IOR Service

Importer of Record for Medical Devices & HealthTech

Structured customs compliance for diagnostic imaging, surgical equipment, clinical trial supplies, and HealthTech hardware. Built per device, per market, per regulator. Across 170+ countries.

IOR for Medical Devices & HealthTech

The legal entity registered with the destination country's customs and health authorities is accountable for the imported shipment. For medical devices and HealthTech products specifically, the IOR:

  • Manages medical device registration and coordinates approvals with destination health authorities
  • Files customs declarations, pays duties, and ensures UDI and product compliance requirements are met
  • Bears legal accountability for compliance with import regulations and healthcare frameworks

EOR for Medical Devices & HealthTech

The legal entity registered with the origin country's export authority is accountable for the outbound shipment. For medical devices and HealthTech products specifically, the EOR:

  • Classifies products under applicable export control regulations and screens parties against restricted-party lists
  • Obtains export licenses where required for controlled medical technologies
  • Files export declarations and ensures compliance with origin-country export regulations

What IOR Service Manages For Medical Devices & HealthTech

As your registered Importer of Record (IOR), IOR Service operates parallel compliance workstreams: customs compliance with the destination customs authority, and health authority registration with the medical regulator. The scope is structured around device classification, target market, and clinical use case.

Device Classification Review

We confirm destination-country classification — FDA Class I/II/III in the US, EU MDR Class I/IIa/IIb/III in Europe, equivalent national classifications elsewhere. Class determines the regulatory pathway and timeline. Misclassification carries regulatory and commercial consequences — accountability sits with us, by status.

Health Authority Registration

We manage FDA Establishment Registration and Device Listing for US imports; CE marking coordination and EUDAMED registration for EU imports under MDR 2017/745; SFDA Medical Device Marketing Authorization for Saudi imports; equivalent registrations with PMDA in Japan, NMPA in China, CDSCO in India, ANVISA in Brazil, TGA in Australia, HSA in Singapore.

FDA-Specific Requirements (US Imports)

For foreign manufacturers, we file the FDA Form 2877 (declaration for imported electronic products subject to radiation control), coordinate with FDA OASIS (Operational and Administrative System for Import Support), and act as the US Agent, where required, to hold FDA Establishment Registration on behalf of the manufacturer.

UDI Compliance

We confirm Unique Device Identification is correctly applied per device, register UDI in FDA GUDID (US) and EU EUDAMED (EU) databases, and maintain UDI traceability records through customs clearance and post-market. UDI is mandatory under FDA 21 CFR Part 801 and EU MDR Article 27.

Clinical Trial Supply Imports

For investigational devices, we manage clinical trial application (CTA) requirements per jurisdiction, coordinate with sponsor and CRO regulatory teams, and handle ancillary device imports for active clinical trials — eCOA, IRT, ePRO, IMP ancillary equipment.

Customs Declarations

We file import declarations with HTS classification for medical devices — typically 9018 (medical, surgical, dental instruments), 9019 (mechanotherapy and massage devices), 9022 (X-ray and other radiation apparatus), and 9027 (instruments for physical or chemical analysis, including many IVDs). Coordinated with the customs authority on classification queries.

Duty & Tax Payment

We pay import duties, VAT, and customs fees as the registered importer in each destination. Costs are billed transparently to the client as part of the engagement.

Audit-Ready Documentation

Every shipment is documented in accordance with the medical regulatory audit standard. 510(k) clearances, CE certificates, declarations of conformity, technical files, UDI records, and shipment-level documentation retained per jurisdiction (FDA: typically 2 years post-distribution for Class II; longer for Class III). Documentation is organized and retrievable for post-market surveillance audits.

Medical and Health-tech Equipment we import

IOR Service manages compliant imports across the full medical and HealthTech equipment landscape — from clinical trial supplies to hospital infrastructure to consumer health devices. Each category triggers distinct regulatory pathways and country-specific registration requirements.

Diagnostic Imaging Equipment

MRI scanners (Siemens MAGNETOM, GE SIGNA, Philips Ingenia), CT systems (Siemens SOMATOM, GE Revolution, Canon Aquilion), ultrasound platforms, X-ray and fluoroscopy systems, PET/CT scanners, mammography. Typically, Class II or Class III; multi-month regulatory pathways per country.

In Vitro Diagnostics (IVDs)

IVD analyzers, point-of-care testing devices, molecular diagnostics platforms, immunoassay systems, blood gas analyzers, and clinical chemistry analyzers. EU IVDR 2017/746 governs in the EU; FDA 510(k) or PMA pathway in the US. Reagents and consumables ship alongside hardware.

