Medical Device Regulations for CIS (Commonwealth of Independent States) Countries

Elsmar Forum Sponsor
M

MedDev2011

#12
Re: Medical Device Regulations for CIS Countries

Does anyone know if there are any medical device regulations for disposable and/or implantable devices in Azerbaijan? I can find that there are pharmaceutical regulations but am not sure that the GOST-R applies or any other requirements. Any assistance is much appreciated.
 
A

Ana Fuduric

#13
Hello all,
Necessary new updated information about medical device ( i, I steril, II a) registration in Kazakhstan?
Thank you all in advance
 
J

just_RA

#14
I found this to be helpful as well from Emergo Group. They are a wealth of information. I tried posting a direct link but i am not allowed to as a newbie:(

Declaration of Conformity certificates are required in Russia and Belarus, and very effective toward obtaining certification in Kazakhstan, Georgia, Azerbaijan, Moldavia and Baltic Countries (but not Ukraine).
The following documents will be required for the Declaration of Conformity application:

  • Certificate of Registration in Russian Federation issued by Roszdravnadzor (legalized copy)
  • Contract for the supply of medical devices (if available)
  • Manufacturer brochure with product technical characteristics in Russian
  • Instructions for Use/Operations Manual in Russian
  • Protocols, test reports, given out by Russian accredited laboratories (valid for one year)
  • Safety Certificates issued by International Authorities
  • ISO 13485 or ISO 9001 certificate of the manufacturer
  • Declaration of Conformity with the list of product codes and product names
  • Product labeling, photo of the product or samples
 

swathi.sp

Starting to get Involved
#15
Dear folks,

Can anyone help me with medical device registration for CIS countries. We understand every CIS countries requires Local Authorised Representative in case of foriegn manufacturer. We have channel partner at Russia, and is that possible to consider my russian partner to register in other CIS countries. Please throw some light on this.
 
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