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Medical Devices Customs Clearance in Iran (HS Code + Documents and Permits)
Clearing medical devices from customs is one of the most important processes in the supply chain of these sensitive and vital products. Because medical devices play a direct role in diagnosis and treatment, they are recognized as strategic health commodities; therefore, their import must be carried out with special care and in accordance with stringent domestic and international regulations. Along this path—from obtaining legal permits to paying customs duties and complying with international health and safety standards—every step must be executed precisely.
To estimate the time and cost of medical device customs clearance, contact Saba Tarkhis experts.
Instant Free Consultation1) Detailed Description of Medical Devices
“Medical devices” include a wide range of machines, instruments, and consumables used for prevention, diagnosis, monitoring, treatment, and rehabilitation. From advanced imaging systems such as MRI and CT-Scan, and X-ray and ultrasound systems, to operating room equipment, vital signs monitoring, ventilators, and dialysis machines—all fall under this group. A broad set of consumables (masks, gloves, syringes, IV sets, filters) and infection control equipment (sterilizers and autoclaves) also covers a major share of health system needs.
Given public health sensitivity, these goods typically require health permits, strict quality control, and system-based traceability and registration. In Iran, registration in the IMED system (Iran’s Medical Devices Directorate) and obtaining permits from the Ministry of Health are mandatory for most items. Moreover, many devices must hold international certificates such as CE or FDA, indicating compliance with performance and safety standards. Packaging, transportation, and storage must also prevent damage, contamination, or potential failure.
In the import process, correct HS classification is crucial for calculating duties and taxes, determining required permits, and applying trade policies. Imaging devices are mainly classified in chapters 9018 and 9022, consumables in chapters 40, 63, and 90, and sterilization/process equipment in chapter 84. Any misclassification can cause delays, valuation disputes, and even denial of clearance. Engaging experienced experts for document preparation, declaration, technical checks, and coordination with relevant authorities minimizes risks.
2) Types and Applications of Medical Devices
A) Diagnostic Equipment
This category includes devices used to diagnose diseases and assess patient condition. Key examples are MRI (magnetic resonance imaging), CT-Scan, ultrasound, and laboratory equipment. They help physicians accurately diagnose conditions and determine appropriate treatment plans.
B) Therapeutic Equipment
Devices such as surgical equipment, patient monitors, ventilators, and other hospital systems fall here. They are used directly in treatment processes. Ventilators for acute respiratory issues, defibrillators for cardiac patients, and patient monitors for real-time tracking are typical examples.
C) Preventive and Protective
These items help prevent disease and control infection transmission—e.g., medical masks, latex gloves, disposable syringes, and other consumables—especially critical during public health crises.
D) Rehabilitation
Wheelchairs, physiotherapy systems, prostheses and orthotics, and hearing aids are used to restore function and improve quality of life.
E) Laboratory, Dental, Ophthalmic, and Cardiovascular
Centrifuges, microscopes, bio-analyzers; dental chairs and dental radiography; optometry and ophthalmic surgical tools; catheters, stents, and blood pressure monitoring systems are frequently used subgroups.
3) Key Points in Medical Device Clearance
- Ministry of Health permit and IMED registration are prerequisites for clearance.
- Accurate HS Code determination for duties, taxes, and supervisory permits.
- Complete documentation: invoice, packing list, certificate of origin, bill of lading, insurance, CE/FDA and CoC certificates.
- Quality control, technical compliance, and matching serial/model with documents and registrations.
- Consider sanctions restrictions, brand/origin limits, and payment/settlement requirements.
