1. To get a medical device approved in Ukraine, manufacturers must appoint an authorized representative in Ukraine who can be a distributor or representative office. The manufacturer then identifies the appropriate technical regulations for the device and chooses a conformity assessment procedure. 2. The manufacturer prepares a technical file demonstrating compliance with the requirements in the chosen regulations. They then select a Notified Body to review the file and certify compliance with quality standards. 3. Upon approval, the authorized representative's name and address and the Ukrainian conformity assessment mark must be placed on the device labels and packaging.

1. How to Get a Medical Device Approved
according to new Ukrainian Regulations?
1.To Appoint an authorized representative (AR) in Ukraine:
AR can be a distributor, a representative office or any third party
Manufacturer can either sign the special contract or grant the Power of Attorney.
2. To identify technical regulations appropriate for a medical device:
-technical regulation #753 – Medical devices
-technical regulation #754 – In vitro diagnostic devices
-technical regulation #755 – Active implantable medical devices
-Class I MD(non sterile, non
measuring)
-Some IVD
-Class I MD (sterile or measuring), Classes IIa, IIb, III
-A and B list IVD devices
-All active implantable devices
3.To chose conformity assessment procedure:
↓ ↓
Approval for 5 years
↓
Approval for production batch
(lot)
↓
3. To prepare technical file
(documentation) to demonstrate
compliance with check-list in
chosen regulations.
↓
4. To prepare technical file
(documentation) to demonstrate
compliance with check-list in
chosen regulations.
↓
4. To prepare technical file
(documentation) to demonstrate
compliance with check-list in
chosen regulations.
↓ ↓
5.To chose a Notified Body
(NB), to sign the contract and to pay
necessary fees
↓
5. To chose a Notified Body
(NB), to sign the contract and to pay
necessary fees
↓ ↓
6.To submit technical file for
expertise by NB, to eliminate
faults in the documentation (if
any)
↓
6. To submit technical file for
expertise by NB, to eliminate
faults in the documentation (if
any)
↓ ↓
7.To organize quality system
inspection by NB
↓ ↓
8.Based on previous steps NB
grants to AR conformity
assessment certificate
for 5 years
↓
7. Based on previous steps NB
grants to AR conformity
assessment certificate for bath
of products
↓
4.To prepare the declaration of
conformity (self-declaration)
↓
9. To prepare the declaration of
conformity (based on conformity
assessment certificate)
↓
8. To prepare the declaration of
conformity (based on conformity
assessment certificate)
↓
5. Put AR name, address and
Ukrainian conformity
assessment mark on device
labels and packaging.
↓
10. Put AR name, address and
Ukrainian conformity
assessment mark on device
labels and packaging.
↓
9. Put AR name, address and
Ukrainian conformity
assessment mark on device
labels and packaging.
Chart prepared by Alexey Stepanov for www.MedicalDevicesInRussia.com, August 2015