.png)
C-Arm Device Customs Clearance (HS Code + Documents and Permits)
Customs clearance of the C-Arm device: the C-Arm is one of the most advanced medical imaging devices, widely used in various therapeutic and surgical fields including orthopedics, cardiovascular surgery, urology, general surgery, and specialized surgeries. Due to its exceptional ability to provide high-quality, real-time images of internal body structures, it has become an essential tool in operating rooms.
C-Arm devices generally use X-rays for imaging, allowing physicians to obtain high-resolution images of the treatment area. These features are especially critical during complex surgeries that require high precision. Since these devices are directly related to patient health, their customs clearance requires compliance with specific regulations and standards.
C-Arm devices generally use X-rays for imaging, allowing physicians to obtain high-resolution images of the treatment area. These features are especially critical during complex surgeries that require high precision. Since these devices are directly related to patient health, their customs clearance requires compliance with specific regulations and standards.
For estimating the time and cost of C-Arm Device Clearance, contact Saba Tarkhis experts.
Immediate Free Consultation1) Technical Specifications of C-Arm Device
C-Arm devices consist of two main parts:
X-ray Generator: Responsible for producing X-rays to create internal body images. It is located at the lower part of the device and usually includes advanced generators capable of producing powerful and precise X-rays.
Image Detector: Installed at the upper part of the device, it receives and converts X-rays into digital images. Thanks to the C-shaped design, detectors can rotate and capture images from various angles, making this feature essential for accurate and flexible imaging.
X-ray Generator: Responsible for producing X-rays to create internal body images. It is located at the lower part of the device and usually includes advanced generators capable of producing powerful and precise X-rays.
Image Detector: Installed at the upper part of the device, it receives and converts X-rays into digital images. Thanks to the C-shaped design, detectors can rotate and capture images from various angles, making this feature essential for accurate and flexible imaging.
2) Customs Tariff and HS Code for C-Arm Device
One of the most important steps in the customs clearance of the C-Arm device is determining the correct tariff and HS Code. The HS Code plays a key role in defining customs duties and directly affects import costs.
C-Arm devices are generally classified under HS Code 9022.12, which refers to radiology and fluoroscopy imaging equipment. Selecting the correct HS Code not only reduces extra costs but also speeds up clearance.
C-Arm devices are generally classified under HS Code 9022.12, which refers to radiology and fluoroscopy imaging equipment. Selecting the correct HS Code not only reduces extra costs but also speeds up clearance.
| Product | Short Description | HS Code |
|---|---|---|
| C-Arm Device | Fluoroscopy/Live Radiology in Operating Room | 9022.12 |
Final classification depends on technical specifications, power, accessories, and medical application.
3) Required Documents and Permits for C-Arm Clearance
Due to the sensitivity and complexity of C-Arm devices, their clearance requires multiple documents and permits ensuring quality and compliance with national and international standards. Key documents include:
Ministry of Health Permit: Confirms compliance with national and international standards. Given their critical medical use, C-Arm devices must meet strict safety and quality requirements under the Ministry’s supervision.
CE and FDA Certificates: CE indicates compliance with EU safety standards, while FDA approval confirms authorization for medical use in the USA. These globally recognized certificates are essential for import to Iran.
Order Registration & IRC Code: All imported medical devices must be registered in the official systems and issued a national IRC code to guarantee authenticity and quality. This is a key requirement for customs clearance.
Ministry of Health Permit: Confirms compliance with national and international standards. Given their critical medical use, C-Arm devices must meet strict safety and quality requirements under the Ministry’s supervision.
CE and FDA Certificates: CE indicates compliance with EU safety standards, while FDA approval confirms authorization for medical use in the USA. These globally recognized certificates are essential for import to Iran.
Order Registration & IRC Code: All imported medical devices must be registered in the official systems and issued a national IRC code to guarantee authenticity and quality. This is a key requirement for customs clearance.
4) Special Import Conditions for C-Arm in Iran
Import of C-Arm devices into Iran is subject to specific conditions. They must comply with international standards such as ISO 13485, IEC 60601, and CE. Compliance applies not only to manufacturing but also installation, commissioning, and after-sales service. Installation must be carried out by skilled technicians, and valid warranty and after-sales service are required. Without these, the device may not be licensed for use in medical centers.
