Computed tomography apparatus

CN subheading 9022 12 of the Combined Nomenclature covers computed tomography (CT) apparatus - also known as CT scanners - specifically for medical and dental applications. A CT scanner generates three-dimensional cross-sectional images of the human body using X-radiation emitted by a rotating X-ray tube and detected by a ring of solid-state or scintillator detectors. Subheading 9022 12 encompasses: multi-slice spiral CT systems (MSCT) ranging from 4 to 640 or more detector rows, used in general diagnostic, oncological, cardiological and vascular imaging; dedicated cardiac CT scanners with ECG gating and prospective triggering; cone beam computed tomography (CBCT) systems for dental and ENT applications; intra-operative CT systems deployed in hybrid operating theatres; combined PET/CT systems integrating positron emission tomography with computed tomography; and SPECT/CT hybrid systems. The decisive classification criterion distinguishing subheading 9022 12 from the residual subheading 9022 19 is the medical or dental intended purpose as stated by the manufacturer in the device documentation and labelling. Industrial CT systems for non-destructive testing, materials analysis and quality control of manufactured components are classified under 9022 19. Classification follows GRI 1 and 6 of the Combined Nomenclature and the notes to Section XVIII and Chapter 90. Binding Tariff Information (BTI) is recommended for borderline cases.

CT scanners classified under CN 9022 12 are medical devices emitting ionising radiation, subject to Regulation (EU) 2017/745 (MDR). Pursuant to Rule 10 of Annex VIII to the MDR, medical devices emitting ionising radiation and intended for diagnostic medical imaging are classified as Class IIb devices. Class IIb conformity assessment requires mandatory involvement of a Notified Body. The manufacturer must prepare comprehensive technical documentation including a clinical evaluation, a radiological risk assessment demonstrating dose optimisation, and implement one of the conformity assessment modules applicable to Class IIb (Module B+C, B+D, B+E, B+F or H1). CE marking with the four-digit Notified Body identification number is mandatory on the device and its packaging. Council Directive 2013/59/Euratom (BSS) requires Member States to ensure justification of CT exposures, implementation of diagnostic reference levels (DRLs) for CT examinations calibrated in terms of CT dose index (CTDI) and dose-length product (DLP), and continuous dose optimisation (ALARA). Operators of CT equipment must hold a national radiological operating authorisation. Each CT scanner must be registered in EUDAMED and carry a Unique Device Identifier (UDI). The manufacturer or EU authorised representative issues an EU Declaration of Conformity. Importers must hold an EORI number. Required documents: commercial invoice with technical description, transport document, EU Declaration of Conformity, Notified Body certificate, technical specification with dosimetric parameters (CTDI, DLP, mAs, kVp ranges). Requirements should be verified in TARIC and with the relevant national supervisory authorities.

CT scanners under CN 9022 12 as highly advanced medical imaging systems fall within the category for which the EU may apply autonomous tariff suspensions reducing import duties on equipment not available in sufficient quantities in the Union. These suspensions are reviewed and updated annually by the Council of the EU by regulation, published in the Official Journal of the EU. The applicable MFN duty rate for CN code 9022 12 must be verified in the current TARIC database of the European Commission, as rates may change. The CT scanner market is dominated by manufacturers from the United States, Japan, Germany and China, making the following FTA preferential rates particularly relevant: the EPA with Japan, CETA with Canada, the Trade and Cooperation Agreement with the United Kingdom, and the bilateral agreement with Switzerland. GSP and GSP+ preferences are available for eligible developing country exporters. A valid proof of origin is required to benefit from a preferential rate: EUR.1, invoice declaration or REX exporter statement. Advanced CT systems incorporating artificial intelligence image analysis or specialised post-processing software should be assessed against dual-use control lists under Regulation (EU) 2021/821 before importation. Importers should verify in TARIC whether anti-dumping or countervailing measures and EU sanction restrictions apply for the specific country of origin. Chapter 90 products are not subject to the CBAM mechanism. VAT is levied at the applicable national rate. TARIC should be consulted before every import operation.

Subheading CN 9022 12 covers medical computed tomography (CT) scanners - advanced imaging systems using X-ray radiation to create cross-sectional body images. These are Class IIb medical devices (MDR 2017/745) subject to EURATOM regulations. CT scanners valued at EUR 200,000–2,000,000 represent one of the most capital-intensive medical import segments. Duty rate: 0%. Import requires full MDR documentation and radiation source authorisation.