The C-Arm device represents one of the most sophisticated medical imaging technologies extensively utilized across various medical and surgical disciplines, including orthopedics, cardiovascular surgery, urology, general surgery, and other specialized procedures. Due to its unparalleled capability in producing high-resolution, real-time images of internal anatomical structures, the C-Arm has become an indispensable tool in modern operating rooms.
C-Arm devices employ X-ray technology for imaging, allowing medical professionals to capture high-definition images of the target area. This capability is particularly vital during complex surgical interventions that demand exceptional precision. Given the direct implications for patient health, customs clearance of these devices necessitates strict adherence to specific regulatory and compliance standards.
Technical Specifications of the C-Arm Device
The C-Arm device is composed of two principal components:
X-ray Source: This unit is responsible for generating X-rays used to capture images of internal structures. Positioned at the lower end of the device, the X-ray source generally incorporates advanced generators capable of delivering high-power, precision-controlled radiation.
Image Detector: Positioned in the upper part of the device, the image detector converts X-rays into digital images. Owing to the C-shaped design, the detector can be maneuvered through multiple angles, enabling comprehensive visualization of the target area. This rotational and angular flexibility is one of the device's most critical features, allowing for enhanced accuracy and optimal visualization during medical procedures.
Customs Tariff and HS Code for C-Arm Devices
A pivotal step in the customs clearance of C-Arm devices is the accurate determination of the customs tariff and HS code. The Harmonized System (HS) Code plays a fundamental role in calculating customs duties, directly impacting the overall importation costs.
C-Arm devices are generally classified under tariff code 9022.12, which is specifically assigned to radiology and fluoroscopy imaging equipment. Correctly identifying the tariff code not only mitigates superfluous expenses but also expedites the clearance process. Hence, thorough knowledge of customs tariffs and the precise selection of the HS code is crucial for efficient importation.
Documents and Permits Required for C-Arm Device Clearance
The complexity and sensitivity inherent in the importation of C-Arm devices necessitate obtaining a range of permits and documents to ensure compliance with national and international quality standards. These documents serve to validate the device's safety, quality, and regulatory adherence. Key documents and permits required for customs clearance of C-Arm devices include:
Ministry of Health Permit: This permit certifies the quality and compliance of the device with both national and international standards. Given the critical application of C-Arm devices in clinical settings, they must conform to all safety and quality requirements, under the supervision of the Ministry of Health.
CE (Conformité Européenne) and FDA (Food and Drug Administration) Certificates: The CE certificate signifies conformity with European Union health and safety standards, while the FDA certificate denotes the device's approval by the U.S. Food and Drug Administration. These certifications are globally recognized and are prerequisites for importing the device into Iran. Their possession guarantees that the device has successfully undergone rigorous quality control measures, ensuring its suitability for use in healthcare facilities.
Order Registration and Obtaining IRC (Iranian Registration Code): All imported medical devices must be registered within pertinent systems, and a national IRC code must be issued. This registration process is pivotal in verifying the authenticity and quality of the imported goods, making it a critical requirement for C-Arm device clearance.
Special Conditions for Importing C-Arm Devices to Iran
Importing C-Arm devices into Iran is subject to stringent regulations and conditions. These devices must comply with international standards such as ISO 13485, IEC 60601, and CE certifications. Compliance with these standards is critical not only during the manufacturing stage but also throughout installation, commissioning, and subsequent after-sales service phases.
Post-clearance, the installation and commissioning of the device must be executed by experienced and qualified technicians. Additionally, providing a valid warranty and after-sales service is mandatory, as failure to meet these requirements may prevent the device from gaining approval for use in medical institutions.
Exporting and Importing Countries of C-Arm Devices
C-Arm devices are predominantly imported to Iran from technologically advanced countries such as Germany, Japan, the United States, and China. These nations are leaders in the production of medical imaging devices, with renowned manufacturers such as Siemens, Philips, GE Healthcare, and Ziehm Imaging being among the top suppliers of C-Arm units globally.
In contrast, major importing regions include the Middle East, parts of Africa, and several countries within the Asia-Pacific region. Iran, due to its increasing demand for advanced medical and therapeutic equipment, remains a significant market for these devices.
