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Customs Clearance of Surgical Sutures in Iran (HS Code + Documents & Permits)
Customs clearance of surgical sutures Surgical sutures are among the vital and specialized tools in medicine and surgery, playing a key role in wound closure and tissue repair after operations. These sutures are used to close internal and external wounds, prevent infection, and accelerate the healing process of damaged tissues. Given that surgical sutures must meet high quality and international standards, importing and clearing these products through customs requires specialized steps and strict compliance with relevant laws and regulations.
To estimate the time and cost of surgical sutures clearance and obtain Ministry of Health/IMED permits, contact Saba Tarkhis experts.
Instant & Free Consultation1) Types of Surgical Sutures & Their Uses
Surgical sutures are broadly classified into two categories: absorbable and non-absorbable. Each category is used for specific surgeries based on different clinical needs:
Absorbable Sutures: These sutures are naturally or chemically absorbed by the body after a defined period, eliminating the need for removal once the wound has healed. They are commonly used in internal surgeries and in procedures where access to the stitches is difficult. Polyglactin (Vicryl) and catgut are among the most well-known absorbable sutures.
Non-Absorbable Sutures: These sutures must be removed by the surgeon after wound healing and are used where more durable closure is required. Nylon, polypropylene, and silk are examples, commonly used in cardiac, dermatologic, and plastic surgeries.
2) Steps & Requirements for Customs Clearance of Surgical Sutures
Due to the sensitivity of these products and the need to comply with international standards, clearing surgical sutures through customs requires following specific steps and meeting certain requirements. Some of the most important stages and requirements are:
Obtaining health and medical device permits from the Ministry of Health: The first and most important step for importing and clearing surgical sutures is obtaining the necessary permits from the Ministry of Health. These permits indicate the product’s compliance with national health standards and ensure its safety in surgical use. Failure to obtain these permits can prevent clearance and create legal issues for the importer.
International standards: Surgical sutures must comply with international medical device standards such as ISO 13485 and CE Marking. These standards ensure quality and safety; non-compliance may lead to legal and technical challenges during importation.
3) Customs Tariff (HS Code) for Surgical Sutures
The customs tariff or HS Code is a critical matter in clearing surgical sutures. The tariff codes for absorbable and non-absorbable sutures are as follows:
- HS Code 30061010: Absorbable surgical sutures
- HS Code 30061090: Non-absorbable surgical sutures
Correct HS classification early in the process is crucial; misclassification can cause unnecessary costs or legal issues during clearance.
4) Special Conditions for Import & Export of Surgical Sutures
As essential and sensitive medical items, surgical sutures play a very important role in clinical procedures. Import is vital due to the growing need for high-quality, advanced medical equipment and ongoing medical progress worldwide. This section reviews import/export conditions, Iran’s import/export volumes, and best clearance practices.
Import of Surgical Sutures into Iran
Countries such as Germany, the United States, China, South Korea, and India are major exporters of surgical sutures to Iran. With advanced technology and trusted global approvals such as CE Marking and FDA Approval, these countries supply a large portion of sutures worldwide. Due to high demand among hospitals, clinics, and surgical centers for quality, standard products, imports to Iran are consistently large. Import growth is driven by expansion in healthcare and the rising number of general and specialized surgeries. Imported sutures, compliant with international standards, are used even in complex procedures.
Export of Surgical Sutures from Iran
In recent years, Iran has managed to export some domestically produced medical devices to regional markets. Iraq, Afghanistan, and several Central Asian countries are among the destinations for Iranian surgical sutures. However, due to high domestic demand and limited production capacity, a significant portion of Iran’s needs is still met through imports, so exports remain relatively limited.
5) Import & Export Volume of Surgical Sutures to Iran
Iran’s import volume of surgical sutures has grown notably year over year. Owing to continuous healthcare development and the rapid rise of specialized and general surgeries, Iran is one of the largest importers in the Middle East. Imports especially for public/private hospitals and specialized surgical centers—are widespread. In recent years, demand growth from hospitals and complex surgeries has further increased import volumes. According to Iran Customs reports, millions of dollars are spent annually on importing surgical sutures.
6) Global Surgical Sutures Market
The global market for surgical sutures is one of the fastest-growing segments in medical devices, driven by rising demand in both developing and developed countries. Reports indicate a substantial increase in global market value in recent years. Germany, the United States, and China are leading producers and exporters, holding a significant share. Asian and European countries, due to increasing surgeries and advances in medical technology, are major consumers.
Top Global Exporters of Surgical Sutures
Germany: With advanced technology and high product quality, Germany is a top producer and exporter. German companies such as Ethicon and B. Braun are globally renowned. United States: With giants like Johnson & Johnson and Medtronic, the U.S. is among the leading producers, supplying a large portion of global demand. China: Thanks to large-scale manufacturing and competitive pricing, China is a key player. India and South Korea: Both have made significant advances in medical devices and are notable exporters.
Major Global Importers of Surgical Sutures
Countries such as Iran, Brazil, Mexico, and Indonesia are among the largest importers. Rapid population growth, expanding hospital networks, and the need for advanced medical equipment drive high import volumes.
7) Required Documents for Customs Clearance of Surgical Sutures
Clearing surgical sutures through customs—given their sensitive medical use—requires specific documentation. As essential operating-room consumables, sutures must be imported in line with international standards. Importers must submit accurate and complete paperwork to ensure a smooth clearance process.
Invoice
The commercial invoice is a primary document containing seller/buyer details, product type, price, and terms. It must be prepared accurately to verify that the goods match the purchase specifications.