4) Customs Tariff (HS Code) for Selected Medical Devices
| Group / Item | Short Description | HS Code |
|---|---|---|
| MRI | Magnetic resonance imaging | 9018.13 |
| Ultrasound | Medical ultrasound | 9018.12 |
| CT-Scan | Computed tomography | 9022.12 |
| X-ray | X-ray apparatus | 9022.13 |
| Surgical equipment | Instruments and accessories | 9018.90 |
| Dialysis machine | Hemodialysis / peritoneal | 9018.39 |
| Ventilator | Respiratory support device | 9019.20 |
| Cardiac defibrillator | Defibrillator | 9018.11 |
| Medical mask | Protective consumable | 6307.90 |
| Latex gloves | Disposable medical | 4015.11 |
| Medical syringe | Injection / sampling | 9018.31 |
| Sterilizer | Autoclave / sterilization system | 8419.20 |
| Wheelchair | Chair on wheels | 8713.10 |
| Physiotherapy | Clinic devices / tools | 9018.90 |
| Prostheses and orthotics | Joints / lenses / artificial parts | 9021.31 |
| Hearing aid | Hearing assistance device | 9021.40 |
| Optical microscope | Laboratory | 9011.10 |
| Bio analyzer | Biological sample analysis | 9027.30 |
| Glucometer | Blood glucose measurement | 9027.80 |
| Dental chair | With equipment | 9018.49 |
| Dental surgical tools | Manual / electric tools | 9018.49 |
| Dental radiography | Dental imaging | 9022.13 |
| Optometry / eye exam | Ophthalmic diagnostic equipment | 9018.50 |
| Medical/surgical lenses | Contact / intraocular lenses | 9001.30 |
| Blood pressure monitoring | Cardiovascular monitoring | 9018.90 |
| Cardiac stent | Vascular implant | 9021.90 |
| Cardio/vascular catheter | Disposable / sterile | 9018.39 |
Exact classification depends on model, year of manufacture, risk class, application, accessories, and packaging.
Need precise HS Code determination, IMED registration, and Ministry of Health permits? Our team manages the entire case end-to-end.
Request a Proforma Quote5) Special Conditions for Import and Export
- Imports of medical devices into Iran are under very strict oversight due to their importance for public health. These devices must be thoroughly examined to ensure required quality and safety. Key conditions and specific regulations include:
Compliance with international standards: All imported medical devices must hold valid international certifications such as CE (EU) or FDA (USA). These certify safety, quality, and performance. Devices lacking such approvals cannot be cleared.
Rigorous quality control: After entry, devices undergo strict QC. The Ministry of Health and the Customs Administration inspect for compliance and quality. Any deficiencies or non-compliance can block clearance or entry.
Sanctions and trade restrictions: Due to international sanctions, importing some devices may face limitations. Importers must ensure products are not on sanction lists (by country, brand, or item) and coordinate checks with relevant bodies.
6) Iran Market
As a major consumer of medical devices in the region, Iran significantly relies on imports. With population growth, expansion of healthcare centers, and rising demand for advanced medical technology, imports have increased notably. Iran sources from countries such as Germany, China, Japan, South Korea, the United States, and the Netherlands.
Annual imports are estimated at around 2.5 to 3 billion USD, including complex equipment like MRI, CT-Scan, and advanced surgical systems. In recent years, Iran has also exported some devices to neighboring countries such as Iraq, Afghanistan, and Gulf states, although export volumes are relatively smaller than imports.
Annual imports are estimated at around 2.5 to 3 billion USD, including complex equipment like MRI, CT-Scan, and advanced surgical systems. In recent years, Iran has also exported some devices to neighboring countries such as Iraq, Afghanistan, and Gulf states, although export volumes are relatively smaller than imports.
7) Trade Volume
Iran: Medical device imports are estimated at 2.5 to 3 billion USD per year (including imaging, surgical equipment, and specialized consumables).
Global: The market in 2023 was about 650 billion USD and is projected to reach around 850 billion USD by 2030.
8) Global Market: Major Exporters and Importers
- Major global exporters
Some leading exporting countries include:
United States: the largest producer and exporter, supplying advanced diagnostic, therapeutic, and surgical systems.
Germany: a leader in precision, high-end medical equipment with a key global role.
