply with safety and quality standards.
Certificate of free sale (cfs), iso 13485, and additional technical documentation depending on registration status.
BhutanSpecific tariff rates for used medical devices may vary; generally, rates can range from 0% to 30% depending on the device type.- Importers must secure an Import License from the DRA.
- Used medical devices must have documentation from the exporting country.
- Governed by the Medicines Act of the Kingdom of Bhutan.
- DRA evaluates the quality, safety, and efficacy of all medical devices before approval.
- Compliance with international standards (e.g., ISO, CE marking) is often required
- Registration is mandatory for all medical devices prior to importation.
- Submission of required documentation, including import licenses, certificate of free sale or equivalent registration certificates, and quality assurance certificates, is mandatory.
- Customs may perform inspections and assessments to verify compliance with health regulations.
- Clearance times can vary; planning ahead is advisable to avoid delays.
- DRA is working to improve regulatory infrastructure, including laboratory capabilities.
- Challenges include human resource limitations and the need for more robust testing facilities.
- Importers are encouraged to partner with local experts to navigate the logistics of Bhutan’s mountainous terrain effectively.
Brunei Darussalam20%Import permit required.- Used medical equipment must comply with regulations under the Ministry of Health and possibly the Brunei Medical Board
- Additional approvals may be needed if the equipment is considered critical for health services.
- Importers must register with the port of entry.
- Importers must submit completed customs declaration forms via the Brunei Darussalam National Single Window, along with supporting documents (invoices, packing lists, etc.).
- Certificates of origin and analysis may also be required.
- All imports must bear appropriate labelling and documentation.
- Importation of medical supplies must comply with halal standards, where applicable.
Cambodia- Import tariffs may vary based on the type of medical equipment; ASEAN Trade in Goods Agreement (ATIGA) eliminates tariffs on products from ASEAN countries.
- Specific rates should be confirmed with the GDCE.
Medical devices must be registered with the department of drug and food (ddf) and have a medical device registration license.- Imported medical products must undergo registration for laboratory testing.
- The registration process can take three to six months, with certificates valid for three years.
- Companies must reapply six months before expiration.
- Registration ensures compliance with safety and quality standards.
- Unregistered imports can incur fines or bans.
- Only Cambodian companies can import medical devices and IVDs.
- The import process is facilitated through the Cambodia National Single Window (CNSW) portal.
- Companies must also hold a Certificate of Corporate and Import
- Pharmaceutical License from the Ministry of Health.
- Temporary imports are allowed under specific conditions, and importers may need to pay a security deposit for duties.
- Fines for importing unregistered medical devices can reach up to KHR 10 million (approximately USD $2,500) and may include imprisonment or confiscation of devices.
ChinaNo importation of used and refurbished medical equipment is allowed.
GeorgiaMost medical devices, including used ones, are exempt from customs duty.No import license required.- Governed by general health regulations, with limited specific regulations for used medical equipment.
- Compliance with safety and quality standards may be advised.
- No registration is required for most used medical equipment.
- Specific categories (like dental materials) may require registration.
- Customs require shipping documentation that includes a thorough description of the equipment.
- The import process is generally straightforward with minimal inspections.
- The healthcare market is largely driven by out of
- Pocket payments, influencing demand for affordable equipment.
India27% to 44%Import license is required.- The import of used critical care medical equipment is regulated under the Hazardous and Other Wastes Rules.
- 27 critical care devices are prohibited for import and reuse.
- Parts/accessories up to 15% of the value of equipment may be imported for maintenance and operation
- Refurbished medical equipment cannot be sold or disposed of within five years without permission from the Director General of Foreign Trade (DGFT).
- Importers must furnish a prescribed bill of entry and full details of the value of imported goods.
- Import licenses must accompany all documentation (e.g., invoices, freight documents).
- Valuation disputes with customs can occur.
- Importers must submit a self
- Declaration specifying the residual life of goods.
- U.S. companies should consider establishing local offices for service support and spare parts due to high demand for refurbished equipment.
