Ministry of Health

Ministry of Health of Kyrgyzstan

Regulatory Authority

Department of Pharmaceutical Supply and Medical Equipment

Medical Device Regulation

• National Regulation – Resolution of Government of Kyrgyz Republic No. 311 “About some questions related to registration of medical devices” July 05, 2018
• Centralized Regulation – Decision No. 46 “On the rules of registration and examination of safety, quality and efficiency of medical devices” February 12, 2016

Official Language

Kyrgyz, Russian

Classification

Class I, IIa, IIb and III

Registration Process

• Determine the device classification
• Appoint an Authorized Representative
• The application for registration may be filed either under National or Centralized procedure. The Centralized procedure is established by Eurasian Economic Union (EAEU)
• Conduct safety and efficacy tests in the EAEU authorized organizations
• Prepare and submit the Application Form and Registration Dossier
• The agency will out the necessary evaluations and manufacturing site inspections
• Once approved, the registration certificate will be issued.
• Information of the product should be made available in the State register
• Place the EAEU circulation mark on the device before placing the device on the market

Documents Required

• Application
• Registration dossier
• Safety and efficacy assessment report
• Inspection of the manufacturer
• Payment receipt
• Labelling, IFUs and User Manual
• Power of Attorney
• Product Description
• Marketing History
• Testing protocols
• Risk Analysis
• QMS

Post-market Requirements

• Serious threat to health immediately – 2 calendar days
• Death or unexpected serious deterioration – 10 calendar days
• Other – 30 calendar days

Registration Timeline

2-3 months

Authorized Representative

Yes

License Validity

Does not expire

Special Notes

• The registration dossier must be in English, with certain sections translated in Russian, and submitted electronically.
• IFUs or User Manual should be in Russian and/or Kyrgyz