MHRA registration for medical device importers
A GB importer must tell the manufacturer or UK Responsible Person it intends to import; that party submits the importer’s details to MHRA. Agree the device information, obtain registration confirmation and check it against the goods before supply. Cambridge China Bridge helps buyers coordinate factory information.
Agree who handles registration
This guide covers Great Britain: England, Wales and Scotland. Our medical devices and PPE guide explains the product distinction and manufacturer roles. Here, the task is to organise the registration hand-off for your actual order.
A GB importer must inform the manufacturer or UK Responsible Person of its intention to import. The manufacturer or UK Responsible Person submits the importer’s details to MHRA, including its GB place of business. Name the person handling the submission and agree how they will confirm completion. Keep the notification and their reply in your purchase file.
Prepare matching information for DORS
DORS is MHRA’s Device Online Registration System. Prepare a shared information sheet for the registration owner: manufacturer’s legal name and address matching the packaging, company type, administrative contact and any UK Responsible Person designation letter. Ask the factory to distinguish the legal manufacturer from the trading company issuing your quotation.
For each ordered product, collect the applicable regulatory route, device class, GMDN code and term, brand name, model or version and catalogue reference. Include device identifiers where applicable, assessment body details and attributes such as sterility or latex content. MHRA also requires applicable conformity assessment certificates or self-certification declarations. Our CE, UKCA and ISO guide explains the different documents.
Close the importer-details hand-off
Send your legal business name, GB place-of-business address and a contact who can resolve questions. Identify the manufacturer and products you intend to import, attaching the agreed product sheet. Ask the registration owner to check the current DORS importer fields and request anything missing.
Ask for dated confirmation that your importer details have been added to the relevant manufacturer’s record, with a record extract or screenshot where available. Treat device registration and the addition of your importer details as separate checks. An email saying the factory is registered does not tell you whether your business details were submitted.
Verify the record before supply
MHRA does not regard a device as registered until device details have been supplied and registration confirmation received. Ask for that confirmation and the product details recorded in DORS. Compare them with your purchase order, declaration, certificates and final label artwork. An account acceptance email or draft application does not establish completed device registration.
Registration is not MHRA accreditation, certification, approval or endorsement. Check the underlying conformity evidence separately. As a purchase control, hold supply while unexplained differences in manufacturer, model, reference or sterile status remain. Use the quality inspection guide to organise checks that the goods and packaging match the agreed file.
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Keep the hand-off current
Information registered with MHRA must remain accurate and up to date. Agree that the factory and registration owner will tell you about changes affecting your products or business details. Keep the latest product sheet, importer-details confirmation, registration confirmation and conformity documents together.
Before accepting a revised model, manufacturer or UK Responsible Person, ask the registration owner to confirm the registration action needed and provide updated evidence. Cambridge China Bridge’s staff in China can help collect factory information and compare product references and packaging, while the manufacturer or UK Responsible Person handles its registration responsibilities.
Frequently asked questions
Does a GB medical device importer register itself?
For the importer-details hand-off, you notify the manufacturer or UK Responsible Person. That party submits your details to MHRA, including your GB place of business. Ask for confirmation that this has been done.
What information should I send for MHRA registration?
Send your business name, GB business address, contact and the products you intend to import. Agree a product sheet with manufacturer, model, catalogue reference and supporting documents; ask the registration owner to check current DORS fields.
Is a DORS account enough to supply medical devices?
No. MHRA requires device details and confirmation of device registration. Obtain the confirmation and compare the registered product details with your order before supply.
Does MHRA registration mean a device is approved?
No. Registration is not MHRA accreditation, certification, approval or endorsement. Check conformity documents and their product scope separately.