- Recent initiatives aim to increase domestic production and reduce dependency on imports.
IndonesiaNo importation of used and refurbished medical equipment is allowed.
Iran- 0% to 20% depending on the device category.
- Specific tariff rates should be confirmed with the Iranian.
- Customs Administration or the relevant HS codes.
- A license from the Bureau of Industry and Security (BIS) is required for most items on the Commerce Control List (CCL).
- OFAC authorization is necessary for exports to Iraq.
- The Iranian Food and Drug Administration (IFDA) oversees medical device imports. Registration involves:
- Appointing a local representative
- Using the IMED system for registration
- Classifying the device by risk
- Assessing compliance with technical standards
- Reviewing documentation for safety and performance.
- Appoint a representative in Iran to manage the import process.
- Submit an electronic request through IMED, complete required documentation, and undergo compliance assessments.
Iraq15%- Registration of the foreign supplier at the Ministry of Health (MOH) Registration Board.
- For each consignment to the private sector, documents must be presented before an import license is issued by the MO 510(k) Number.
- Medical equipment must adhere to Iraqi standards enforced by the Central Organization for Standards and Quality Control (COSQC)
- Marking requirements such as country of origin and date of manufacture/expiration
- Local chamber of commerce stamp
- State Secretary of State, Department of State authentication,
- Stamp from the Iraqi Commercial Attaché in Washington, D.C.
- Bill of lading
- KIMADIA, the government company responsible for public health sector imports, operates a tender procurement system.
- Understanding KIMADIA's processes and having a local representative can be advantageous.
- Corruption is a significant issue
- With 31 CFR Chapter five lifted and the institution of section 576, open exchange with Iraq has become legal.
Israel- Most tariffs between the U.S. and Israel have been eliminated under the U.S. Israel FTA.
- Duties are generally zero for medical devices.
License is required.- All medical devices must be registered with the Medical Device Division (AMAR) of the Ministry of Health.
- Approvals such as FDA’s 510(k), CE Mark, or others from recognized countries are necessary for registration.
- Register a legal entity in Israel.
- Submit import licenses and technical specifications.
- Customs classification is key; consult a customs broker for assistance. Pre
- Ruling classification requests can be made to Customs.
JapanTypically, 0% to 4.6%- An import permit is required after declaring the goods to the Director
- General of Customs.
- Used medical equipment must comply with the Pharmaceuticals and Medical Devices Act (PMD Act).
- Customs evaluates the product's suitability for import, ensuring it meets safety and compliance standards set by Japanese regulations.
- Certain used medical equipment may require additional regulatory approvals based on health regulations, specifically from the Ministry of Health, Labor, and Welfare (MHLW).
- Required documents include the Import Declaration Form, commercial invoice, and packing list.
- The consumption tax of 10% (standard rate) or 8% (reduced rate) is calculated on the customs value plus any customs duty.
JordanNo importation of used and refurbished medical equipment is allowed.
Kazakhstan- Average tariff rate is 6.1% (as of 2020).
- 0% on certain medical equipment.
Importers must obtain a license for medical equipment.- Compliance with EAEU Technical Regulations is necessary for imported medical products.
- Certain items (e.g., hazardous materials) are prohibited.
- Full customs declaration required within 30 days: brief declaration within 24 hours after the crossing of the border.
- Customs declaration must be filed by local entities only.
- ATA Carnets can be used for temporary, duty
- Free imports for exhibitions and trade fairs.
- A certificate of conformity may be required.
- Import of used medical equipment is subject to additional scrutiny.
- A traceability system is in place for medical products; serialization required by 2023.
- Importers may need to adhere to specific labeling guidelines for medical devices.
- All products must be labeled in Kazakh and Russian.
Kuwait- Medical items, including used medical equipment, may qualify for duty
- Free status if they meet certain criteria
- Import licenses are required from the Ministry of Commerce and Industry, valid for one year (renewable).
- Registration with the Kuwait Chamber of Commerce and Industry (KCCI) is necessary.
- Local agents handle customs clearance.
Compliance with international standard.- Commercial invoice, certificate of origin, packing list, and bill of lading.
- Customs valuation follows the WTO Customs Valuation Agreement, primarily using transaction value.
