• Head Office: Unit 502, 5th floor, No. 222, Kashani Ave, Tehran
  • Working Hours: Sat to wed, 8.30 AM - 5 PM (Tehran Time)
  • Phone

    +989121536145

Contact Us

Dialysis machine filter clearance

  • Home
  • Dialysis machine filter clearance
Customs clearance of dialysis machine filter | HS 90189090, documents, IMED permit, and clearance steps

Customs Clearance of Dialysis Machine Filter from Iran Customs (HS Code + Documents and Permits)

Customs clearance of dialysis machine filter The dialysis filter (Dialysis Filter) is one of the most important and sensitive components used in the medical field, especially in the treatment of kidney failure. As the core part of the dialysis machine, these filters play a vital role in purifying the blood of patients who, due to renal problems, cannot perform this natural body function. Using these filters, the dialysis machine removes waste substances, toxins, and excess fluids from the blood and returns the purified blood to the patient’s body, thereby simulating the function that the kidneys perform in the body.

For an accurate estimate of time and cost for clearing dialysis machine filters and coordinating Ministry of Health permits, contact the experts at Saba Tarkhis.

Immediate & Free Consultation

1) Importance and Applications of Dialysis Filters in Medicine

Dialysis filters are key components of the hemodialysis process, one of the most effective and widely used treatments for patients with chronic kidney failure. In this method, the patient’s blood is removed from the body and enters the dialysis machine, where the dialysis filter performs purification. The dialysis filter has a semipermeable membrane that allows waste materials and excess fluids to pass from the blood while larger molecules such as proteins and blood cells, which are essential for the body, remain in the blood. This purification process is not only vital for kidney patients but is also used in emergencies such as acute poisonings.

2) Challenges and Key Points in Clearing Dialysis Filters from Customs

Customs clearance of dialysis filters, due to the high sensitivity of this commodity and its importance in safeguarding patient health, requires specialized knowledge and awareness of precise laws and regulations. This process is complex and meticulous because of multiple technical and regulatory aspects and requires attention to key points discussed below.

3) Customs Tariff and HS Code

Dialysis filters, based on the international classification of goods, fall under tariff code 90189090. This code relates to medical and surgical equipment, and accurately determining this code during customs clearance is highly important, since any error in classification can lead to legal issues and delays in clearance. The customs tariff directly affects import costs; therefore, precise knowledge of current tariffs and how they are calculated is essential.

4) Quality Standards and Regulatory Compliance

One of the major challenges in clearing dialysis filters is ensuring compliance with international standards such as ISO and CE. These standards guarantee that filters are of high quality and safe for use in medical devices. Customs and regulatory bodies carefully review these standards, and any non-conformity may result in the shipment being returned or even heavy fines. Therefore, suppliers and importers must ensure full compliance of their goods with these standards.

5) Storage and Transportation Conditions

Due to the high sensitivity of dialysis filters, their storage and transport conditions must be carefully controlled. These goods usually require specific temperature and humidity controls to prevent any degradation of quality and performance. Failure to observe these conditions can damage the filters, which not only entails financial loss but may also endanger patient health. Therefore, choosing reputable carriers and using warehouses equipped with temperature and humidity control systems is essential.

6) Major Exporting and Importing Countries of Dialysis Filters

Dialysis filters are mainly imported into Iran from advanced countries such as Germany, the United States, Japan, and Switzerland. Given their technological advances and production of high-quality medical equipment, these countries are among the leading manufacturers of such devices. Imports of these goods into Iran increase annually due to the growing need for modern, advanced medical equipment. Conversely, exports of these filters from Iran to neighboring countries such as Iraq and Afghanistan are also expanding, as Iran plays an important role as a major regional supplier of medical equipment to these countries.

7) Volume of Imports and Exports of Dialysis Filters in Iran

Imports of dialysis filters into Iran have been on an upward trend due to the increasing need for these vital medical devices and the rapid growth of hospitals and treatment centers. According to recent statistics, thousands of units of these filters are imported into Iran annually. These imports are highly significant due to the high quality of filters produced in developed countries. On the other hand, Iran’s domestic production by improving quality and meeting international standards has gradually gained a foothold in regional export markets.

8) Best Practices for Clearing Dialysis Filters

Customs clearance of dialysis filters is a process that requires deep knowledge of customs laws and regulations as well as full awareness of the requirements and standards for medical devices. For this reason, working with professional and experienced customs brokers can help accelerate and facilitate this process. Such cooperation not only prevents potential problems but also minimizes clearance time and costs by leveraging their experience and expertise.

9) Essential Documents for Customs Clearance of Dialysis Filters: A Complete Guide

Customs clearance of dialysis filters is a complex and sensitive process that requires careful attention to the necessary documents and paperwork. These filters, which play a key role in treating patients with renal failure, due to their high importance in the medical field, require strict compliance with regulations and the submission of accurate, complete documentation.
1. Proforma Invoice
The proforma invoice (or quotation) is the initial document issued to provide details of the goods, sales terms, and estimated prices. This document serves as the basis for creating the official commercial invoice and determining the customs value. It must include complete and accurate information such as the seller’s and buyer’s names, detailed description of the goods, and estimated prices.

2. Commercial Invoice
The commercial invoice is the primary official document for determining the actual value of the goods. It should contain the following information:
Full names and addresses of the seller and buyer
Accurate description of the goods: here, the dialysis filter must be listed with all technical and application specifications.
Quantity, weight, and unit price of the goods
Total price: to be calculated accurately and presented transparently.
Payment and delivery terms: including details on trade terms and sales conditions.

3. Certificate of Origin (CO)
The Certificate of Origin is a document indicating the country in which the goods were manufactured. Issued by chambers of commerce or similar bodies, it helps determine customs tariffs and apply trade agreements. The CO must confirm the dialysis filter was produced in the specified country.