5) Exporting, Importing Countries and Market Status
C-Arm devices are mainly imported to Iran from advanced countries such as Germany, Japan, the USA, and China. These countries are leading exporters thanks to their advanced medical technology. Major global manufacturers include Siemens, Philips, GE Healthcare, and Ziehm Imaging.
Conversely, Middle Eastern, African, and Asia-Pacific countries are key importers of these devices. Iran, with its growing demand for advanced medical equipment, is an important market.
With increasing demand, imports of C-Arm devices to Iran have grown significantly in recent years. Each year, a considerable number of units are imported for hospitals and clinics. However, economic constraints and currency fluctuations can present challenges for import.
Conversely, Middle Eastern, African, and Asia-Pacific countries are key importers of these devices. Iran, with its growing demand for advanced medical equipment, is an important market.
With increasing demand, imports of C-Arm devices to Iran have grown significantly in recent years. Each year, a considerable number of units are imported for hospitals and clinics. However, economic constraints and currency fluctuations can present challenges for import.
6) Documents Required for C-Arm Customs Clearance
Customs clearance of C-Arm devices requires a full set of documents proving compliance with medical and customs regulations:
- Ministry of Health Authorization: Import permit confirming compliance with health and safety standards, plus authorization for device entry after review of technical documents.
- International Standard Certificates: CE certificate (EU compliance), FDA approval (for US-origin devices).
- Order Registration & IRC: Device must be registered in Iran’s Trade System and issued an IRC (Iranian Registration Code).
- Commercial Invoice: Detailing price, quantity, technical specifications, buyer and seller info.
- Packing List: Full details on quantity, weight, dimensions, and packaging type.
- Certificate of Origin: Declares the manufacturing country, essential for tariffs and international trade compliance.
- Insurance Policy: Proof of shipping insurance covering risks during transport.
- Bill of Lading: Transport document showing shipment details and proof of ownership until delivery.
- Inspection Certificate: Confirms quality and safety, issued by an international or local inspection body.
- Release Order: Final customs authorization to release the device.
- Certificate of Conformity: Confirms compliance with Iranian national standards.
- Customs Declaration: Declares device value, HS code, and technical details.
- Non-Radiation Certificate: Confirms no radioactive contamination for radiation-related equipment.
- Health and Safety Certificate: Confirms safety of device for patients and operators.
Need HS Code consultation, Ministry of Health permits, or IRC code issuance? Our team manages the entire process from start to finish.
Request Proforma InvoiceFrequently Asked Questions
What is the HS Code for C-Arm?
Generally classified under 9022.12 (radiology/fluoroscopy). Final classification depends on technical specs and accessories.
Which permits are required for clearance?
Ministry of Health/Medical Devices Office authorization, order registration with IRC code, CE and, if applicable, FDA certificates, plus full commercial documents.
Is installation mandatory after clearance?
Yes; installation by skilled technicians, training, and provision of warranty/after-sales service are mandatory for medical center licensing.
What are the key documents for customs declaration?
Commercial invoice, packing list, bill of lading, certificate of origin, insurance policy, health permit, conformity/inspection certificate, and completed customs declaration.
Special Services by Saba Tarkhis
With years of experience in clearing medical equipment from customs, we provide specialized services for C-Arm clearance. Our expert team, fully familiar with customs laws and medical equipment regulations, ensures smooth and fast clearance of your C-Arm devices.
Our services include:
Expert Consultation: Providing technical and legal advice on correct HS Code selection and document preparation.
Permit Follow-up: Managing and obtaining required permits from the Ministry of Health and other relevant authorities.
Order Registration & IRC: Completing all order registration and IRC code issuance procedures to avoid clearance delays.
Fast Clearance: Leveraging expertise and networks to expedite the clearance process.
After-Clearance Services: Including installation, commissioning, warranty, and after-sales support for safe and optimal device operation.
With our proven expertise in medical device clearance, you can confidently complete all import and customs processes for your C-Arm devices quickly and successfully.
Our services include:
Expert Consultation: Providing technical and legal advice on correct HS Code selection and document preparation.
Permit Follow-up: Managing and obtaining required permits from the Ministry of Health and other relevant authorities.
Order Registration & IRC: Completing all order registration and IRC code issuance procedures to avoid clearance delays.
Fast Clearance: Leveraging expertise and networks to expedite the clearance process.
After-Clearance Services: Including installation, commissioning, warranty, and after-sales support for safe and optimal device operation.
With our proven expertise in medical device clearance, you can confidently complete all import and customs processes for your C-Arm devices quickly and successfully.