U.s. companies should work with local partners to navigate registration and import processes effectively.
KyrgyzstanIt depends on the classification.- Importers must obtain state registration from the Ministry of Health.
- Registration involves submitting an application, dossier, samples, paying a fee, and passing safety and quality checks.
- The process typically takes 4
- 5 months but should not exceed 90 days.
- The registration certificate is valid permanently; no renewal is needed.
- A foreign manufacturer needs an authorized representative in Kyrgyzstan.
- Governed by the EAEU Customs Code (Articles 8, 89, 108).
- Products must have labeling in Russian and/or Kyrgyz.
- Standard customs, clearance and control procedures per EAEU Customs Code.
- Official translation of documents into Russian may be required.
Lao People's Democratic RepublicNo importation of used and refurbished medical equipment is allowed.
LebanonNo importation of used and refurbished medical equipment is allowed.
Malaysia- Simple average applied tariff of 6.1% for industrial goods.
- Sales and Services Tax (SST) applies at 5% or 10% on taxable goods.
Specific permits and licenses are required for the importation of used medical equipment.- Importation of used medical equipment is allowed; however, the public healthcare sector does not procure used equipment.
- Compliance with SIRIM QAS certification may be necessary.
- Required documentation includes: invoice, packing list, delivery letter, insurance certificate, Bill of Lading/Airway Bill, and Customs Form No. 1.
- Duties and taxes must be paid in advance.
- Demand for used medical equipment comes primarily from small healthcare practitioners.
- Malaysia follows the Harmonized Tariff System for classification.
MongoliaSpecific tariff rates may vary based on the type of equipment.- An import license must be obtained to carry out the import of medical devices.
- Diagnostic medical devices are subject to additional registration requirements.
- The procedures for issuing licenses are governed by Health Minister’s Order No.
- A/407 (November 1, 2017)
- Applicants must provide a range of documents, including agreements with suppliers and certification of compliance with international standards.
- Diagnostic medical devices must be registered according to Order of the Ministry of Health No.
- 13 (January 15, 2015).
- The issuance of licenses is regulated under various laws, including the Law on Medicines and Medical Devices.
- Dossier preparation for registration must adhere to national specific requirements.
- Applications for licenses must be submitted electronically, including detailed information on the imported products.
- The Center for Health Development monitors and reports on imports and exports quarterly.
- License applications are reviewed within five working days, and license holders are responsible for the accuracy of submitted information.
Myanmar- Tariffs vary based on the type of medical equipment classified under the ASEAN Medical Device Directive (AMDD).
- Import license fees range from MMK 250 to MMK 50,000 based on CIF value, with commercial tax varying from 5% to over 25% depending on the goods.
- Register as a company authorized for international trade.
- Obtain Importer Registration Certificate (valid for up to five years; fee: MMK 200,000 + MMK 3,000 online).
- Amendment of certificates: MMK 300 per entry.
- Extension of registration must be applied prior to expiry.
- Medical device registration through Myanmar FDA is mandatory.
- Compliance with ISO 13485:2016 required.
- Registration is classified by risk (Class A to D).
- FDA recommendation is needed for importing medical devices and cosmetics.
- Import restricted for certain goods without approval.
- Required documents: Authorization letter, free sale certificate, manufacturing license, ISO certificate, etc.
- Registration with the Directorate of Trade is necessary for import business.
- Customs duty and commercial tax collected at the point of entry.
Nepal- Import tariffs typically ranging from 0% to 80%.
- Medical equipment may be eligible for special duty reductions
- No import license required for used medical equipment.
- Must show general export/import permits and taxpayer’s certificate.
- If imported directly, provide corporate registration certificate and taxpayer’s certificate for customs clearance.
- Must comply with standards set by the Nepal Bureau of Standards and Metrology (NBSM) and the Department of Drug Administration.
- No special labeling required, but packaging must indicate country of origin.
- Commercial Invoice Customs Declaration Form (CDF)
- Certificate of Origin Packing List
- Airway Bill Authorization Letter (for exported items)
- Copy of Export License (if applicable)
- Foreign Exchange Declaration Form
- Photocopy of Income Tax Registration Certificate
- Letter of Credit or Advance Payment Statement
Oman- Tariffs not exceeding 10% on foreign, non American/GCC goods.
- U.S. origin products enjoy duty
- Free access under the U.S.
