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I will manage your mhra registration and UK device classification for medical devices
Sammy Dan
Informazioni su questo servizio
Placing a medical device on the UK market without MHRA registration means customs holds, rejected listings, and lost revenue. Manufacturers, importers, and distributors need it handled correctly the first time, not delayed by misclassification or incomplete files.
I provide complete mhra registration support for medical devices, IVDs, and surgical instruments, covering device classification, GMDN coding, and full DORS portal submission. You receive an audit ready application and a clear compliant path to sell legally in Great Britain.
What you get:
- Device classification under UK MDR 2002
- GMDN code identification and verification
- Full MHRA registration and DORS submission
- UK Responsible Person guidance for non-UK manufacturers
- UKCA declaration of conformity support
- Technical file review and gap analysis
- Post-submission tracking until confirmation
Suited to manufacturers, importers, and distributors placing Class I, IIa, IIb, or IVD devices on the UK market, including non-UK companies needing a clear compliant route in.
Message me before ordering to discuss your mhra registration needs so I can confirm classification and the right package.
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Sammy Dan
FDA registration and compliance support for food cosmetics and devices
- DaStati Uniti
- Membro daago 2026
- Tempo di risposta medio2 giorni
Lingue
Inglese
I help food brands, cosmetic companies, importers, and medical device businesses organize FDA registration and compliance documents. My services include food facility registration, FDA import permit assistance, cosmetic registration, MoCRA preparation, product listing support, medical device documentation, and focused 510k assistance. I deliver clear checklists, careful document reviews, and practical submission guidance with a professional and confidential approach.
Altri servizi della categoria Consulenza sulla conformità normativa offerti da me
FAQ
What is included in mhra registration for medical devices?
Mhra registration includes device classification under UK MDR 2002, GMDN code identification, and full submission through the DORS portal. Every application is reviewed for accuracy before it reaches the regulator.
How long does mhra registration take to complete?
Timelines vary by device class, but most straightforward mhra registration submissions are prepared and filed within the agreed delivery window. Complex IVD or Class IIb devices may need additional technical file review time.
Do I need a UK Responsible Person for mhra registration?
Non-UK manufacturers generally need a UK Responsible Person to complete mhra registration and hold technical documentation on their behalf. I can guide you through appointing one as part of the registration process.
Can you handle mhra registration for IVD devices?
Yes, mhra registration support covers in vitro diagnostic devices alongside general medical devices and surgical instruments. Classification and GMDN coding are confirmed before the IVD application is submitted.
Will mhra registration also cover UKCA marking?
Mhra registration and UKCA documentation are closely linked, since most devices sold in Great Britain need both. I prepare the declaration of conformity and supporting UKCA files alongside your registration.
