Compliance & Regulatory

We are committed to lawful, transparent, and safe access to medical disposables. The information below outlines how we operate with our partners. Nothing here is legal advice; manufacturers should obtain counsel for their own compliance programs.

Our compliance principles

  • Humanitarian first: medical disposables supplied under applicable humanitarian exemptions and authorizations.
  • Know-your-counterparty: enhanced due diligence on suppliers, buyers, banks, and logistics providers; screening against restricted-party lists.
  • Traceability & safety: ISO‑anchored QMS (ISO 13485/9001), batch traceability, vigilance, and post‑market processes.
  • Data minimization: protect confidential technical files under NDA; handle personal data per applicable laws.

Sanctions & humanitarian trade (high‑level)

  • The U.S. Iran sanctions program includes a humanitarian channel for agricultural commodities, medicine, and medical devices under 31 CFR § 560.530 (ITSR). For the purposes of the ITSR, the term medical device follows the FD&C Act device definition, subject to exclusions (e.g., items on the Commerce Control List and devices listed as requiring specific authorization). citeturn0search6turn0search12
  • OFAC’s framework generally authorizes exports/reexports of medical devices to Iran except for certain devices and counterparties that are excluded; some devices remain on a list requiring specific licenses. Partners must confirm their products are either covered by the general license or not otherwise prohibited.
  • Selected payment channels operate with enhanced due diligence for humanitarian trade. For example, Switzerland’s SHTA mechanism was established in coordination with U.S. and Iranian authorities and Swiss banks specifically for food, pharmaceutical and medical sectors.

Important: Authorization under the ITSR does not override other export‑control laws or banking policies. Transactions remain subject to bank KYC/AML checks and potential secondary‑sanctions risk assessments. Manufacturers should consult their counsel.

Regional transaction lanes (UAE / Türkiye)

  • We commonly route commercial and operational support via regional hubs in Dubai and Istanbul with non‑U.S. counterparties, using bank corridors in AED/EUR where feasible. Banks apply heightened KYC/EDD; we align documentation, end‑user statements, and logistics proofs accordingly (Incoterms, airway bills, certificates of origin). (Illustrative; exact structures depend on partner policy and bank requirements.)
  • We do not work with restricted parties, and we keep full audit trails on product identity, quantity, and ultimate consignee/end‑use.

Iran regulatory pathway (IFDA)

  • Local representation: imports are handled by an authorized Iranian entity.
  • Core documents typically requested by IFDA: ISO 13485 certificate, Declaration of Conformity/CE (where applicable), Free Sale Certificate (FSC) from the competent authority, technical files (IFU, labels), and product photos/packaging. citeturn0search15
  • Language & labeling: documentation and labeling/IFU must be provided in Persian; localization of artwork and instructions is part of the file. citeturn0search15turn0search24
  • Registration & import: MOH/IFDA registration is required before first shipment of most risk classes; timelines vary by device class and dossier completeness. Post‑market obligations include vigilance reporting and change control.

Optional localization (incentive‑led)

Where MOH incentives or tender rules create a clear advantage, we may consider bulk import with local packaging/finishing in later phases under agreed QA/RA controls, validated processes, and qualified service providers. Commercial growth and patient safety remain primary.

Partner documentation checklist (for fast onboarding)

  • Corporate & compliance: ISO 13485, CE/DoC (if applicable), FSC, QMS overview, vigilance SOPs, UDI/GMDN/HS codes
  • Technical: catalog, bill of materials (where needed), IFU/labels (editable for FA), packaging specs, shelf‑life & storage
  • Regulatory: list of markets where registered, sample registration certificates
  • Commercial: MOQ, lead time (target ≤ 45–60 days), sample timing (2–3 weeks), price lists enabling ≥ 30–40% GM after landed costs
  • Legal: NDA, authorization for Atipay/affiliate to act as importer/distributor in Iran