- Oman Free Trade Agreement (FTA).
- Tariffs on remaining products phased out in 2019.
- Registration of medical devices is not yet implemented; guidelines are still in draft form.
- Medical devices must be listed in the Medical Device Control Department databases.
- Oman harmonizes standards with the GCC through the Gulf Standards Organization (GSO).
- The Directorate General of Specifications and Metrology (DGSM) oversees standardization and conformity assessment.
- The Bayan system facilitates efficient customs clearance.
- Required documents include commercial invoice, bill of lading/airway bill, and relevant permits.
Pakistan- Customs duties levied on an ad valorem basis.
- 17% sales tax on the duty paid value.
- Importers must obtain authorization from the Drug Regulatory Authority of Pakistan (DRAP) before importing medical devices.
- Radioactive equipment requires approval from the Pakistan Nuclear Regulatory Authority
Used medical equipment must comply with standards set by drap and the pakistan standards and quality control authority (psqca).- Bills of lading invoices
- Packing lists certificates of origin
- Letters of credit insurance certificates.
Qatar5% tariff on the c.i.f. invoice value applies.Import licenses are required, issued only to qatari nationals or qatari partners, registered with the ministry of commerce and industry.- Submission of customs declaration
- Bill of lading, certificate of origin, pro forma invoice, and import license is necessary.
- Goods are subject to inspection at customs.
The hs code and country of origin must be clearly marked
Saudi ArabiaA common external tariff of at least 5% applies to most imported goods- An importation license is required.
- For medical devices intended for demonstration or training purposes, specific documentation must be submitted, including a classification certificate and declaration of conformity.
- Used medical equipment must conform to Saudi standards.
- Devices for demo/training purposes do not require Medical Device Marketing Authorization but must include labels indicating their intended use.
- Importers must complete “Fasah” platform procedures by submitting necessary documents and a customs declaration at least 48 hours before arrival.
- Required documents include a commercial invoice, bill of lading, and certificate of origin.
- For demonstration devices, additional documents like an attestation and labeling must be provided.
Only saudi nationals may import goods for resale, but foreign entities may trade their manufactured products.
Singapore- Refurbished medical equipment generally falls under the MFN zero
- Duty rate for nearly all tariff lines.
- U.S. exports to Singapore under the FTA are duty free.
- Special import licenses are required for medical devices.
- Compliance with specific regulations by the Health Sciences Authority (HSA) is mandatory.
- Importation of used and refurbished medical equipment is permitted but must meet the regulatory requirements based on Global Harmonization Task Force (GHTF) recommendations.
- Recognized independent reference agencies include the USFDA, EU, Health Canada, TGA, and Japan MHLW.
- Compliance with Singapore’s Good Laboratory Practice (GLP) regulations may apply depending on the equipment type.
- Products may need to be tested and certified to ensure they meet local requirements.
- Inward declaration is required for all imported refurbished medical equipment.
- Customs value is based on CIF and transaction value.
There is currently limited or no demand for used medical equipment in singapore.
South KoreaDuty freeOnly licensed importers certified by mfds can importUsed equipment requires 100% inspection at the importer’s facility.- Import declaration, invoice, certificate of origin
- Safety, performance, intended use, MoA documents
- The market for used medical equipment is limited. Non
- Registered devices can be imported for research, testing, or personal use under special conditions.
Sri Lanka10%- Must appoint a local authorized representative for registration and compliance
- Import license application required post registration
- Medical devices must meet stringent standards for chemical, physical, and biological properties.
- Infection risk minimization and safety in construction and environment are mandatory.
- Compliance with measurement accuracy and radiation protection standards is essential.
- Energy source reliability must be ensured for devices with energy connections.
- Submit certified shipping documents and customs declaration forms to the Sri Lanka Department of Customs.
- Original documents required within 30 days for clearance for goods shipped under DP/DA terms.
- For advanced payment (AP), submit proof of payment
SyriaPotentially exceeding 20% due to the strict regulations.- A license is required to export/reexport items subject to EAR to Syria, except for food or medicine designated as EAR99.
- Medical devices on the Commerce Control List (CCL) require a license; reviewed case by
