Regulatory Requirements are for selling Medical Devices in the Ukraine?

B

Burgmeister

#1
Hi all

We have a product that we are interested in selling in the Ukraine. The product has a CE mark and a 510(k), does anyone know what the regulatory requirements are for selling medical devices here?

Thanks in advance.
 
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Y

yana prus

#4
Hi,

State registration of medical device is an obligatory requirement for import, sale and marketing of device in Ukraine. State registration is performed centralized in Department of regulatory policy of medicinal products and goods of healthcare area of Ministry of Health of Ukraine that is located in Kiev.
Registered medical device is included to the State registry of medical devices of Ukraine. Registration certificate of medical device is issued for 5 years and can be renewed before expiry. Application for renewal of registration should be submitted not later than 90 days before the date of the expiry of registration certificate.

Structure of the registration dossier:​
Following list of documents is required for registration of the medical devices in Ukraine [download in MS Word format] :
  1. Application
  2. Annex to Application
  3. Power of Attorney
  4. Instruction, user's manual, catalogues, technical characteristics.
  5. Certificate of registration of the medical device in manufacturer's country.
  6. Certificate of origin or/and Free sales certificate.
  7. Manufacturing license, other manufacturer's certificates.
  8. CE certificate (Certificate of compliance to Directive 93/42/ ЕЕС ).
  9. Declaration of conformity with mentioned safety class referred to Directive 93/42/ ЕЕС .
  10. Certificates ISO 9001; ISO 13485. Other standard compliance certificates .
  11. Protocols of the preclinical and clinical studies, other studies and scientific information.
  12. Certificates of analysis/quality. Certificates for starting materials (frames).
  13. Sterility certificate is applied, validation of sterility.
  14. Labeling information.
more info here: http://www.cratia.com.ua/devices/newreg_eng.html

Regards,

Yana
 
B

Burgmeister

#5
Re: Requirements for Ukraine?

Thanks Ajit, I already tried that before posting my query. After the first 5 pages of results bearing no real info I gave up.

Yana, I had found the Cratia website but didn't find the page you linked to, so thanks for that. I notice it is dated 2007, so hopefully nothing has changed since.

Thanks everyone for your assistance, it is much appreciated.
 
M

MikeEmergo - 2010

#7
If you're still looking for help in Russia, YOU NEED A CONSULTANT IN Moscow. You are required to have an office or someone there to represent you. They do ALL their business face-to-face in Moscow.
 
Last edited by a moderator:
B

Burgmeister

#8
Thanks Mike, but at the moment I don't think we are looking at Russia. I think we are also shelving our plans for Ukraine due to the costs involved.

Thanks all for the advice offered.
 
T

theondine

#9
Also, not to forget that Ukrainian label and IFU are manadatory for product registration and import.
 
V

vitols

#10
Hi all!

is mandatory to appoint an Ukraine Authorized Representative? Or can a foreign manufacturer submit the application for medical device registration to Ministry of Health directly by himself?
 
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