Importing Refurbished Medical Imaging Equipment

Note. This guide is general information for planning purposes, not legal or regulatory advice. Requirements differ by country and change over time. Confirm the position with the competent authority at the destination and with a customs broker before shipping.

1. Get the terminology right first

The market uses several words loosely, and they carry different regulatory weight:

Term	Common meaning in the market
Used / pre-owned	Sold in current condition as removed from the previous site, with no defined process applied
Refurbished	Inspected, worn parts replaced, cleaned, reassembled, calibrated and tested to a defined process, with documentation
Fully refurbished / OEM refurbished	Processed under the original manufacturer's own programme, typically with a warranty comparable to new
Remanufactured	Rebuilt to a degree that can change the device's characteristics or intended purpose — regulatorily the most sensitive category, and in some jurisdictions it can bring manufacturer obligations

Ask for the actual scope of work performed and the test results, rather than accepting the label. What was replaced, what was tested, against what specification, and who signed it off.

2. CE marking and the EU framework

Within the European Union, medical devices are governed by Regulation (EU) 2017/745 (MDR). A device legally placed on the EU market carries a CE mark, and evidence of that original conformity should travel with the equipment — declaration of conformity, technical documentation references, and the system label.

The MDR does not set out a single, complete regime for refurbishment of used devices, and national interpretation varies across member states. In practice this means two things: first, keep the original conformity evidence with the device; second, check the specific position of the destination member state if the equipment is being reintroduced or substantially reworked, because 'refurbishment' can shade into activities that carry manufacturer obligations.

3. Destination-country requirements outside the EU

This is where most import problems originate. Requirements vary widely, and common patterns include:

• Age limits — some countries refuse import of used medical devices above a stated age from date of manufacture
• Prior import authorisation — a permit that must be obtained before shipment, not on arrival
• Device registration — the model must be registered with the national authority, sometimes only possible via the manufacturer or an authorised representative
• Certificate of free sale or equivalent from the country of origin
• Pre-shipment inspection by a nominated body
• Local representative requirement — an in-country entity holding the registration
• Refurbishment certificate and functional test report from the refurbisher

Establish these at the quotation stage. An MRI held at a port while a registration is obtained accrues storage and demurrage quickly, and in the worst case the shipment is refused entry.

4. Radiation-emitting equipment: an extra layer

CT, X-ray, fluoroscopy, mammography and angiography systems are regulated as radiation sources in addition to being medical devices. Expect a separate process involving the national radiation protection authority: notification or authorisation of the installation, a shielding design by a qualified expert, acceptance testing by a qualified medical physicist, and registration of the source before clinical use.

MRI does not emit ionising radiation and so avoids this layer, but it brings its own safety regime around the static field, cryogens and RF.

5. Customs classification and duty

• MRI apparatus — normally HS heading 9018.13
• CT apparatus — normally HS heading 9022.12
• Other X-ray apparatus falls under other subheadings of 9022; local tariffs extend these headings with further digits

Duty and VAT treatment for used medical equipment varies, and some countries operate relief schemes for hospitals or charitable importers that require documentation obtained in advance. Confirm classification, duty rate and any relief with a broker at the destination before shipping. Also confirm valuation basis — customs may not simply accept the invoice value for used capital equipment.

6. The document pack

• Commercial invoice and detailed packing list, with serial numbers
• Bill of lading, air waybill or CMR
• Certificate of origin where required
• CE declaration of conformity or equivalent original conformity evidence
• Refurbishment certificate, scope of work and test report
• System label photographs showing model, serial number and year of manufacture
• Import permit or device registration evidence for the destination
• ISPM 15 evidence for wooden packaging
• Insurance certificate
• User and service manuals

7. Practical sequence that avoids surprises

1. Identify the destination country's rules for used medical devices before agreeing to buy
2. Confirm whether the specific model is registrable, and by whom
3. Confirm any age limit against the system's year of manufacture
4. Fix Incoterms and establish who is importer of record
5. Assemble the document pack before shipping, not while the container is at sea
6. Engage a customs broker experienced with medical equipment at the destination
7. For CT and X-ray, start the radiation authority process in parallel with the shipment
8. Plan acceptance testing and physicist sign-off into the programme

Quick summary

• Ask what was actually done, not what the equipment is called
• Keep original CE conformity evidence with the device
• Check destination age limits, permits and registration before buying
• Budget an extra regulatory layer for anything that emits ionising radiation
• Confirm HS classification and duty with a local broker in advance
• Have the full document pack ready before the equipment ships

Frequently asked questions

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Published 2026-08-12 by Radiology Invest Group, Bucharest, Romania. General information for planning purposes; always confirm requirements against the equipment manufacturer's documentation and the applicable authority at your destination.