Humanitarian Access
We support the lawful supply of medical devices and consumables that contribute to healthcare delivery, in accordance with applicable humanitarian authorizations, exemptions, and regulatory requirements.
Market Access & Compliance
Compliance & Regulatory Framework for Medical Devices in Iran
Sinoohe Medical is committed to facilitating responsible, transparent, and compliant trade in medical devices and consumables for the Iranian healthcare market. We work with international manufacturers and suppliers to support a structured approach to product documentation, regulatory coordination, quality assurance, and cross-border trade.
This page provides an overview of our compliance principles, the general regulatory framework relevant to medical-device trade with Iran, and the documentation that can help prospective partners prepare for cooperation. It is intended as a practical reference for manufacturers and suppliers and does not replace independent legal, regulatory, export-control, or banking advice.
Our Approach
Our Compliance Principles
Our approach is built around responsible access to medical goods, appropriate due diligence, product quality, confidentiality, and clear supporting records.
Know Your Counterparty
We follow a risk-based due-diligence approach to suppliers, buyers, financial institutions, logistics providers, and other relevant parties. This includes appropriate screening against applicable sanctions and restricted-party lists, as well as verification of transaction details and intended end use.
Quality, Traceability & Patient Safety
We prioritize product quality, appropriate manufacturer quality-management documentation, batch traceability, product-safety monitoring, and relevant post-market processes. Depending on the product and applicable requirements, manufacturer documentation may include ISO 13485 and ISO 9001 certifications.
Confidentiality & Data Protection
We respect the confidentiality of technical, commercial, and regulatory information exchanged during the onboarding process. Confidential technical files may be handled under a Non-Disclosure Agreement (NDA), and personal data is handled in accordance with applicable data-protection requirements.
Transparent Documentation
We aim to maintain clear and consistent records covering product identity, quantities, commercial documentation, shipment details, and the intended consignee and end use.
Humanitarian Trade
Sanctions & Humanitarian Trade
International sanctions frameworks recognize the importance of maintaining access to essential medical goods. The U.S. Iran sanctions framework includes longstanding humanitarian authorizations and exceptions supporting the commercial supply of qualifying medical devices to Iran.
Under the Iranian Transactions and Sanctions Regulations (ITSR),31 CFR § 560.530(a)(3) provides a general license for the export or reexport of qualifying medical devices to Iran without a separate, transaction-specific OFAC license in many circumstances. OFAC guidance also recognizes comparable allowances for non-U.S. persons, subject to the applicable conditions.
Official OFAC guidance and Frequently Asked Questions explain the scope of these authorizations, including the relevant product definitions, applicable restrictions, and due-diligence expectations. Manufacturers and suppliers can consult the following resources:
- OFAC — Iran Sanctions: Official Guidance and Resources
- OFAC FAQ 637 — Humanitarian Trade with Iran by Non-U.S. Persons
- OFAC FAQ 482 — General Authorization for Medical Devices
- OFAC FAQs 318, 319 and 483 — Product Scope and Specific Authorization
- OFAC — Guidance on the Sale of Medical Devices to Iran by Non-U.S. Persons
These resources provide a useful starting point for understanding the legal framework supporting humanitarian medical trade. The applicability of an authorization should be assessed in relation to the specific product, transaction parties, end use, country-of-origin requirements, and other applicable export-control and sanctions rules.
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Humanitarian Payment Frameworks
Swiss Humanitarian Trade Arrangement (SHTA)
The Swiss Humanitarian Trade Arrangement (SHTA) is an example of a specialized framework developed by Switzerland in coordination with relevant U.S. and Iranian authorities and selected Swiss banks and companies.
The arrangement was designed to facilitate transparent payments for humanitarian exports in the food, pharmaceutical, and medical-technology sectors. Its framework incorporates enhanced due diligence, supporting commercial and logistics documentation, and financial-institution review intended to improve transaction transparency.
The SHTA is a specific mechanism associated with eligible transactions and participating institutions, rather than a universal payment channel. Its current availability and eligibility should be confirmed with the relevant institutions before a transaction is structured.
The Swiss Federal Department of Foreign Affairs continues to identify the SHTA as one of the instruments supporting Swiss companies operating in a sanctions environment.
Swiss Federal Department of Foreign Affairs — Switzerland–Iran RelationsCompliance principle:Humanitarian authorizations provide an important framework for legitimate medical trade. They do not replace applicable export-control requirements, counterparty screening, banking due diligence, or any specific authorization required for an individual product or transaction.
Commercial Coordination
Regional Transaction Lanes — UAE, Türkiye & Pakistan
Sinoohe Medical commonly routes commercial and operational support through established regional hubs in Dubai, Istanbul, and Islamabad, working with non-U.S. counterparties where appropriate.
Depending on the transaction structure and the requirements of participating financial institutions, payment arrangements may useAED (United Arab Emirates dirham), EUR (euro) and PKR (Pakistani Rupees)corridors where feasible.
Coordination & Due Diligence
Our operational approach emphasizes coordination among relevant commercial partners, financial institutions, and logistics providers, supported by appropriate documentation and transaction-specific due diligence.
