Registration of medical devices

Регистрация медицинских изделий

About us

Our goal is to help you register your medical devices in the Russian market in a timely and efficient manner.

 

We help you with all the stages of medical device registration starting from the initial documentation to the final stage of acquiring official registration certificate.

Stages of registration

We evaluate to which class of risk your medical belongs to, and based on that, we create a roadmap to successfully register your product.

1st class of risk and in-vitro

  1. Import product samples.
  2. Preparing documentation for the regulatory government agency.
  3. Conducting trials:
    1. technical
    2. clinical
    3. toxicological and electromagnetic compatibility EMC (if required)

Send prepared documents to the registration governmental agency.

Amend the documentation based on the feedback from the governmental agency.

Receiving the Registration Certificate.

2nd (A and B) and 3rd class of risk

  1. Import product samples.
  2. Preparing documentation for the regulatory government agency.
  3. Conducting trials:
    1. technical
    2. clinical
    3. toxicological and electromagnetic compatibility EMC (if required)

Send prepared documents to the registration governmental agency.

Amend the documentation based on the feedback from the governmental agency.
Receive approval to conduct clinical trials

Undergo clinical trials
Receive confirmation of clinical trials

Send the results of clinical trial report

Amend the clinical trial report based on the feedback from the governmental agency

Receiving the Registration Certificate

Rendered services

What is included in the registration process

  • Evaluation of documents for the possibility to register it as a medical device medical
  • Import medical device samples
  • Development of technical and operational documentations based on the information provided by the manufacturer
  • Evaluation of manufacturer's documentation that is necessary for the product registration
  • Negotiation of costs and time periods for trials with the laboratories (technical, toxicological, clinical and EMC)
  • Inspection of Protocols
  • Amend the documentation based on the feedback from the governmental agency.

You don't know where to start?

Ask for the consultation from our qualified specialist
He / she will assist you on your next steps and will answer your questions

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