Other ophthalmic instruments and appliances

Subheading 9018 50 of the Combined Nomenclature covers instruments and appliances used in ophthalmology that are not purely optical instruments classified elsewhere in Chapter 90. The subheading includes tonometers for measuring intraocular pressure, comprising non-contact (air-puff) tonometers, Goldmann applanation tonometers used with a slit lamp, and rebound tonometers. Direct and indirect ophthalmoscopes for fundus examination, including wide-field indirect systems, are covered, as are slit-lamp biomicroscopes used to examine the cornea, lens, vitreous body and retina. Automatic and manual perimeters and campimeters for visual field testing fall under this subheading, alongside electroretinographs (ERG) and visual evoked potential (VEP) recording systems used in electrophysiological diagnostics. Fluorescein angiography units and indocyanine green (ICG) angiography systems for retinal vascular imaging, as well as clinical optical coherence tomography (OCT) scanners where the predominant function is clinical diagnosis rather than purely optical measurement, are further examples of goods covered. Instruments for ophthalmic microsurgery such as vitrectomy machines and phacoemulsification units also fall under this subheading. The critical distinction is from purely optical instruments such as corrective lenses and spectacles (heading 9004), photographic cameras (heading 9006) and optical measuring instruments elsewhere classified. Classification follows GRI 1 and 6 of the Combined Nomenclature and the notes to Chapter 90.

Ophthalmic instruments under subheading 9018 50 are medical devices within the meaning of Regulation (EU) 2017/745 (MDR) and must comply with its requirements regarding clinical evaluation, technical documentation and post-market surveillance. The risk class of the device determines the applicable conformity assessment procedure: non-contact tonometers are typically Class IIa; indirect ophthalmoscopes and clinical OCT scanners may be classified as Class IIa or IIb - each device requires individual classification under the rules in Annex VIII of MDR. CE marking is mandatory; Class IIa and higher devices require certification by a notified body. Importers must hold an EORI number and file an electronic customs declaration in the AIS/IMPORT system with the correct 8-digit CN code. Required documents: commercial invoice with technical description, transport document, EORI number, EU Declaration of Conformity and technical specification. Electronic devices are additionally subject to the EMC Directive 2014/30/EU and the Low Voltage Directive (LVD) 2014/35/EU. All devices must be registered in the EUDAMED database. Non-EU manufacturers must appoint an authorised representative established in the EU. Applicable MFN duty rates and any autonomous suspensions should be verified in the current TARIC database of the European Commission.

Non-optical ophthalmic instruments under subheading 9018 50 fall within the medical device and diagnostic equipment sector, for which the European Union regularly applies autonomous tariff suspensions reducing import duties on products not manufactured in sufficient quantities within the EU. These suspensions are updated by the Council of the EU through annual amending regulations and may reduce applicable rates to 0%. The MFN duty rates for specific 8-digit CN codes must be verified in the current TARIC database of the European Commission each time a shipment is planned, as they may change annually with updates to suspension regulations and the Combined Nomenclature itself. Preferential duty rates are available under EU free trade agreements, including the EU-Japan EPA, EU-Korea FTA, CETA (Canada), EU-UK TCA and the bilateral agreement with Switzerland, as well as under the Generalised Scheme of Preferences (GSP and GSP+) for developing countries. A valid proof of origin is required to apply a preferential rate: EUR.1 movement certificate, invoice declaration or REX origin statement. Importers should check TARIC for any anti-dumping or trade defence measures applicable to the specific country of origin and product. VAT is charged at the rate applicable to medical devices in the country of import.

Subheading CN 9018 50 covers ophthalmic instruments other than optical: tonometers (intraocular pressure measurement), keratometers, autorefractors, pachymeters (corneal thickness), slit lamps with cameras, and electric ophthalmoscopes. Ophthalmic laser systems fall under 9013 20. The customs duty rate is 0%. All ophthalmic instruments are medical devices under MDR 2017/745.