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Customs clearance of IV infusion sets | HS Code, documents, permits & health requirements

IV Infusion Set Customs Clearance in Iran (HS Code + Documents & Permits)

IV infusion set customs clearance  As one of the most essential medical supplies in clinics and hospitals, infusion sets play a vital role in patient care. They are widely used to administer fluids, medicines, and nutrients intravenously. Because of the product’s high sensitivity and direct impact on patient health, importing and clearing it from customs requires accuracy and strict compliance with legal and health regulations.

To estimate the time and cost of IV infusion set clearance, contact Saba Tarkhis experts.

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1) What is an IV infusion set?

An IV infusion set is a medical device made up of several components: high-grade plastic tubing that carries fluids into the patient’s body, a drip chamber that plays a key role in controlling the infusion rate, stainless-steel needles to access the patient’s vein, and flow regulators that allow clinicians to precisely adjust the rate. Materials commonly used include PVC (polyvinyl chloride) or polyethylene, chosen for their contamination resistance and flexibility.

2) Importance and requirements for clearing IV infusion sets

Importing IV infusion sets into Iran comes with a set of legal requirements and challenges that must be carefully addressed to avoid delays or customs penalties. Given the sensitive nature of these devices and their role in protecting and improving patient health, the following points are especially important:
Obtaining the necessary permits: One of the most important steps is securing approvals from competent authorities such as the Iran Ministry of Health’s Medical Devices Directorate. These permits confirm the product complies with national health and safety standards. Without them, clearance may be denied and the shipment may even be returned.
International standards: Imported infusion sets should hold valid certifications such as ISO 13485 for medical-device quality management. CE (Conformité Européenne) marking  evidencing compliance with EU safety, health, and environmental protection requirements  is another key prerequisite. Such standards both assure quality and satisfy legal conditions for import and market placement.
Quality control: QC is a core stage of the clearance process. Typically, samples are sent to accredited laboratories to verify product quality and safety. Tests aim to ensure freedom from technical defects, microbial contamination, and that medical standards are met. This prevents substandard or hazardous products from entering the market and builds trust among buyers and end users.
Packaging and labeling: Packaging must protect the sets from damage and contamination during transit. Labels must include complete and accurate details: manufacturer, production and expiry dates, serial/Lot number, storage conditions, and required warnings. These details are essential for customs/health compliance and for informing clinicians and end users. Poor packaging or incomplete labels can lead to rejection at customs or legal issues.

3) HS tariff for IV infusion sets

As a rule, IV infusion sets fall under HS 90183900, covering medical appliances and injecting devices. The exact duty rate and import costs depend on factors such as country of origin, trade relations between Iran and the exporting country, and contract terms. Preferential tariffs or special reductions may apply under certain agreements. For instance, imports from China or India may benefit from lower duties depending on specific arrangements, helping reduce overall import costs and ultimately patient treatment costs.
Goods Short description HS Code
IV infusion set Tubing, drip chamber, needle, flow regulator 90183900

Final classification depends on material, single-use/sterile status, packaging, and accessories (needle/cannula).

4) Exporting and importing countries

Major global producers/exporters of infusion sets include China, India, South Korea, Germany, and Italy, leveraging advanced technologies and international standards to supply high-quality products worldwide. Iran, while meeting domestic demand, has also pursued localized production and selective exports to neighboring and African markets. Iraq, Afghanistan, Syria, and other regional countries are common destinations for Iranian products.

5) Import and export volumes

Imports of infusion sets into Iran are significant due to high demand from hospitals and clinics. Exact volumes vary with sanctions, FX fluctuations, and domestic needs. Globally, trade in infusion sets as part of the wider medical-device market  has grown steadily, driven by expanding healthcare services and infrastructure improvements in developing countries.

6) Best practices for faster clearance

Choose a customs broker experienced in medical devices to manage the administrative and legal workflow and prevent delays. Using online customs systems for filing and tracking documents can also shorten clearance time.

Need precise HS classification, MoH (Medical Devices Directorate) permits, and document prep? Our team manages the entire file end to end.