Depending on the product, route, and agreed Incoterms, supporting documents may include:
- Commercial invoices and product specifications
- Purchase orders and relevant contractual documentation
- End-user or end-use statements, where required
- Air waybills or other applicable transport documents
- Certificates of origin and customs documentation, where applicable
- Information identifying the consignee and other relevant transaction parties
Payment & Transaction Records
Payment arrangements, routing, and documentation are coordinated according to the requirements of the relevant counterparties and financial institutions. The availability of a particular payment corridor is confirmed for the transaction concerned.
Sinoohe Medical does not knowingly engage in prohibited dealings with restricted parties and seeks to maintain appropriate records supporting product traceability, transaction transparency, and auditability.
Local Regulatory Coordination
Iran Regulatory Pathway — IFDA
Importation of medical devices into Iran is subject to the applicable requirements of the Iranian Ministry of Health and Medical Education (MOHME) and the Iran Food and Drug Administration (IFDA).
Sinoohe Medical works with the relevant local parties to coordinate product documentation and the applicable registration and import-authorization process.
01 / Local Representation
Authorized Local Support
Importation and registration are handled through an appropriately authorized Iranian entity or representative, as required by the product category and applicable regulations.
02 / Product Documentation
Preparing the Technical Dossier
Depending on the product, risk classification, and regulatory pathway, the technical and regulatory dossier may include:
- ISO 13485 certification and other relevant manufacturer quality-management documentation
- Declaration of Conformity (DoC) and CE documentation, where applicable
- Free Sale Certificate (FSC) issued by the relevant competent authority, where required
- Technical documentation and product specifications
- Instructions for Use (IFU) and product labeling
- Product and packaging photographs
- Packaging specifications, shelf-life information, and storage conditions
- Additional documentation requested by the relevant regulatory authority
03 / Language & Labeling
Persian-Language Localization
Persian-language documentation, labeling, and Instructions for Use may be required as part of the applicable registration and import process. Where localization is necessary, manufacturers and suppliers should provide editable artwork and source files to support the preparation of Persian-language materials and the required label format.
04 / Registration & Post-Market
Planning for Market Entry
For many medical-device categories, the required registration and import authorizations must be completed before the first shipment. The applicable process and lead time depend on the device classification, the completeness of the dossier, and the requirements in force at the time of application.
Following market entry, applicable obligations may include safety-event reporting, post-market surveillance, product-change control, and the maintenance of relevant quality and traceability records.
The exact documentation requirements are determined by the applicable rules and the characteristics of the product. A document accepted for one product or market should not automatically be assumed to satisfy every Iranian registration requirement. Sinoohe Medical aims to clarify the applicable documentation and regulatory pathway with prospective partners at an early stage to support efficient planning and reduce avoidable delays.
Future Opportunities
Optional Localization — Market-Driven Opportunities
Where local regulatory requirements, healthcare procurement arrangements, or applicable incentives create a clear commercial advantage, Sinoohe Medical may explore opportunities for bulk importation combined with local packaging or finishing at a later stage.
Any such arrangement would be evaluated on a case-by-case basis and would require appropriate regulatory review, agreed quality-assurance and regulatory-affairs controls, validated processes where required, and qualified service providers.
Localization is considered an optional development opportunity rather than a prerequisite for initial cooperation. Product quality, regulatory compliance, traceability, and patient safety remain central to any proposed arrangement.
Partner Onboarding
Partner Documentation Checklist
To help manufacturers and suppliers prepare for an initial assessment, the following checklist outlines the information that may be requested during the onboarding process. Requirements vary according to the product, manufacturer, and applicable regulatory pathway.
Corporate & Compliance Documentation
- ISO 13485 and/or ISO 9001 certificates, as applicable
- CE documentation and Declaration of Conformity, where applicable
- Free Sale Certificate, where required
- Overview of the manufacturer's Quality Management System (QMS)
- Relevant vigilance and post-market surveillance procedures
- UDI, GMDN, and HS codes, where applicable
Technical Documentation
- Product catalog and technical specifications
- Bill of Materials (BOM), where required
- Instructions for Use (IFU) and product labeling
- Editable artwork and source files for Persian-language localization, where applicable
- Packaging specifications
- Shelf-life, storage, and handling requirements
Regulatory Documentation
- List of markets in which the product is registered or authorized
- Representative product-registration certificates, where available
- Relevant classification and regulatory information
- Additional technical or regulatory documents required for the applicable Iranian pathway
Commercial Information
- Minimum Order Quantity (MOQ)
- Indicative production and delivery lead times
- Sample availability and estimated preparation time
- Product pricing and quotation validity
- Packaging, order-volume, and supply-capacity information
- Commercial terms that support a sustainable and commercially viable transaction after applicable landed costs are considered
Legal & Cooperation Documents
- Non-Disclosure Agreement (NDA), where appropriate
- Manufacturer or supplier authorization for Sinoohe Medical to act as importer, distributor, or commercial representative in Iran, as applicable
- Relevant distribution, supply, or cooperation agreements
- Additional declarations or supporting documents required for the proposed arrangement
Lead times, sample schedules, and commercial terms are confirmed during product assessment and order planning; indicative timelines should not be treated as firm commitments before confirmation by the relevant parties.
International Cooperation
Working Together
Sinoohe Medical aims to establish cooperation through clear documentation, transparent commercial discussions, appropriate due diligence, and coordination of the relevant regulatory and logistical requirements. Prospective partners are welcome to share their product catalog, company profile, and available regulatory documentation for an initial review.
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