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Customs Clearance of Medical Sterilization Devices, Surgical Tools, and Dental Autoclaves in Iran (HS Code + Documents and Permits)

Import and customs clearance of medical sterilization devices and dental autoclaves, due to the sensitive nature and hygienic importance of these devices, requires strict compliance with specialized laws and regulations. This complex process includes various steps, from selecting the correct customs tariff code (HS Code) to obtaining health permits and international standards.

For estimating the time and cost of clearing medical sterilization devices and autoclaves, contact Saba Tarkhis experts.

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1) Detailed Description of Medical Sterilization Devices and Dental Autoclaves

Medical sterilization devices refer to a set of machines and equipment used to eliminate pathogens such as bacteria, viruses, fungi, and spores. These devices are widely used in hospitals, dental clinics, surgical centers, and other healthcare environments. One of the most important devices is dental autoclaves. Autoclaves are machines that use high-pressure steam (about 121–134 °C) over specific times to completely sterilize medical and dental instruments. This sterilization process ensures the total elimination of pathogens and maintains hygiene in medical environments.

2) Importance and Specialized Applications

  • Maintaining hygiene in medical environments: Sterilization of medical and dental equipment using autoclaves significantly reduces the risk of infection transmission in hospitals and clinics. This is particularly vital in preventing hospital-acquired infections that can cause serious complications for patients.
  • Sterilizing surgical and dental instruments: Autoclaves are used to sterilize instruments that directly contact the patient’s body, such as surgical tools, forceps, dental mirrors, and other instruments. These must be completely sterilized before each use to minimize infection risks.
  • Use in medical and research laboratories: Sterilization of laboratory equipment with autoclaves is crucial for preserving accuracy and reliability in research results. Any contamination can distort results, making autoclave sterilization essential in labs.

3) Key Points in Clearance of Medical Sterilization Devices and Dental Autoclaves

  • Technical documents and certifications: To clear these devices from customs, providing technical documents including international standard certifications such as CE and Ministry of Health permits is mandatory.
  • Pre-clearance inspection: All imported devices must be reviewed for compliance with medical and hygienic standards. This includes qualitative and quantitative testing to ensure equipment safety.
  • Health certificate: Medical devices must have valid health certificates to confirm they pose no risk to users or patients.
  • Required permits: Importing these devices requires permits from the Ministry of Health and the Food and Drug Administration. These permits guarantee compliance with national standards.

4) Customs Tariff (HS Code)

Product/Group Short Description HS Code
General Medical Sterilization Devices Medical equipment subject to sterilization 9018.90.20
Dental/Thermal Autoclaves Thermal sterilization devices 8419.20

Correct determination of HS Code is crucial, as it directly affects customs costs and can either facilitate or complicate clearance. Consulting customs experts before importing is recommended to ensure accuracy.

5) Special Import and Export Conditions

Import

Medical sterilization equipment and dental autoclaves are imported under strict supervision of health authorities and precise customs regulations. Importers must provide the necessary documents and undergo inspections. Failure to comply can cause delays or even rejection of the shipment.

Export

For exporting these devices, international certifications and compliance with destination country standards are mandatory. Importing countries may impose specific requirements for medical devices that must be reviewed and met in advance.

6) Iranian Market

  • Iran is among the importers of these devices, and their import is carried out under strict health supervision.
  • To enter the Iranian market, Ministry of Health permits, CE and other certifications (if required) are mandatory.

7) Trade Volume: Iranian Imports and Global Turnover

Imports of these devices are strictly supervised, and any deficiency in documents or standards may cause delays. According to global statistics, the medical sterilization equipment market, especially related bandages/supplies, reaches several billion dollars annually.

8) Global Market

Main exporters: Leading countries in the medical device industry such as Germany, USA, Japan, and South Korea are among the top exporters.

Main importers: Developing countries as well as some developed ones such as Iran, India, Turkey, and Brazil are among the largest importers.

9) Required Documents for Clearance

  • Technical documents and international certifications (such as CE)
  • Permits from the Ministry of Health and Food and Drug Administration
  • Valid health certificate
  • Commercial and supplementary documents in accordance with customs regulations (as applicable)

Frequently Asked Questions

What is the HS Code for sterilization devices and autoclaves?

For general sterilization devices usually 9018.90.20 and for thermal sterilization devices (autoclaves) mainly 8419.20 are considered; final determination depends on technical specifications.

Which permits are required for clearance?

Permits from the Ministry of Health and Food and Drug Administration, health certificate, and international standard approvals such as CE.

Which countries are the main exporters and importers of these devices?

Germany, USA, Japan, and South Korea are main exporters; Iran, India, Turkey, and Brazil are major importers.

Multimedia Suggestions

  • Image file name: medical-sterilization-autoclave-customs-clearance-iran.jpg
  • Alt Text: Customs clearance of medical sterilization devices and dental autoclaves | HS 9018.90.20, 8419.20
  • Caption: «Clearance process of sterilization devices and autoclaves; from CE to Ministry of Health permit»
  • Infographic: «Checklist of permits, inspections, and HS Codes for sterilization devices»

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Conclusion and Call to Action

Saba Brokerage, with deep knowledge of customs regulations and familiarity with the latest updates in medical equipment import laws, ensures that your clearance process is handled professionally and smoothly. Your trust in Saba motivates us to provide the best clearance services for medical devices.

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Specialized Services of Saba Brokerage

With years of experience in clearing medical and healthcare equipment, especially sterilization devices and dental autoclaves, our brokerage is recognized as a leader in this field. Our specialized services include:

  • Expert consultation and HS Code selection: We choose the most appropriate HS Code for your goods based on their type and use, ensuring a fast and hassle-free clearance.
  • Preparation of required documents: Including international standard certifications (such as CE) and permits from the Ministry of Health and FDA, which are mandatory for clearance.
  • Follow-up on clearance stages: From the moment goods enter customs until delivery, we carefully monitor all clearance steps including inspections, qualitative and quantitative assessments, and submitting detailed reports to authorities.
  • Speeding up clearance: With our team’s expertise, your goods will be cleared as quickly as possible, reducing costs and delivery time.
  • Post-clearance services: We provide after-clearance services including consulting on equipment maintenance and usage, and guidance for re-export if needed.

Contact our experts for more information.

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