Registration Process of Medical Devices in CIS Countries
The Commonwealth of Independent States (CIS) is a region with constant, and often quite radical, changes in medical device regulations. This article summarizes the most significant new regulations in the largest CIS countries in order to provide a clearer picture of the regulatory requirements for medical devices in the region. The article also examines the new registration procedure for medical devices placed on the common market within the Eurasian Economic Union (EAEU) in accordance with the International Treaty within the EAEU. This Treaty defines the common principles and rules of circulation of medicinal products and medical devices.
2. Regulatory Affairs [Internet]. EUPATI; 2016 [cited 2021 Jan 04]. Available from: https://www.eupati.eu/glossary/regulatoryaffairs/
3. P. Praneeth, "Regulatory Affairs and its Role in Pharmaceutical Industry" SSRG International Journal of Pharmacy and Biomedical Engineering. 2016; 3(1):1-2. http://dx.doi.org/10.14445/23942576/IJPBE-V3I1P101
4. Gratisol. Regulatory Affairs – Interview Questions [Internet]. Gratisol; 2020 [cited 2021 Jan 07]. Available from: http://gratisol.com/index.php/life-sciencestraining/regulatory-affairs
5. Commonwealth of Independent States [Internet]. Cisstat; 2019 [cited 2021 Jan 06]. Available from: http://www.cisstat.com/eng/cis.html
6. List of Globally identified Websites of Medicines Regulatory Authorities. World Health Organization [Internet]. WHO; 2012 [cited 2021 Jan 05]. Available from: https://www.who.int/medicines/areas/quality_safety/ regulationlegislation/list_mra_websites_nov2012.pdf
7. List of Authority Websites – Tarius – Global Regulatory Requirements [Internet]. Tarius; 2018 [cited 2021 Jan 02]. Available from: http://www.tarius.com/?page_id=612
8. The Essential List of Regulatory Authorities in Asia [Internet]. RAPS; 2015 [cited 2021 Jan 04]. Available from: https://www.raps.org/regulatory-focus/newsarticles/2015/4/the-essential-list-of-regulatory-authoritiesin-asia
9. ICH CTD M4: The Common Technical Document [Internet]. ICH [cited 2021 Jan 09]. Available from: https://www.ich.org/page/ctd
10. Common Technical Document-Pharma Dossiers-CTD Format [Internet]. Perfect dossier; 2020 [cited 2021 Jan 09]. Available from: http://www.perfectdossier.com/ctddossiers.html
11. Jordan, D. An overview of the Common Technical Document (CTD) regulatory dossier. Medical Writing. 2014; 23(2):101-105. http://dx.doi.org/10.1179/2047480614Z.000000000207
12. Badjatya J. Overview of Drug Registration Requirements For Pharmaceuticals In Emerging Market. JDDT [Internet]. 15Mar.2013 [cited 16Jun.2021];3(2). Available from: http://jddtonline.info/index.php/jddt/article/view/466
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
The International Journal of Drug Regulatory affairs require a formal written transfer of copyright from the author(s) for each article published. We therefore ask you to complete and return this form, retaining a copy for your records. Your cooperation is essential and appreciated. Any delay will result in a delay in publication.
I/we have read and agree with the terms and conditions stated Page 2 of this agreement and I/we hereby confirm the transfer of all copyrights in and relating to the above-named manuscript, in all forms and media, now or hereafter known, to the International Journal of Drug Regulatory affairs, effective from the date stated below. I/we acknowledge that the IJDRA is relying on this agreement in publishing the above-named manuscript. However, this agreement will be null and void if the manuscript is not published in the IJDRA.
Download link for COPYRIGHT FORM