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

AG Kumar

Starting to get Involved
#1
Hi

I am wondering if any of you can help me in getting/finding the regulations or harmonized regulatory agency for marketing medical devices/IVDs in CIS countries.

I hardly find information in web searches.

AG Kumar
 
F

freelovefest

Guest
#2
Re: Medical Device Regulations for CIS Countries

I know where you can get the info, but it isn't cheap. A website called clinivation has their "worldview" regulatory intelligence program where you can buy a dossier of info, generally for $800USD or so. Which states in particular are you looking for? If I knew that I could let you know some more specifics.

My understanding of this is that for the most part most CIS countries (Assuming you mean the commonwealth of indiependent states) adhere to one of two major regulatory models; the EU requirements or those of Russia. It just depends on where their allegiances are for that day.

If you have done business over there before you probably already know that a little "grease" is always a lot more effective at opening the market than some completed forms or reports.......
 

AG Kumar

Starting to get Involved
#3
Re: Medical Device Regulations for CIS Countries

Thanks for the info. I understand what you meant, however I am keen to know the requirement that I can apply in case of any eventual need arises.

There have been a huge business need to CIS (Commonwealth of Independent States) countries for both Therapeutic & device products and it would become a need for me to know the regulations.

AG Kumar
 

AG Kumar

Starting to get Involved
#4
Re: Medical Device Regulations for CIS Countries

I checked at Clinivation's 'Worldview' and it does not list any of the Commonwealth of Independent States regulatory requirement. I hardly find information about any regulatory agency for these countries.

I am looking for informations particularly to the countries Azerbaijan, Kazakhstan, Kyrgyzstan and Uzbekistan. Helpful, if some information can be shared.

AG Kumar
 
#5
Re: Medical Device Regulations for CIS Countries

The certification for CIS countries is quite difficult issue. First of all, you should follow to National Legislation of the country. Most of CIS countries habit certification structure based on Russian System. For example, in each country you have to go through following Bodies:
1. Ministry of Health. Registration is required
2. Hygenic Department, if any
3. Certification Body for Medical Devices.
If you have more questions, pls do not hesitate and contact with me +74959203829
 

Ajit Basrur

Administrator
Staff member
Administrator
#6
Re: Medical Device Regulations for CIS Countries

Hi vic197910,

Welcome to the cove :bigwave: and great to have your participation. :applause:
 
#7
Re: Medical Device Regulations for CIS Countries

Hi, you are welcome. Hope I will be able to participate in discussions soon, as well as my colleagues.
 

lilybef

Involved In Discussions
#8
Re: Medical Device Regulations for CIS Countries

Hi -

Hope this helps. It is a listing that one of our distributors (glucose monitoring systems) sent to us for the requirements for Kazakhstan.

Enclosure 4
To the regulations of State registration (re-registration) of medical means including medical equipment and amendments to registration file on medical means including medical equipment.

List of documents required for registration or re-registration of medical equipment

1. Application in the approved format (both in electronic and hard copies).
2. Document confirmed the State Registration or copy of the State Registration of the manufacturer’s enterprise issued in the country of manufacture, which includes a list of all components (main parts and components, materials).
3. Information of registration in other countries confirmed by the copies of registration certificates.
4. Power of Attorney from the manufacturer allowed registration process execution. Notarized by the Notary Public
5. **Certificate of sale permission (export permit).
6. ***Certificates confirmed that product complies with the requirements of international or national standards, including conditions of product manufacture (Quality Certificate issued in the country of manufacture).
7. Copy of the Registration Certificate of a tool as a measurement instrument issued by country of manufacture or other countries.
8. Methods of measurement instruments testing
9. Copy of the document (minutes, reports) of medical measurement instrument tests approval, executed in the country of manufacture or other countries.
10. Copies of toxicological hazard test safety reports (minutes) executed in the country of manufacture including exact specifications of the components of proposed medical equipment.
11. Copies of the documents (reports) of technical tests executed in the country of manufacture on medical equipment.
12. Copy of the report of medical tests executed in the country of manufacture.
13. Copy of the sanitary inspection report executed in the country of manufacture on medical equipment.
14. Report of precious metal occurrence or its absence (including quantity) in proposed medical equipment.
15. Operating Manual on proposed medical equipment approved by the manufacturer’s official seal.
16. Draft Operating Manual for the medical staff, in Russian (both in electronic and hardcopy formats), see p. 15.
17. Draft Operating Manual (note, insert) for the consumers, both in the language of manufacturer’s country and Russian (both in electronic and hardcopy formats), see p. 15.
18. Sample of medical devices (in quantities sufficient for the tests repeated three times). If necessary, samples of medical equipment, required for clinical tests, should be provided.
19. Information of stability (for medical equipment), not less than in tree series.
20. Normative documents on packaging materials for medical equipment.
21. Promotional illustrative materials.
22. Photograph, minimum size 130x180 mm.
23. Color models of packaging and labels for medical equipment (both in electronic and hardcopy formats). Certified by the official seal of the applicant.
24. Copy of a patent or other product certificate

Notes:
** Documents required only for the manufacturers from the foreign countries.
***Documents required for the manufacturers from both foreign countries and newly independent States.
Documents not marked specifically are required for all applicants.
Documents should be submitted in the language of manufacturer’s country and Russian (2 originals and 2 notarized copies including Apostille.

Good Luck!!
Beth
:bigwave:
 
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