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인쇄

CIS·Russia

EAC certification system GOST-R certification system GOST-K certification system GOST-U certification system Russia medical device registration

Outline for Russia medical device registration

To export medical device to Russia, Registration Certificate must be achieved in Federal service on surveilance in healthcare /ROSZDRAVNADZOR).

Medical device registration procedure

러시아 의료기기 등록 단계 및 절차, 담당
Stage Procedure Charge
1 Technology and toxicology test Laboratory in Russia
2 Technology and toxicology test report and other essential information submission ROSZDRAVNADZOR
3 Check registration status of essential document for submission
4 Primary inspection and supplementation request
5 Supplementary information submission Manufacturer
6 Evaluation of supplementary information and decision on possibility of clinical assessment ROSZDRAVNADZOR
7 Clinical assessment ROSZDRAVNADZOR Designated clinic
8 Secondary evaluation and supplementation request ROSZDRAVNADZOR
9 Supplementary information submission Manufacturer
10 Evaluation of supplementary information and decision of issuing registration certificate ROSZDRAVNADZOR
11 Issue registration certificate ROSZDRAVNADZOR

Required document

  • - Business license of manufacturer
  • - ISO 13485 certificate
  • - Techical document(TCF)
  • - Manual
  • - Clinical test report or relevant article
  • - Risk Assessment data
  • - Picture of product and sample

※ Above list is for necessary document for submission and depending on request from ROSZDRAVNADZOR extra document is required.

Point of contact

담당자 - Name, Tel, E-mail
Name Position Task Tel E-mail
Park Jinjae Manager KC, CB, CCC, CE etc Global Certificate +82-2-2164-1479 jjpark@ktr.or.kr