Customs Clearance for Hearing Aids in Iran

Hearing Aids Customs Clearance in Iran (HS Code + Documents & Permits)

Hearing aids customs clearance Hearing aids are vital devices for people with hearing impairment and play a significant role in improving their quality of life. These devices amplify and transmit sound waves to the ear, helping users hear better and face fewer challenges in social interactions and daily activities. Given their importance, importing and clearing hearing aids through Iranian customs requires precision and strict compliance with regulations.

For accurate estimates of the time and cost to clear hearing aids and to coordinate Ministry of Health permits, contact the Saba Tarkhis experts.

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1) Types of Hearing Aids & Their Uses

Hearing aids are categorized based on the type and severity of hearing loss and each person’s specific needs. They are generally divided into three main groups:

Behind-The-Ear (BTE): The most common type, worn behind the ear, suitable for various degrees of hearing loss. They offer high adjustability and more features than other types.

In-The-Ear (ITE): Placed in the outer ear; thanks to compact design and low visibility, they suit users seeking a discreet device.

Completely-In-Canal (CIC): The smallest style, sits entirely in the ear canal, designed for maximum discretion.

Additionally, cochlear implants are used for individuals with severe hearing loss. These devices require surgery and are recommended based on the degree of loss and each patient’s specific condition.

2) Hearing Aids Customs Clearance Process

Identify the HS Code: For any customs clearance, using the correct tariff code is mandatory. Hearing aids fall under HS Code 90214000 in the international classification system. This code covers both analog and digital hearing aids and must be used during clearance.

Prepare & Submit Required Documents: Clearing hearing aids requires a set of legal and health documents: Proforma Invoice, Commercial Invoice, Certificate of Origin, Order Registration, and Ministry of Health approval. International conformity certificates such as CE Mark or FDA are also essential to prove product quality and safety.

Comply with Health Regulations & International Standards: As medical devices, hearing aids must meet all relevant health and safety standards especially important for imports from countries with different regulations. Non-compliance can lead to rejection at customs and delays.

Sanctions Compliance & Import Controls: If importing from sanctioned countries, special permits and strict adherence to sanction rules are mandatory. These approvals from competent bodies can complicate and lengthen clearance.

Accurate Scheduling: Time management is critical. Due to market needs, fast clearance is important; any delay may cause supply shortages and increased final costs.

3) Import & Export Conditions in Iran

Imports: Iran mainly imports hearing aids from Europe and the United States. Germany, Denmark, Switzerland, and the USA are leading global producers/exporters. Due to the lack of domestic production meeting international standards, Iran relies on imports. Annual imports are estimated at around 100,000 to 200,000 units.

Exports: Exports from Iran are very limited, primarily due to insufficient quality and standards in this field.

4) Special Conditions for Import & Export

Importing Hearing Aids to Iran: Given their sensitivity, imports are controlled and supervised by the Ministry of Health. As medical equipment, they require strict international standards and domestic approvals.

Exporting from Iran: Exports are limited since domestic production lags technologically behind advanced countries, though in some cases assembled devices or parts are exported to neighboring markets.

5) Required Documents for Hearing Aids Clearance

To clear hearing aids through customs, prepare and submit a complete and accurate set of legal and health documents to the relevant authorities for a smooth process.
1. Proforma Invoice:
As the preliminary quotation, it includes full device specs, price, payment terms, shipping terms, and seller/buyer details. Used for order registration with the Ministry of Industry, Mine & Trade (MIMT).

2. Commercial Invoice:
The final invoice with exact device specifications, quantity, unit/total price, payment terms, and seller/buyer details. Crucial for clearance.

3. Certificate of Origin:
Issued by the Chamber of Commerce or a competent authority in the country of origin; required for tariff determination and compliance.

4. Order Registration Form:
Issued by MIMT indicating the import is officially authorized; prepared before import and includes item specs, value, and other details.