Packing List
The packing list details how the goods are packed, including number of packages, weight per package, and packaging type. It is essential for physical inspection and must align with the invoice.
Bill of Lading (B/L)
The bill of lading confirms shipment from origin to destination. Issued by the carrier, it includes mode of transport, consignor/consignee names, and carriage terms, and must match other documents.
Certificate of Origin (CO)
The CO shows where the goods were manufactured and is issued by the origin country’s chamber of commerce. It is mandatory for verifying the origin in customs.
Health Certificate
Given their clinical use, sutures require a health certificate, confirming compliance with global sanitary standards and safe use in surgery.
Medical Equipment Registration Certificate
Issued by Iran’s Ministry of Health, this confirms that sutures are registered as medical devices and have market entry permission. It is mandatory for clearance.
Import Permit from the Ministry of Health
As sensitive medical goods, sutures require an import permit from the Ministry of Health, ensuring compliance with Iran’s health and safety standards.
Certificates of Compliance with International Standards
Sutures must comply with ISO 13485 and CE Marking. Providing these certificates demonstrates quality and safety and is required for final customs approval.
Customs Release Permit
After submission and approval of all documents, customs issues the release permit, allowing the importer to take delivery and ship to the final destination.
Invoice
The commercial invoice is a primary document containing seller/buyer details, product type, price, and terms. It must be prepared accurately to verify that the goods match the purchase specifications.
Packing List
The packing list details how the goods are packed, including number of packages, weight per package, and packaging type. It is essential for physical inspection and must align with the invoice.
Bill of Lading (B/L)
The bill of lading confirms shipment from origin to destination. Issued by the carrier, it includes mode of transport, consignor/consignee names, and carriage terms, and must match other documents.
Certificate of Origin (CO)
The CO shows where the goods were manufactured and is issued by the origin country’s chamber of commerce. It is mandatory for verifying the origin in customs.
Health Certificate
Given their clinical use, sutures require a health certificate, confirming compliance with global sanitary standards and safe use in surgery.
Medical Equipment Registration Certificate
Issued by Iran’s Ministry of Health, this confirms that sutures are registered as medical devices and have market entry permission. It is mandatory for clearance.
Import Permit from the Ministry of Health
As sensitive medical goods, sutures require an import permit from the Ministry of Health, ensuring compliance with Iran’s health and safety standards.
Certificates of Compliance with International Standards
Sutures must comply with ISO 13485 and CE Marking. Providing these certificates demonstrates quality and safety and is required for final customs approval.
Customs Release Permit
After submission and approval of all documents, customs issues the release permit, allowing the importer to take delivery and ship to the final destination.
| Goods | Short Description | HS Code |
|---|---|---|
| Absorbable Surgical Sutures | Medical consumable; absorbable | 30061010 |
| Non-Absorbable Surgical Sutures | Medical consumable; non-absorbable | 30061090 |
Final classification depends on suture material (Vicryl/Nylon/PP/Silk), size, sterile/non-sterile, surgical application, and packaging.
Need accurate HS coding, IMED permits, and document preparation? Our team manages your case end-to-end.
Request a Proforma Quote8) Best Practices for Clearing Surgical Sutures
Customs clearance of sutures requires deep knowledge of customs rules and full awareness of medical device requirements and standards. Partnering with experienced customs brokers speeds and simplifies the process, prevents potential issues, and minimizes clearance time and cost.
9) Key Tips & Practical Recommendations
- Verify brand/model registration and permits in the IMED (medical devices) system before shipment.
- Ensure complete medical labeling (Lot/Serial, size, MFG/EXP dates, storage conditions) on unit and carton.
- Attach CE and ISO 13485 certificates and, if possible, strength/biocompatibility test reports to the file.
- For urgent hospital needs, consider air/express shipping and specialized medical-device clearance lanes.
Frequently Asked Questions
What is the HS Code for surgical sutures?
Typically 30061010 for absorbable sutures and 30061090 for non-absorbable sutures; final determination depends on specifications and packaging.
Which permits are required for import?
IMED (Food & Drug Organization) brand registration/permit, Ministry of Industry order registration, CE and ISO 13485 certificates, and shipping documents (CO/CI/PL/BL).
What are the time and cost to clear?
They vary by document completeness, suture type, shipping mode, shipment volume, and entry customs; with a complete file, faster clearance at specialized customs is possible.
Media Suggestions
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surgical-sutures-customs-clearance-iran.jpg - Alt Text: Customs clearance of surgical sutures in Iran | HS 30061010 & 30061090 | IMED Permit
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Wrap-Up & Call to Action
Clearing surgical sutures due to their medical nature, strict standards, and regulatory requirements demands careful planning, complete documentation, and coordination with the Ministry of Health. Saba Tarkhis leverages hands-on experience with medical-device files to move your process quickly and compliantly.
Request Expert Consultation Get a Clearance ProformaSaba Brokerage’s Specialized Services for Suture Clearance
With years of experience clearing medical devices including surgical suturesSaba Brokerage offers specialized services to importers of these products. Key services include:
Specialized documentation consulting: Our professional team helps importers prepare all documents required for suture clearance completely and accurately.
Fast tracking of health permits: In close coordination with the Ministry of Health, we secure the necessary health permits quickly and precisely.
Accurate tariff classification & filing: With full knowledge of customs law and related tariff codes, we select the optimal HS classification to avoid extra costs.
Expedited clearance: Leveraging our network and experience, we complete suture clearance in the shortest possible time while complying with all legal steps.
These professional services ensure your sutures are cleared quickly and without issues and delivered to their final destination.