Japan: producer of high-quality devices leveraging cutting-edge technology.
China: rapid growth in production and exports, now a major supplier.
Major global importers
Large importers are mainly developing countries and those with expanding healthcare systems:
India: one of the largest importers, sourcing from developed countries.
Brazil: imports extensively to develop medical and research sectors.
Mexico and South Africa are also significant importers.
9) Required Documents for Customs Clearance
- To clear medical devices from customs, various documents are essential. They must be prepared accurately and completely for a fast, issue-free process.
1. Ministry of Health Permit
The primary and most important document is the official permit from the Medical Devices Directorate. Without it, clearance is not possible.
2. IMED Registration
All devices must be registered in the IMED system, designed for oversight and control of medical device imports.
3. Commercial Invoice
Includes device type, quantity, price, and technical specifications. It must be precise to avoid ambiguities.
4. Certificate of Origin
Indicates the exporting country and requires the chamber of commerce’s endorsement. It matters for tariff determination.
5. Packing List
Details number of packages, weights, and dimensions for accurate customs inspection.
6. Bill of Lading
Issued by the carrier, includes transport details (sea/air/land).
7. Certificate of Conformity (CoC)
Shows compliance with quality and safety standards—typically issued by accredited bodies and endorsed by the Ministry of Health.
8. International Certificates (CE and FDA)
Imported devices should hold valid CE/FDA certificates proving global-standard compliance.
9. Insurance Certificate
Confirms the shipment is insured during transport.
10. Customs Declaration
Includes full import details: device type, HS code, value, and origin country.
11. Health and Safety Certificate
Mandatory for some devices—especially consumables—to confirm hygienic and safety compliance.
12. Pre-Shipment Inspection (PSI)
May be required for high-sensitivity items; issued by reputable inspection bodies to confirm compliance before shipment.
FAQs
Is clearance possible without the Ministry of Health permit?
No. For most devices, the Ministry of Health permit and IMED registration are mandatory; without them, clearance will not proceed.
How do we determine the HS Code for a device?
Based on the nature, function, model, risk class, and accessories. Our experts review technical specs and issue the precise classification.
Which countries are Iran’s main suppliers?
Mainly Germany, China, Japan, South Korea, the United States, and the Netherlands. Export destinations include neighboring and Gulf countries.
How large is the global medical devices market?
The global value was about 650 billion USD in 2023 and is estimated to reach 850 billion USD by 2030.
Key Points and Practical Tips
- Before placing orders, finalize permit status, risk class, and CE/FDA standards.
- Device serial/model and configuration must match documents and IMED registration.
- For sensitive items, arrange PSI and robust anti-shock/moisture packaging.
Suggested Links
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- Infographic: “Clearance roadmap: from CE/FDA to hospital delivery”
Summary & Call to Action
Due to health requirements, CE/FDA standards, IMED registration, and technical sensitivity, medical device clearance requires precise management. With hands-on experience, Saba Tarkhis handles your case quickly, safely, and in full compliance.
Request Expert Consultation Get a Clearance ProformaSaba Brokerage’s Specialized Services in Medical Device Clearance
By offering comprehensive, specialized services, this brokerage manages all stages of importing and clearing medical devices from start to finish, ensuring quick, obstacle-free entry. Key services include:
Pre-import expert consulting: Professional advice from the outset through final clearance, fully aligned with laws and regulations.
Permit registration and follow-up: Handling all health permits from the Ministry of Health and IMED registration to avoid customs issues.
Full document management: Preparing and submitting invoices, packing lists, certificates of origin, insurance, etc., fully compliant with customs requirements.
Real-time clearance tracking: Monitoring every step from port of entry to final delivery to prevent delays.
Transport & insurance services: Partnering with reputable carriers and providing comprehensive insurance to ensure safe delivery.
By working with this brokerage, importers can be confident their device clearance will be handled quickly and professionally.
