Clearance of blood sugar testing device

Customs Clearance of Blood Glucose Meters in Iran (HS Code + Permits and Standards)

Introduction and Key Applications of Blood Glucose Meters

Importance of Importing and Clearing Blood Glucose Meters

1) HS Code and Customs Tariff

2) Technical and Professional Considerations in Clearance

1. HS Code and Tariff: Blood glucose meters fall under HS Code 9027.80.00 in the Harmonized System. This tariff covers devices used to measure or test medical parameters. Knowing this is vital for customs cost calculation and clearance procedures.
2. Import Permits: Since these are medical devices, importing them requires special permits from the Ministry of Health of Iran, including medical equipment import approval, compliance certificates, and safety/quality assurance documents.
3. Compliance with International Standards: Meters must comply with standards such as CE (Conformité Européenne) and ISO 13485 (quality management for medical devices). Compliance guarantees safety, quality, and accuracy.
4. Testing and Quality Review: Devices undergo inspection and quality tests by supervisory bodies to ensure conformity with national and international standards. Tests may include performance, electrical safety, and manufacturer specification checks.
5. Packaging and Labeling: Proper packaging and labeling in line with national standards are vital. Information such as expiry date, usage, storage, and serial number must be clearly shown.

3) Exporting and Importing Countries

4) Special Import Conditions and Import Volume to Iran

Final subheading depends on the model, included items (strips/lancets), and end use.

5) Required Documents for Clearance

1. Proforma Invoice — Issued by the seller before the transaction, detailing product specs, price, payment terms, and other deal conditions. Acts as the initial reference for confirming terms and clearance.
2. Commercial Invoice — A key document listing full product details, value, and shipping terms; submitted to customs for duty/tax calculation.
3. Packing List — Provides contents of each package including counts, net/gross weights, and dimensions; required for customs examination.
4. Bill of Lading or Air Waybill — Transport document issued by the carrier evidencing shipment from origin to destination; mandatory for clearance.
5. Certificate of Origin — Issued by the exporter’s chamber of commerce indicating where the goods were produced/assembled; may impact tariff preferences and reduce costs.
6. Medical Device Import Permit — Mandatory approvals from the Ministry of Health for quality, safety, and import authorization; clearance is not possible without these.
7. International Standards Certificates (CE and ISO 13485) — Evidence of compliance with essential quality, safety, and performance standards; must be presented to customs.
8. Health Certificate — In some cases, confirms conformity with health and safety requirements; issued by public health authorities and crucial for medical goods clearance.
9. Trade/Import Card — License issued by the Chamber of Commerce allowing entities to import/export; must be provided to customs.
10. Order Registration in the National Trade System — Records all purchase and product details prior to import; clearance is not permitted without it.
11. Delivery Order — Issued by the carrier upon arrival, authorizing the importer to take delivery; required to complete clearance steps.
12. Cargo Insurance Policy — Confirms insurance coverage during transport and ensures compensation in case of incidents.
13. Customs Declaration — Filed by the importer with accurate details of the goods, their value, and transport terms; basis for duty and tax assessment.
14. Pre-shipment Inspection Certificate — Confirms goods were examined before shipment per contract specs and standards; issued by accredited inspection companies.
15. Certificate of Conformity — Shows compliance with legal standards and national/international regulations; often required for medical device clearance.
16. Proof of Payment — Banking receipts/LC documents evidencing payment for goods and freight; submitted as part of the clearance file.
17. Operating License — If imported for commercial/industrial operation, the relevant operating license from competent authorities may be required.
18. Other Specific Permits/Approvals — Depending on the model and specs of the meters, additional permits from various bodies may be necessary; obtain them before import and present to customs.

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