Write to us

- fields, obligatory for filling.

Cost of registration. Contacts.

The cost and time of the registration procedure of medical devices in Ukraine is determined by the class of risk of the device and by assessment route.

The result of this procedure is receiving of the declaration of conformity or registration certificate what allows to sale free MD on territory of Ukraine.

In general the total cost of the registration procedure in Ukraine may consists from the following parts:

1. Compilation of the technical file on the Ukrainian language, its submission, preparing of application for conformity assessment body, the removal of nonconformities, preparation of the draft of marking with national symbol of conformity assessment, proof reading of the declaration of conformity (Annex 8 of the Technical regulation RCMU No.753)

2.assessment of technical documentation by notified body

3.audit (full quality assurance), inspection of production or product (Annex 3, 6, 7 of the Technical regulation RCMU No.753)

4.medical device/lot verification (Annex 5 of the Technical regulation RCMU No.753).

Here are the examples of calculation:

For medical devices of I class risk (not sterile and non measure) total cost is approximately 600,00 EUR (incl. services accordingly to point 1).  Terms of preparation - 2-4 weeks. Terms of validity of declaration - without terms.

For medical devices IIa (non-sterile) class risk can be used points 1 + 2 + 4, which is approximately 2200,00 EUR. Time - 60 days. It is lot/medical device verification and in this case certificate of conformity is limited by quantity of goods specified in shipping documents.

The cost of conformity assessment which involves an inspection/audit may start from 6000,00 EUR. Time of such assessment - 90-180 days. This price includes approximate expenses on preparation and assessent of technical file; fees of notified body; audit carrying out; flight, accommodation etc. Of course the price varies from a lot of parametres - quantity of production sites, quantity of the staff involved into production, distance of the locations and is individual for every particular case.  Customer gets certificate of conformity for the products which is valid 5 years and certificate on system quality assurance which is valid 3 years. Please, note that under this scheme the further observation audits will be required.

Please, contact us on s.kharchenko@yahoo.com to get more info about registration procedure (conformity assessment) in Ukraine and Authorised Representative service. You can get more info about our company and what service we provide from company profile. RAA_COMPANY_PROFILE.pdf