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MEDICAL DEVICE

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UKRP Services Fee For Medical Devices

Please select your chosen device type and risk class from the options provided below. Please keep in mind that the UKRP Services Fee shown are just meant as a basic guide. Following receipt of your proposal request, we will provide you with a comprehensive and detailed offer.

SL. No. ACTIVITY FEE EACH ADDITIONAL DEVICE
1 Annual United Kingdom Responsible Person £ 950 £ 50
2 MHRA Facility and Device Registration £ 500 £ 300
TOTAL £ 1450
3 Review and Correction of DOC including GMDN Code £ 300 £ 300
4 FSC Processing  £ 900 £ 400
5 Notary Attestation / Legalization of Documents (Embassy) £ 350

 

SL. No. ACTIVITY FEE EACH ADDITIONAL DEVICE
1 Annual United Kingdom Responsible Person £ 1150 £ 50
2 MHRA Facility and Device Registration £ 500 £ 300
TOTAL £ 1650
3 Review and Correction of DOC including GMDN Code £ 300 £ 300
4 FSC Processing  £ 900 £ 400
5 Notary Attestation/ Legalization of Documents (Embassy) £ 350

SL. No. ACTIVITY FEE EACH ADDITIONAL DEVICE
1 Annual United Kingdom Responsible Person £ 1250 £ 50
2 MHRA Facility and Device Registration £ 500 £ 300
TOTAL £ 1750
3 Review and Correction of DOC including GMDN Code £ 300 £ 300
4 FSC Processing £ 900 £ 400
5 Notary Attestation / Legalization of Documents (Embassy) £ 350

SL. No. ACTIVITY FEE EACH ADDITIONAL DEVICE
1 Annual United Kingdom Responsible Person £ 1350 £ 50
2 MHRA Facility and Device Registration £ 500 £ 300
TOTAL £ 1850
3 Review and Correction of DOC including GMDN Code £ 300 £ 300
4 FSC Processing £ 900 £ 400
5 Notary Attestation / Legalization of Documents (Embassy) £ 350

UKRP Services Fee For In-Vitro Diagnostic Devices

SL. No. ACTIVITY FEE EACH ADDITIONAL DEVICE
1 Annual United Kingdom Responsible Person £ 950 £ 50
2 MHRA Facility and Device Registration £ 500 £ 300
TOTAL £ 1600
3 Review and Correction of DOC including GMDN Code £ 300 £ 300
4 FSC Processing £ 900 £ 400
5 Notary Attestation / Legalization of Documents (Embassy) £ 350

SL. No. ACTIVITY FEE EACH ADDITIONAL DEVICE
1 Annual United Kingdom Responsible Person £ 1100 £ 50
2 MHRA Facility and Device Registration £ 500 £ 300
TOTAL £ 1600
3 Review and Correction of DOC including GMDN Code £ 300 £ 300
4 FSC Processing £ 900 £ 400
5 Notary Attestation / Legalization of Documents (Embassy) £ 350

SL. No. ACTIVITY FEE EACH ADDITIONAL DEVICE
1 Annual United Kingdom Responsible Person £ 1200 £ 50
2 MHRA Facility and Device Registration £ 500 £ 300
TOTAL £ 1700
3 Review and Correction of DOC including GMDN Code £ 300 £ 300
4 FSC Processing £ 900 £ 400
5 Notary Attestation / Legalization of Documents (Embassy) £ 350

SL. No. ACTIVITY FEE EACH ADDITIONAL DEVICE
1 Annual United Kingdom Responsible Person £ 1300 £ 50
2 MHRA Facility and Device Registration £ 500 £ 300
TOTAL £ 1800
3 Review and Correction of DOC including GMDN Code £ 300 £ 300
4 FSC Processing £ 900 £ 400
5 Notary Attestation / Legalization of Documents (Embassy) £ 350

The Payment in Advance.

Customer must provide signed Declaration of conformity in company letterhead.

The GMDN Code must be clearly mentioned in the DOC.

UKRP Agreement Signing 3-4 working days.

MHRA Registration timeline is 10-14 working days.

Valid CE Certificate or UKCA Certificate is mandatory for Class Is,m,r / Class IIa, Class IIb and Class III Devices