About Us
Established in 2005, Regen Marketing Limited works with International Medical Device Manufacureres to provide:
- Responsible Person (UKRP) Service with a special interest in niche sector, low volume, or low-priced Medical Devices.
- UKCA Registration with UK Medicines Health and Regulatory Authority (MHRA).
Our Services
UK Responsible Person
As your UK Responsible Person, we offer a low-cost, efficient UKRP service complying with UK Medical Device legislation.
Device Registration
We will efficiently achieve UKCA registration for your niche, low-volume or low-priced Medical Device with the UK authority – MHRA.
Why choose Regen Marketing as your UK Responsible Person? (UKRP)
- As your UK Responsible Person we will liaise with the UK MHRA, hold samples, and ensure both parties are compliant. Read more...
- We act independent of your sales agent or distributor leaving you flexible to make changes or appoint additional sales agents without impact upon your registration.
- Our consultancy fees are modest and concise allowing you to budget easily.
- We uniquely offer a commission-based scheme to help lower your market entry costs.
- We can also efficiently achieve UKCA registration for you. Read more...
To see Goverment Guidance: Click Here
What can you expect from us?
UK Responsible Person
We will act as your Responsible Person – a critical requirement for compliance with UKCA regulations managed by the Medicines and Health Regulatory Authority (MHRA).
As your UKRP we will:
- Keep available a copy of the Technical dossier, declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments for inspection by the MHRA.
- Cooperate with the MHRA on any preventive or corrective action required to eliminate or, if that is not possible, mitigate the risks posed by devices.
- Provide samples or access to the device should MHRA request it. Enquire
- Provide MHRA with all the information and documentation necessary to demonstrate the conformity of a device should they request it.