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Services

We provide indemnity insurance that covers the amount of the state fee. If the state registration body rejects registration due to our fault, we will pay the state fee.

GET A CONSULTATION

— Medical device registration
— Development of documentation for medical device registration
— Medicines registration
— Amendments to dossier
— Marketing authorization amendments
— Consultations on medical device registration
— Documents auditing
— Import authorization
— Inquiry to Roszdravnadzor
— Marketing authorization replacement
— Duplicate marketing authorization
— Arranging and extending the validity period for specifications
— Selection of nomenclature classification
— Laboratory search/support
— Support in obtaining certificates/declarations of conformance
— Services for obtaining an explanatory letter (Letter of Exemption)
— Support in obtaining a certificate of registration
— Support in obtaining Technical Reglament Conformity Certificate (TRCU)
— Consultations related to trademark registration
— Electronic archive

EAEC Consultations

Get answers to any questions about the process and rules of registration, legal provisions of requirements by Roszdravnadzor. Our experts and lawyers will gladly share their knowledge.

ASK THE QUESTION

 

01 step

Preliminary examination

If you are already in the process of registration or only going to apply to RZN (Roszdravnadzor), send us your medical device documentation and we will:

  • Review the documents to assure compliance with Roszdravnadzor requirements
  • Submit the documents to the registration authority
  • Review the progress of dossier evaluation performed by Roszdravnadzor (it typically takes 5 working days)
  • Take into consideration remarks by the authority, if any

02 step

Medical device evaluation

  • State fee payment for the services of registration authority and testing
  • Production inspection by the regulatory authority — 90 working days
  • Laboratory testing — 60 working days
  • Period for eliminating the faults, if any — 60 working days for fault elimination
  • Submitting a written proof of payment to the member state concerned 

03 step

Approval of the expert report

  • Approval of the expert report in the member states concerned — 30 consecutive days
  • Submitting the information about the medical device in the EAEC unified register — 10 working days
  • Issuance of marketing authorization and annexes to it — 10 working days
Register medical device

Sergei Karnaukhov

EXECUTIVE DIRECTOR

Cooperating with the company MedRegExpert you may be sure that you will save your time, get state fee insurance, obtain marketing authorization at the first attempt, and get successful results of scheduled and random inspections. Our experts know their business really well. Among my employees are professionals highly competent in the sphere of registering medical devices. In our company, all the processes, algorithms, and regulations are strictly organized. The experts are given 30 working days to handle the registration and you will be regularly informed about the progress of your registration. A registration agent works only with one application. The whole team of MedRegExpert double check each action of the agent. In this way, we exclude any human factor errors. Due to our systematic approach, we provide high-quality services and obtain marketing authorization at the first attempt.