- Case.
- General policy of denial for exports/reexports to Syria of EAR items.
- License exceptions may apply; detailed in Section 746.9 of the EAR.
- Medical devices and medicine on CCL reviewed individually.
- Compliance with local customs regulations is necessary.
- All shipments may be subject to inspection.
- Specific documents required for licensing and compliance with EAR must be prepared for customs clearance.
Tajikistan0% to15%- A permit is required from the State Health and Social Protection Service.
- Medical equipment must be registered with the state.
- Registration includes submitting an application, a registration file, and samples (5 copies).
- Certificate of conformity allows the use of a conformity mark.
- Governed by the Law of the Republic of Tajikistan “On Medicines and Pharmaceutical Activities” and Decree No. 736.
- Product labels must be in Tajik and Russian, including names, manufacturer, origin, production date, validity, storage, nutrition data, and usage instructions.
- Importer’s certificate of registration
- Taxpayer identification number
- Customs Cargo Declaration (in English)
- Additional documents may include contracts, shipping documents, and various certificates depending on the product type.
Import process can be complex; actual procedures may differ from posted regulations.
ThailandNo importation of used and refurbished medical equipment is allowed.
TurkmenistanAround 2%- A registration certificate from the State Registration Center for Medicinal Products of the Ministry of Health is required.
- A comprehensive registration dossier is required.
- Registration dossiers must include detailed documents confirming legal status, production conditions, compliance with national/international standards, and safety/efficacy.
- The registration process includes submission, review, and issuance of a certificate valid for 5 years.
- Contract registered at SCRME: Must specify goods, origin, currency, item price, and total price.
- Bill of Lading/CMR: Required for transportation verification.
- Certificate of Origin and Quality: Obtain from Turkmenistan Chamber of Commerce and Turkmen Standards.
- Customs Declaration: Buyer usually responsible; service fee of 0.2% of contract price.
- Additional licenses may be needed based on product type (e.g., alcohol, electronics).
- Any changes to registered medical devices must be submitted within 30 days of approval; approval may take 1 to 3 months. Re
- Registration is required 3 months before expiration of the current certificate and takes 3 to 4 months.
United Arab Emirates5%- Companies must have a trade license from the Department of Economic Development (DED).
- Medical equipment must be registered with the Ministry of Health and Prevention (MOHAP).
- Importers can establish their own legal entity or appoint a registered local agent for distribution.
- Each medical device must be classified and registered with MOHAP.
- Classification fee: AED 500; registration fee: AED 5,100 per product.
- Compliance with local laws, including health and safety regulations.
- Labeling must meet specific requirements, including language and content.
- Submit original documentation: commercial invoice, certificate of origin, packing list, import permit (if applicable), and bill of entry.
- Certain goods require additional health and safety certificates (e.g., health certificates for food products).
- Legalization of documents is required through the UAE Embassy.
Uzbekistan5% to 70%Mandatory registration with the ministry of health.- Registration overseen by the Ministry of Health.
- Devices classified into four categories (Class I, IIa, IIb, III) based on risk.
- Compliance with ISO 13485 standards is required.
- Registration timeline is 6 to 12 months, with a five year validity.
- Pre shipment inspections may be advisable to ease customs clearance.
Customs clearances can be conducted at various locations upon request.
Vietnam5%- Import license required for companies with a legal business entity in Vietnam.
- Medical devices must register for marketing authorization (MA) licenses.
- Strict regulations on used and refurbished medical equipment as per Decision 2019/1997/QD
- BKHCNMT, which requires inspection and certification by the Ministry of Technology and Science.
- Governed by Decree 169, effective December 2020, which outlines management of medical equipment.
- Compliance with licensing and registration requirements is mandatory for customs clearance.
- Imports of used medical equipment are subject to specific inspections and certifications.
Yemen5% to 20%- Importers must have valid licenses.
- Public health institutions purchase through a tendering system.
- Equipment must not be more than 8 years old.
- Used equipment must be in good condition
- Goods must be cleared within 15 days from submission of the Single Administrative Document (SAD).
- Goods left uncleared for 90 days may be auctioned.
- Additional documents may be required

