Registration Process of Medical Devices in CIS Countries

  • Ayesha bi Shaik Student
  • G. Ramakrishna Department of Regulatory Affairs, Hindu College of Pharmacy, Amaravathi Road, Guntur - 522002, Andhra Pradesh, India.

Abstract

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.

Keywords: Commonwealth of Independent States (CIS), Eurasian Economic Union (EAEU), Medical Device Regulation, guidelines, harmonization, IVDs, registration

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How to Cite
Shaik, A. bi, and G. Ramakrishna. “Registration Process of Medical Devices in CIS Countries”. International Journal of Drug Regulatory Affairs, Vol. 9, no. 2, June 2021, pp. 35-42, doi:10.22270/ijdra.v9i2.468.