5. Ministry of Health (FDA Iran) Clearance Permit:
Since hearing aids are medical devices, permits from the Ministry of Health/Food & Drug Administration (IMED) are required; includes necessary approvals and quality checks.

6. International Conformity Certificates:
Devices should have CE Mark and/or FDA clearance, evidencing compliance with international health and safety standards.

7. Transport Insurance Policy:
Covers risks during transit; must include insurance conditions, transport mode, and insured value.

8. Packing List:
Details of packaging: number of packages, net/gross weight, dimensions, and contents used for customs checks and document matching.

9. Customs Declaration:
Provides complete information on goods, value, tariffs, freight costs, and related details; submitted by the importer or customs broker.

10. Special Permits (if applicable):
Required when importing from sanctioned countries or where special authorizations apply.

11. Bill of Lading:
Indicates the shipment from origin to destination and includes carrier, consignor/consignee, and cargo details necessary for clearance.

12. Pre-Shipment Inspection (if required):
In some cases, goods must be inspected before dispatch by an accredited inspection company to confirm contractual compliance.
Preparing all documents accurately speeds up hearing aid clearance. With hands-on experience in medical and healthcare products, Saba Brokerage can help compile these documents and manage a professional, hassle-free clearance process.

Item	Short Description	HS Code
Hearing aid (Analog/Digital)	Assistive medical hearing device	90214000

Final classification depends on model (BTE/ITE/CIC), features, power source, and accessories.

Need precise HS coding, Ministry of Health permits, and document preparation? Our team manages your case end-to-end.

Request a Proforma Quote

6) Key Tips & Practical Recommendations

Ensure technical pre-alignment with the General Office of Medical Equipment (IMED); brand/model must be on the approved list.
For large consignments, apply medical labeling standards (serial number, mfg/expiry dates, storage conditions) on carton/unit.
Define warranty/after-sales terms and supply of consumables/batteries in the purchase contract.
For high-traffic points (Tehran, Bandar Abbas, Bazargan), use a shorter clearance path with complete paperwork and coordinated shipping.

7) Best Practices for Hearing Aids Clearance in Iran

For fast, efficient clearance, follow these steps:
Fully prepare the file (order registration, IMED permit, CE/FDA, CO, CI, PL), coordinate transport (air/express for urgency), choose a medical-equipment specialist broker, pay duties/VAT on time, and perform quality control at entry points.

Frequently Asked Questions

What is the HS Code for hearing aids?

Hearing aids are generally classified under 90214000; final classification depends on model features and accessories.

What permits are required for import?

As applicable: Ministry of Health/FDA Iran (IMED) permit, MIMT order registration, and CE/FDA certificates, plus CO, invoice, packing list, and B/L.

What are the cost and timeline for clearance?

They depend on shipment size, transport route, completeness of documents, and the entry airport/customs. With a complete file, faster clearance is possible (especially at specialized medical-equipment customs).

Is import from sanctioned countries possible?

If sanctions apply, you’ll need special permits and strict compliance. Carefully review origin, banking, and shipping documents.

Saba’s Specialized Brokerage Services for Hearing Aids Clearance

With years of experience and a skilled team in medical and healthcare product clearance, we provide comprehensive, specialized services for hearing aids clearance from customs. Services include:

Pre-clearance consulting: Experts fully versed in customs, legal, and health requirements advise on proper HS classification, document preparation, and process optimization.
Obtaining required permits & documents: Through close coordination with the relevant bodies, all necessary documents and permits are secured quickly and accurately to accelerate clearance and reduce delay costs.
Fast & optimized clearance: Leveraging experience and expertise, hearing aids are cleared swiftly and efficiently so your goods reach the market without delay and at minimal cost.
Sanctions compliance & special import conditions: If importing from sanctioned origins, we handle required special permits and ensure full legal compliance.
Transparent, periodic reporting: You’ll receive clear status reports on clearance progress, enabling timely planning.

These specialized services ensure a smooth, expedited process so you can confidently bring your products to market.

Contact our experts for more information.

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