Asia

 

Afghanistan

https://ticaret.gov.tr/data/5ee87d7713b87603d40acbd2/Ek-1%20Afganistan%20%C4%B0thalat%20Rehberi.pdf

https://ofac.treasury.gov/faqs/topic/8126

https://www.remotemedical.com/how-to-license-and-ship-medical-equipment-to-the-middle-east/

https://www.wto.org/english/thewto_e/acc_e/afg_e/wtaccafg5a1_leg_21.pdf

 

Armenia

https://cratia.ua/en/country/armenia/#:~:text=The%20import%2C%20sale%20and%20use,authorized%20without%20a%20state%20registration.

https://www.trade.gov/country-commercial-guides/armenia-import-requirements-and-documentation

https://www.dialog.am/storage/files/posts/posts_3585843838172_2022_pharma___medical_device_regulation_Armenia.pdf

 

Azerbaijan

https://cratia.com/en/news/registration-of-medical-devices-in-azerbaijan-starting-july-2024/#:~:text=State%20registration%20procedure%20for%20medical,Azerbaijani%20language%20are%20also%20required.

https://cratia.ua/en/country/azerbaijan/#:~:text=Azerbaijan%27s%20legislative%20requirements%20for%20importation,takes%20about%201%2D1.5%20months.

https://deltaswiss.eu/delta-medical-azerbaijan/medical-device-registrations-azerbaijan/#:~:text=Required%20Documents%20for%20Import%20and,required%20by%20the%20customs%20authorities

https://www.trade.gov/country-commercial-guides/azerbaijan-trade-barriers

 

Bahrain

https://www.nhra.bh/AR/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/guidelines/MDR_Guideline_Medical%20Devices%20Regulation_2019.pdf

 

Bangladesh

https://www.trade.gov/country-commercial-guides/bangladesh-customs-regulations

https://mavenprofserv.com/medical-devices-registration-in-bangladesh/

https://www.regdesk.co/classification-guidelines-for-medical-devices-in-bangladesh/

 

Bhutan

https://dra.gov.bt/?p=3393

https://www.mof.gov.bt/wp-content/uploads/2018/01/CRRB2017.pdf

https://tecex.com/countries/import-into-bhutan/

 

Brunei Darussalam

https://www.trade.gov/country-commercial-guides/brunei-import-requirements-and-documentation

https://www.aseanbriefing.com/news/import-and-export-procedures-in-brunei-best-practices/

 

Cambodia

https://www.trade.gov/country-commercial-guides/cambodia-pharmaceuticals-medical-supplies-and-medical-equipment

https://andamanmed.com/cambodia-medical-device-regulation/

 

China

https://iamers.org/2015/05/pre-owned-medical-importation-by-country/

 

Georgia

https://www.trade.gov/healthcare-resource-guide-georgia

https://deltaswiss.eu/delta-medical-georgia/medical-device-registrations-georgia/

https://www.trade.gov/country-commercial-guides/georgia-import-requirements-and-documentation

 

India

https://www.trade.gov/country-commercial-guides/india-healthcare-and-life-science#:~:text=However%2C%20the%20import%20of%20used,disputes%20with%20Indian%20customs%20authorities.

https://www.trade.gov/knowledge-product/india-trade-barriers?navcard=2957

https://legalmetrologyindia.com/blog/general-license-legal-metrology/#:~:text=What%20is%20the%20open%20General,forbidden%2C%20and%20freely%20importable%20goods.