Import Volume of C-Arm Devices to Iran
In response to growing demands for advanced healthcare technology, the volume of C-Arm device imports to Iran has surged significantly over recent years. According to available data, a substantial number of these devices are imported annually to enhance the infrastructure of the nation's hospitals and healthcare facilities. Nonetheless, economic challenges and exchange rate volatility can present obstacles in the importation process.
Documents Required for Customs Clearance of C-Arm Devices
The customs clearance of C-Arm devices, owing to their technological complexity, mandates the submission of numerous documents to ensure regulatory compliance. These documents validate adherence to national and international standards as well as customs and health regulations.
1. Ministry of Health, Treatment, and Medical Education Permit:
Medical Equipment Import Approval: Issued by the Medical Equipment Department, this permit verifies that the imported device satisfies health and safety standards mandated by the country.
Goods Entry Permit: Issued following an evaluation of the device's technical documents and certificates, this permit is a critical step in the importation process.
2. International Standard Certificates:
CE Certificate (Conformité Européenne): Confirms compliance with EU standards concerning health, safety, and environmental safeguards.
FDA Certificate (Food and Drug Administration): Required for C-Arm devices imported from the U.S., this certificate ensures that the device meets standards for medical use in the U.S.
3. Order Registration and Receiving IRC:
Registration in the Comprehensive Trade System: The importer must register the device and obtain the necessary order registration code, which is vital for all subsequent customs clearance procedures.
Obtaining IRC (Iranian Registration Code): This code, issued by the Medical Equipment Department, signifies the legitimate registration of the device as an importable item.
4. Commercial Invoice:
Purchase Invoice: Should detail the price, quantity, technical specifications, and relevant information regarding both the seller and the buyer.
5. Packing List:
Packaging Details: Must include specific information on the number, weight, dimensions, and type of packaging to verify consistency with customs documentation.
6. Certificate of Origin:
Country of Manufacture: Indicates the country where the C-Arm device was produced, playing a role in determining customs duties and verifying compliance with international trade regulations.
7. Transport Insurance Policy:
Transport Insurance: Demonstrates coverage for any damage that may occur during transit, underscoring the importer’s responsibility to safeguard the device.
8. Bill of Lading:
Transport Document: Provides details regarding the transportation of the goods, serving as evidence of ownership until delivery to the importer.
9. Inspection Certificate:
Certificate of Goods Condition and Quality: Issued by an inspection authority, either international or domestic, certifying the condition and quality of the device.
10. Release Order:
Issuance of Release Permit: After all procedures and document approvals, customs will issue a release permit, authorizing the removal of the device.
11. Certificate of Conformity:
Compliance with Domestic Standards: Issued by the Iranian National Standards Organization or an accredited body, confirming that the device meets Iranian national standards.
12. Customs Declaration:
Goods Declaration to Customs: All relevant details, including the value, HS code, and technical characteristics, must be included in the customs declaration.
13. Non-Radiation Certificate:
Confirmation of No Radioactive Contamination: Required for medical devices involving radiation, verifying that there are no hazardous radioactive components.
14. Health and Safety Certificate:
Device Safety Approval: Certifies that the C-Arm device is safe for both operators and patients and complies with national health regulations.
Special Services of Sabā Customs Brokerage in C-Arm Device Clearance
With extensive experience in facilitating the customs clearance of medical devices, we provide specialized services for the clearance of C-Arm units. Our expert team, equipped with in-depth knowledge of customs regulations and the intricacies of medical equipment importation, assists clients in ensuring a smooth and efficient clearance process.
Our services include:
Specialized Consultation: Offering expert technical and legal guidance on selecting appropriate customs tariff codes and completing the necessary documentation to navigate the clearance process effectively.
Permits Follow-up: Coordinating and acquiring all requisite permits from the Ministry of Health and relevant authorities, thereby reducing delays and facilitating a seamless clearance process.
Order Registration and IRC Code Procurement: Managing all steps of the order registration process and obtaining the IRC code for medical equipment, ensuring compliance and preventing issues during subsequent stages.
Fast Clearance: Leveraging our expertise and extensive network, we expedite the customs clearance process, ensuring that clients receive their equipment in the shortest possible time.
Post-Clearance Services: Including installation, commissioning, and the provision of warranties and after-sales support to ensure optimal device performance within healthcare facilities.
With our expertise in customs brokerage and medical device clearance, you can confidently rely on our high-quality, efficient services to successfully manage every aspect of C-Arm device importation and clearance.
Contact our experts for more information.