Surgical & Interventional Equipment

Surgical robots (Intuitive da Vinci, Medtronic Hugo), electrosurgical units, surgical microscopes, endoscopy systems (Olympus, Karl Storz, Pentax), surgical instruments, sterilization equipment, and autoclaves. Class II/III; sterility validation critical.

Patient Monitoring & Therapeutic Devices

Vital signs monitors, ECG/EKG devices, telemetry systems, infusion pumps, dialysis machines, ventilators, defibrillators, anesthesia workstations. Class II/III; cybersecurity requirements are increasing across major markets. Continuous clinical use makes IOR support for medical device maintenance and repair operations a parallel workstream for most hospital deployments.

Clinical Trial Supplies

Investigational medicinal product (IMP) ancillary devices, eCOA (Electronic Clinical Outcome Assessment) devices, IRT (Interactive Response Technology) systems, ePRO (Electronic Patient-Reported Outcomes) devices, mobile gateways for remote patient monitoring, and study-specific medical devices. Distinct regulatory pathway — clinical trial application required in each jurisdiction.

HealthTech & Digital Health

Connected wearables (continuous glucose monitors, smart inhalers), telehealth platforms and hardware, digital therapeutics devices, AI-enabled diagnostic tools, remote patient monitoring kits. Newer regulatory pathways — FDA SaMD (Software as a Medical Device), EU MDR Software classification.

Launch the device. We'll build the compliance framework.

From regulatory planning to documentation requirements, we provide the expertise needed to support international medical device deployments.

Device Classification & UDI Complaince

Medical Device Risk Classification

Medical device regulation is structured around risk classification. While classification systems differ by jurisdiction, higher-risk devices face more extensive regulatory pathways and longer pre-market approval timelines. Device class determines the registration pathway that the IOR Service manages on the buyer’s behalf.

UDI Compliance

Unique Device Identification (UDI) is mandatory across major medical device markets. The FDA mandates UDI under 21 CFR Part 801, while the EU MDR requires UDI under Article 27. UDI assigns each device a globally unique identifier through accredited issuing agencies such as GS1, HIBCC, or ICCBBA. IOR Service verifies correct UDI application, registers the device in relevant databases (FDA GUDID, EU EUDAMED), and maintains traceability records through customs clearance and post-market compliance. Non-UDI-compliant devices cannot legally enter major regulated markets.

FDA Classification (US Framework)

  • Class I — Low risk. General controls apply (tongue depressors, bandages, basic surgical instruments). Mostly exempt from premarket notification.
  • Class II — Moderate risk. Requires 510(k) premarket notification. Covers diagnostic imaging, patient monitoring devices, infusion pumps, and surgical instruments.
  • Class III — High risk. Requires Premarket Approval (PMA). Covers pacemakers, implantable defibrillators, orthopedic implants, and life-supporting devices.

EU MDR 2017/745 Classification

  • Class I — Low risk. Self-declaration of conformity for most basic devices.
  • Class IIa — Medium risk. Requires Notified Body assessment.
  • Class IIb — Higher medium risk. Requires Notified Body assessment plus design dossier review.
  • Class III — Highest risk. Requires Notified Body design examination plus type-examination. Covers implantables, surgical devices, and life-supporting devices.

IOR Cost Variables for Medical Device Imports

Device classification — Class III imports carry a higher compliance overhead than Class I/II

Classification and licensing complexity — multi-authority registration, UDI compliance scope, and clinical trial application coordination add scope

Destination market regulatory burden — FDA-regulated markets, EU MDR markets, and major Asian markets carry different operational costs

Shipment volume and program continuity — continuous import programs are priced differently from one-off shipments. Engagements take two structural forms: per-shipment pricing for one-off or low-volume imports, and structured retainer pricing for continuous, multi-market programs.

