Medical devices export rules: United Kingdom

Rules to check before you export medical devices to the United Kingdom (3), each with its official source. Must clear before you sell: Main rule for medical devices.

Official sources checked between 2026-10-09 and 2026-11-10

Duty and FTAs: 0% duty for Korean-origin manufactured goods under the UK–Korea FTA with an origin declaration on the invoice; the UK Trade Tariff shows your heading. trade-tariff.service.gov.uk, checked 2026-10-09

This is not legal or tax advice. Rules and rates change, so confirm with the official source and a local authority, your importer or an expert before you sell.

• Main rule for medical devices: MHRA device registration through a UK Responsible Person; UKCA marking, or CE marking while it is still accepted in Great Britain (until 30 Jun 2028 or 30 Jun 2030, depending on the device). gov.uk, checked 2026-10-09
• Great Britain: MHRA device registration is an annual fee: MHRA device registration is charged every year from 1 Apr 2026 instead of once: £300 a year for each Level 2 GMDN category the manufacturer’s devices are registered under (the rate for 1 Apr 2026 to 31 Mar 2027, pro rata for registrations made during the year), and accounts with unpaid annual fees are suspended. Agree with your UK Responsible Person who pays it, and count it for every category you register. Done with your importer · gov.uk, checked 2026-11-10
• Great Britain: medical claims make a beauty device a medical device: In Great Britain the manufacturer’s claims in labelling, instructions and promotional material decide whether a product has a medical purpose: MHRA’s borderline guidance treats muscle-toning products and wrinkle treatments sold for a cosmetic purpose as outside the medical device rules, but similar products with medical claims, such as pain relief, may be medical devices under the UK Medical Devices Regulations 2002, and a medical device is registered with the MHRA before it is placed on the market. Keep ads, listings and the customer reviews you quote to cosmetic claims such as toning and appearance. Your company does it · gov.uk, checked 2026-11-10
• Open the checklist
• Work out the export price
• Same product, other countries: United States
• Same product, other countries: EU
• Same country, other products: Beverages
• Sources: gov.uk, checked 2026-10-09
• Sources: gov.uk, checked 2026-11-10
• Sources: gov.uk, checked 2026-11-10
• Sources: trade-tariff.service.gov.uk, checked 2026-10-09

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