 

Indonesia

https://www.trade.gov/country-commercial-guides/indonesia-healthcare-medical-devices-equipment

https://www.trade.gov/country-commercial-guides/indonesia-prohibited-and-restricted-imports#:~:text=The%20regulation%20provides%20new%20categories,and%20toxic%20materials%2C%20among%20others.

https://iamers.org/2015/05/pre-owned-medical-importation-by-country/

 

Iran

https://eec.eaeunion.org/upload/medialibrary/649/Guidance-on-the-Islamic-Republic-of-Iran-Trade-Regulation-2020.pdf

https://www.bis.doc.gov/index.php/policy-guidance/country-guidance/sanctioned-destinations/iran

 

Iraq

https://www.bis.doc.gov/index.php/policy-guidance/country-guidance/iraq

https://www.bis.gov/ear/title-15/subtitle-b/chapter-vii/subchapter-c/part-746/ss-7463-iraq

https://www.remotemedical.com/how-to-license-and-ship-medical-equipment-to-the-middle-east/

https://www.trade.gov/country-commercial-guides/iraq-health-care-medical-equipment-supplies

 

Japan

https://www.j-mdc.com/en/import/index.php#:~:text=Medical%20devices%20that%20are%20not,or%20lend%20unapproved%20medical%20devices.

https://www.trade.gov/country-commercial-guides/japan-prohibited-restricted-imports\

 

Jordan

https://www.trade.gov/country-commercial-guides/jordan-healthcare#:~:text=In%202019%2C%20the%20Ministry%20of,for%20all%20imported%20medical%20devices.

 

Kazakstan

https://www.trade.gov/country-commercial-guides/kazakhstan-import-requirements-and-documentation

https://www.wto.org/english/thewto_e/acc_e/kaz_e/wtacckaz77a1_leg_4.pdf

https://www.regdesk.co/kazakhstan-new-importation-exportation-rules/

 

Kuwait

https://iamers.org/2015/05/pre-owned-medical-importation-by-country/#:~:text=Kuwait%3A%20No%20importation%20of%20used%20and%20refurbished%20medical%20equipment%20is%20allowed.

https://www.trade.gov/country-commercial-guides/kuwait-import-requirements-and-documentation

 

Kyrgistan

https://www.trade.gov/country-commercial-guides/kyrgyz-republic-licensing-requirements

https://mspcorporate.com/state-registration-of-medical-devices-kyrgyzstan.html#:~:text=The%20national%20registration%20procedure%20is,issuance%20of%20the%20Registration%20Certificate.

 

Laos

https://www.laotradeportal.gov.la/en-gb/search-procedure/view/38#:~:text=%2D%20Certificate%20of%20ISO%2013485%20from,are%20not%20allowed%20to%20import

 

Lebanon

https://www.trade.gov/country-commercial-guides/lebanon-prohibited-restricted-imports

 

Malaysia

https://www.trade.gov/country-commercial-guides/malaysia-trade-agreements

 

Mongolia

http://www.hdc.gov.mn/media/files/english-import,%20export%20407.doc#:~:text=1.9.,6.

https://cratia.com/en/countries/mongoliya/registracziya-mediczinskih-izdelij/#:~:text=Special%20food%20products%20and%20cosmetics:&text=Medical%20devices%20and%20medical%20equipment,ua%2C%20or%20visit%20our%20office.

 

Myanmar

http://www.myanmarembassy.sg/commercial/myanmar-trade-rules/

https://credevo.com/articles/2022/11/25/medical-device-registration-process-in-myanmar/#:~:text=Medical%20device%20registration%20is%20a,you%20need%20an%20FDA%20recommendation.

https://www.myanmartradeportal.gov.mm/guide-to-import#:~:text=1.,Exporter/Importer%20Registration%20Certificate%20here.

 

Nepal

https://www.trade.gov/country-commercial-guides/nepal-standards-trade

 

Oman

https://www.trade.gov/country-commercial-guides/oman-licensing-requirements-professional-services

https://www.regdesk.co/resource-library/oman/#:~:text=Registration%20of%20Medical%20Devices%20in,medical%20device%20control%20department%20databases.