4. Order Registration
Order registration is a legal document that records purchase information in electronic systems. These records are used as official documentation in customs and trade processes and include precise purchase details required for control and tracking.

5. Required Permits from the Ministry of Health and the Medical Equipment Organization
Because dialysis filters are categorized as medical devices, obtaining the necessary permits from the Ministry of Health and the Medical Equipment Organization is essential. These include:
Medical device import permit: approval indicating the product is authorized for import into the country.
Device registration certificate: confirmation of registration and approval for the use of the new medical device.

6. Quality Certificate
The quality certificate confirms that the dialysis filter complies with international standards such as ISO and CE. Issued by manufacturers or accredited laboratories, it evidences the product’s conformity with global standards.

7. Customs Declaration Form (Green Sheet)
The customs declaration includes precise information about the goods, their value, and import/export details. It helps customs correctly calculate duties and taxes and accurately assess the goods.

8. Packing List
The packing list details the packaging of the goods, including the number of packages, weight of each package, and their dimensions. It helps customs ensure the shipment contents match the information provided in the commercial invoice during inspection.

9. Insurance Certificate
The insurance certificate shows that the goods are insured during transportation. It protects the shipment against potential damages during transit and confirms that coverage is in place.

10. Test Certificate
In some cases, dialysis filters require a test certificate confirming that the goods meet health and performance requirements and specific standards. This certificate is usually issued by accredited laboratories and guarantees the quality and safety of the goods.

11. Tariff Sheet
The tariff sheet includes information on the customs duty rates for imported goods. It helps determine customs costs and calculate import duties and taxes and must be prepared carefully based on current tariffs.

Proper and complete preparation and submission of these documents are the key to successful customs clearance of dialysis filters. Any deficiency or inconsistency can lead to clearance delays, additional costs, and legal issues. Working with specialized and experienced customs brokers can speed up clearance and reduce associated risks. With full knowledge of customs laws and practical experience in medical device clearance, such brokers can ensure all steps are performed correctly and in full compliance with regulations.
Goods Short Description HS Code
Dialysis Machine Filter (Dialyzer) Consumable medical device; semipermeable membrane 90189090

Final classification depends on dialyzer type (High/Low Flux), membrane materials, sterile/single-use status, and packaging.

Need precise HS Code determination, IMED permitting, and document preparation? Our team manages the entire file end-to-end.

Request a Proforma Quote

10) Key Points and Practical Recommendations

  • Before shipment, verify brand/model registration and permit in the medical device registry (IMED).
  • Strictly observe medical labeling requirements (Lot/Serial, manufacturing/expiry dates, storage conditions) on unit/carton.
  • Include cold-chain/temperature control conditions and responsibilities in the purchase contract.
  • CE/ISO 13485 certificates and membrane performance test reports should be attached to the file.
  • For hospital urgency, opt for air/express transport and the specialized medical equipment clearance channel.

Frequently Asked Questions

What is the HS Code for a dialysis filter?

Generally classified under 90189090; final determination depends on membrane type, use, and packaging specifications.

What permits are required for import?

Brand registration/permit in IMED (Food & Drug Organization), order registration with the Ministry of Industry, plus CE and quality standards such as ISO 13485 along with CO/CI/PL and other carriage documents.

What are the storage and transport conditions?

Temperature/humidity control per manufacturer’s instructions, avoid freezing/overheating, standard warehousing, and transport with experienced medical-device carriers.

How long does clearance take and how much does it cost?

It varies based on document completeness, shipment type, transport mode, and entry customs; with a complete file, faster clearance at specialized customs is feasible.

Multimedia Suggestions

  • Image file name: dialysis-filter-customs-clearance-iran.jpg
  • Alt Text: Customs clearance of dialysis machine filter in Iran | HS 90189090 | IMED permit
  • Caption: “Dialyzer clearance steps; from HS to CE/ISO standards”
  • Infographic: “Dialyzer clearance document checklist & temperature/humidity control”

Suggested Links

Summary and Call to Action

Clearing dialysis filters given their medical nature, strict standards, and regulatory requirements demands careful planning, complete documentation, and coordination with the Ministry of Health. Saba Tarkhis, with hands-on experience in medical-device files, advances your process quickly and in full compliance with regulations.

Request Expert Consultation Get a Clearance Proforma

Saba Brokerage’s Specialized Services for Dialysis Filter Clearance

In the complex and sensitive process of clearing dialysis filters, having a reputable and experienced partner can make a significant difference. Leveraging experience and expertise in medical-device clearance, we offer specialized services that help you manage the process efficiently and with peace of mind. These services are as follows:

Specialized Consulting: Our experts review documents and conditions related to dialysis filters and provide the best clearance solutions. This consulting includes needs analysis, customs regulation assessment, and proposing optimized strategies to facilitate the process.

Handling All Administrative Steps: All required administrative steps for clearing dialysis filters from order registration to obtaining permits from the Ministry of Health and related authorities—are handled completely and accurately by our team. This includes preparing and completing documents, registering information, and conducting all necessary follow-ups at every stage.

Continuous Follow-up: Through ongoing and up-to-date tracking, we ensure precise timing for goods clearance. Potential issues at various stages are identified and resolved quickly so the process proceeds smoothly and without disruption.

Transport and Warehousing: We ensure your dialysis filters are transported and stored under the best conditions. We pay special attention to proper logistics and warehousing to prevent any potential damage to product quality and make sure the filters arrive correctly and safely at their destination.

Quality and Speed Assurance: With extensive experience in medical-device clearance, we guarantee the high quality and speed of our services. Our ability to manage processes effectively and quickly reduces both costs and the time required for clearance.

Contact our experts for more information.

Back to Index

Powered by