To provide you with a UKRP and UKCA Product Registration Service we require the following:
PEOPLE
- Your full contact details.
- A web address if available.
- An English-speaking regulatory affairs representative.
PRODUCTS
- The number of Medical Devices you wish to cover.
- Their Classification and GDMN codes.
- A valid Declaration of Conformity.
More about MHRA statutory registration fees
A statutory fee of £250 applies for each registration application.
You can register up to 100 GMDN with 20,000 products within each application.
Renewals and Amendments:
The first renewal date is 1 year after account creation.
Then at least every 2 years.
There is currently no fee for renewal.
If you need to update any information within an existing registration, the MHRA will charge a new £250 statutory fee.