Why Choose IOR Service vs. the Standard Approach

IOR SERVICE

  • Registered IOR for medical devices in 170+ countries
  • Multi-authority coverage — FDA, CE/MDR, SFDA, PMDA, NMPA, ANVISA, and more
  • FDA Establishment Registration capability for foreign manufacturers
  • UDI compliance and GUDID/EUDAMED registration managed
  • Patient-safety-grade audit-ready documentation as standard
  • Class I / II / III pathway expertise across major markets

STANDARD APPROACH

  • Local entity registration required in each destination market
  • Separate regulatory consultants are required per country health authority
  • Foreign manufacturers must establish a US presence to import directly
  • UDI handling fragmented across multiple regulatory consultants
  • Documentation assembled on request; quality varies
  • Class III imports require external regulatory consultants per shipment

Other Industries we Serve

IOR Service operates compliance frameworks across eight technology-driven industries. Beyond medical devices and HealthTech, we manage:

Importer of Record for AI Hardware & IT Equipment

GPUs, AI accelerators, servers, storage, networking. ECCN classification, BIS Entity List, and AI Diffusion Rule compliance

Importer of Record for Telecom & Network Infrastructure

55G base stations, routers, switches, fiber-optic systems. Type approval and spectrum licensing across regulators

Importer of Record for Cloud & Data Centre

Hyperscale deployments, edge data center hardware. Multi-jurisdictional shipments synchronized across destination markets.

Importer of Record for Industrial Automation & Robotics

Smart manufacturing, sensors, control systems, robotics. Machinery directive compliance and industrial standards 

Importer of Record for Renewable Energy & CleanTech

Solar panels, inverters, battery systems. Project-scale imports and country-specific energy certifications

Importer of Record for Aerospace & Defense

Avionics, dual-use electronics. ITAR, USML, EAR dual-use compliance.

Importer of Record for Automotive & EV Components

ADAS, EV drivetrains, connected vehicle components. Country-specific homologation and type approval.

From Device Classification to Customs Clearance. One Entity of Record.

Accelerate market access. We'll handle the regulatory requirements. 

Email

info@iorservice.comFor compliance inquiries and assessment requests.

Direct Line

Available on request

Shared after initial assessment.

BACKED BY GCE LOGISTICS

25+ Years of International Trade & Compliance Leadership

Backed by decades of experience in global trade, IOR Service delivers the compliance frameworks, regulatory oversight, and market-entry expertise required for successful international operations. From highly regulated industries to complex cross-border projects, we help organizations move forward with certainty.

Frequently Asked Questions

Yes. The IOR is legally responsible for paying all import duties, VAT, customs fees, and applicable tariffs to the destination country's customs authority. For high-value medical device shipments — diagnostic imaging systems, surgical robots, and IVD analyzers can carry declared values in the hundreds of thousands per unit — the IOR's role as duty payer is operationally significant. IOR Service pays from our account as the registered importer; costs are then billed transparently to the client as part of the engagement. The structural reason IOR services exist for medical devices is that destination customs authorities require payment from a registered local party, and destination health authorities require registration from an established in-country entity.
Yes. Foreign manufacturers exporting medical devices to the US must designate a US Agent. IOR Service operates as the registered US Agent for foreign manufacturers — maintaining FDA Establishment Registration, filing the annual establishment registration fee, managing FDA correspondence and inspection coordination on the manufacturer's behalf, and serving as the official communication channel with the FDA. This eliminates the need for foreign manufacturers to establish a US subsidiary specifically to comply with FDA Initial Importer requirements. We also manage Device Listings in accordance with FDA Listing requirements, ensuring that every product the manufacturer exports to the US is properly registered.
Unique Device Identification (UDI) is mandatory across major medical device markets. The FDA requires UDI under 21 CFR Part 801; the EU MDR mandates UDI under Article 27. UDI assigns each device a globally unique identifier through an accredited issuing agency (GS1, HIBCC, ICCBBA). For IOR purposes, this means every imported device must have correctly applied UDI labeling AND be registered in the relevant health authority database (FDA GUDID in the US, EU EUDAMED in Europe). Non-UDI-compliant devices cannot legally enter major regulated markets — customs and health authority clearance both require UDI compliance documentation. IOR Service manages UDI verification, GUDID and EUDAMED registration, and maintains UDI traceability records as standard.
You don't get an IOR number — you engage an IOR entity. Engaging IOR Service for medical device imports involves three steps: first, you share your device classification (Class I/II/III or EU MDR equivalent), product details, destination markets, and whether imports are for commercial distribution or clinical trial supply; second, our compliance team reviews the regulatory pathway for each destination, FDA/CE/SFDA registration requirements, UDI compliance status, and any clinical trial application coordination needed; third, we return a regulatory pathway summary, documentation framework, and quote — typically within one business day. We then register as your IOR for each shipment, manage health authority registration, file customs declarations, maintain UDI compliance records, and bear legal accountability across both regulatory frameworks.