 

Pakistan

https://www.trade.gov/country-commercial-guides/pakistan-healthcare-and-medical-equipment#:~:text=The%20Government%20of%20Pakistan%20imposes,Pakistan%20Nuclear%20Regulatory%20Authority%20approval.

https://iamers.org/2015/05/pre-owned-medical-importation-by-country/

https://www.regdesk.co/resource-library/pakistan/

 

Qatar

https://www.trade.gov/country-commercial-guides/qatar-trade-agreements

 

Saudi Arabia

https://www.regdesk.co/sfda-importation-requirements-of-devices-for-demonstrations/

https://www.trade.gov/country-commercial-guides/saudi-arabia-import-tariffs

 

Singapore

https://iamers.org/2015/05/pre-owned-medical-importation-by-country/#:~:text=Singapore%3A%20Importation%20of%20used%20and,Harmonization%20Task%20Force%20(GHTF).

https://www.trade.gov/country-commercial-guides/singapore-trade-agreements

chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.hsa.gov.sg/docs/default-source/default-document-library/summaryoffeedbackreceivedfromthepublicconsulationontheproposedhealthproductsmedicaldevicesregulations_2aug07.pdf

 

South Korea

https://iamers.org/2015/05/pre-owned-medical-importation-by-country/#:~:text=Korea%3A%20Importation%20of%20used%20and,for%20a%20new%20medical%20equipment.

https://www.trade.gov/country-commercial-guides/south-korea-medical-equipment-and-devices

 

Sri Lanka

https://www.trade.gov/country-commercial-guides/sri-lanka-trade-agreements

https://mavenprofserv.com/medical-devices-registration-in-sri-lanka/

 

Syria

https://www.bis.gov/articles/syria-export-controls

 

Tajikistan

https://www.trade.gov/country-commercial-guides/tajikistan-trade-agreements

https://beawire.com/2022/09/12/registration-of-medical-devices-in-tajikistan/

 

Thailand

https://iamers.org/2015/05/pre-owned-medical-importation-by-country/#:~:text=Thailand%3A%20No%20importation%20of%20used%20and%20refurbished%20medical%20equipment%20is%20allowed.

https://www.trade.gov/country-commercial-guides/thailand-prohibited-and-restricted-imports#:~:text=Thailand%20%2D%20Prohibited%20and%20Restricted%20Imports&text=Imports%20of%20used%20motorcycles%20and,from%20the%20Thai%20Customs%20website%20.

 

Turkmenistan

https://www.trade.gov/country-commercial-guides/turkmenistan-standards-trade

https://app.croneri.co.uk/countries/turkmenistan

https://deltaswiss.eu/delta-medical-turkmenistan/medical-device-registration-turkmenistan/

 

UAE

https://www.trade.gov/country-commercial-guides/united-arab-emirates-trade-agreements

https://www.propartnergroup.com/blog/2023/01/import-sell-medical-devices-uae/#:~:text=In%20order%20to%20import%20and,Development%20(DED)%20Trade%20Licence.

https://www.regdesk.co/resource-library/uae/

 

Uzbekistan

https://www.trade.gov/country-commercial-guides/uzbekistan-trade-agreements

https://operonstrategist.com/uzbekistan-medical-device-registration/

 

Vietnam

https://www.trade.gov/market-intelligence/vietnam-medical-device-registration-0

https://www.viettonkinconsulting.com/general/how-to-import-medical-goods-into-vietnam/

https://andamanmed.com/market-access-services/importation-services/vietnam/#:~:text=In%20order%20to%20import%20a,simply%20obtain%20a%20product%20license.

https://www.vietnam-briefing.com/news/vietnams-medical-devices-industry-key-market-entry-considerations.html/#:~:text=Requirements%20and%20registration%20process,medical%20device%20to%20the%20market.

https://www.artixio.com/post/vietnam-regulations-for-registration-of-medical-device#:~:text=In%20Vietnam%2C%20manufacturers%20and%20importers,verify%20adherence%20to%20the%20regulations.

 

Yemen

https://arazygroup.com/ivd-medical-device-registration-yemen/

https://ofac.treasury.gov/media/932621/download?inline

Click on a Region to see a country’s requirements

Want to See ALL of the Countries Requirements?

Let’s Discuss Your Needs

Because we carry equipment from all of the leading medical equipment manufacturers and are “vendor neutral,” we can help you find the equipment solution that best meets your needs.

Back To Top