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7) Required documents for clearing IV infusion sets

Clearing infusion sets requires several documents, each essential for verifying product quality and legality. Details include:
1. Proforma Invoice
Description: Item details such as set specifications, quantities, unit price, total price, payment terms, and shipping method.
Role: Basis for customs calculations and obtaining initial permits.

2. Commercial Invoice
Description: Final supplier-confirmed invoice mirroring proforma details.
Role: Used for payment and assessing duties and taxes.

3. Packing List
Description: Full packaging information (carton count, gross/net weight, dimensions).
Role: For reconciling shipment contents and facilitating inspection.

4. Certificate of Origin
Description: Identifies the producing country, usually issued by the exporter’s chamber of commerce.
Role: Determines tariff treatment and eligibility for preferences.

5. Import permit from the Medical Devices Directorate
Description: MoH authorization to import infusion sets.
Role: A core legal prerequisite without which clearance is not possible.

6. International certificates (e.g., ISO 13485 and CE Marking)
Description: Demonstrate compliance with international standards.
Role: Support quality/safety assurance and legal market access.

7. Inspection Certificate
Description: Issued by an independent inspection body confirming conformity with the PO/specs.
Role: Sometimes required pre-shipment and at customs.

8. Bill of Lading / Air Waybill
Description: Transport document issued by the carrier; evidence of title and shipment details.
Role: Required to release goods.

9. Customs Declaration
Description: Full import data submitted by the importer/representative.
Role: Basis for assessing duties/taxes and clearance.

10. Delivery Order
Description: Issued by the carrier after all freight/terminal charges are settled.
Role: Used to collect cargo from the customs warehouse.

11. Health permit / Iran FDA confirmation
Description: Required if sets contain specific materials/components.
Role: Ensures safety for patient use.

12. Cargo Insurance Policy
Description: Coverage against transit risks.
Role: Enables compensation if loss/damage occurs.

13. Business/Trade Card
Description: Import/export license issued by the Chamber of Commerce.
Role: Mandatory for all import/export activities and clearance.

14. International transport compliance certificate (if required)
Description: Confirms transport method complies with relevant international rules.
Role: Needed where shipments are governed by specific international regimes.

Submitting complete and accurate documentation accelerates clearance and prevents legal/administrative issues. A seasoned customs broker can prepare and file everything on time.

Frequently asked questions

What is the HS Code for infusion sets?

Typically 90183900; final classification depends on components, packaging, and technical documentation.

Which permits are mandatory to import infusion sets?

Approval from the Medical Devices Directorate (Ministry of Health), plus international certificates like ISO 13485 and CE as applicable.

How does customs quality control work?

Samples are tested by accredited labs for microbiology, sterility, and standard compliance; results directly affect clearance.

What must the label include?

Manufacturer name/address, mfg/expiry dates, Serial/Lot, storage conditions, warnings, and IFU. Incorrect labeling can lead to rejection.

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Wrap-up & call to action

Choose our brokerage for clearing infusion sets and other medical devices to benefit from professional, fast, and cost-effective services  ensuring safe, hassle-free imports with high product quality delivered in the shortest possible time.

Request expert consultation Get a pro forma quote

Saba brokerage’s special services for medical-goods clearance

With years of customs-clearance experience  especially in medical devices  our firm is one of Iran’s leading providers. Leveraging a skilled team, we offer tailored services for clearing infusion sets and other medical equipment. Highlights include:

Specialized consulting & full guidance: Our experts support you through every import and clearance step, advising on optimal import routes, tariff review, and lawful cost-saving options.

End-to-end administrative management: We handle all formalities  permits, documentation, order registration, and customs procedures  ensuring fast, trouble-free clearance and on-time delivery.

Quality control & inspection: In cooperation with accredited labs, we perform QC and inspections to guarantee safety and quality, preventing substandard goods from entering the market.

Transport & warehousing: Post-clearance, we arrange safe and speedy logistics, storage, and distribution to the final destination.

24/7 support: Our round-the-clock support ensures any query or issue is resolved quickly at any stage of import and clearance.

Contact our experts for more information.

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