Medical Devices Registration

Process of medical device registration in Russia

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

 

Stage 1

 

1. Import product samples.

 

2. Prepare documentation for the regulatory government agency.

 

3. Conduct trials:

 

  • technical

 

  • clinical    

 

  • toxicological and electromagnetic compatibility EMC (if required)

 

Stage 2

 

Send prepared documents to the registration governmental agency.

 

Stage 3

 

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

 

Stage 4

 

Receiving the Registration Certificate.

 

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

 

Stage 1

 

1. Import product samples.

 

2. Preparing documentation for the regulatory government agency.

 

3. Undergo following trials:

 

  • technical

 

  • toxicological and electromagnetic compatibility EMC (if required)

 

 

Stage 2

 

Send prepared documents to the registration governmental agency.

 

Stage 3

 

Amend the documentation based on the feedback from the governmental agency

 

Receive approval to conduct clinical trials

 

Stage 4

 

Undergo clinical trials

 

Receive confirmation of clinical trials

 

Stage 5

 

Send the results of clinical trial report

 

Stage 6

 

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

 

Stage 7

 

Receive the Registration Certificate

 

Offered Services:

Preparing required documents for importing the medical device

Evaluating documentation for the possibility to register device as a medical product  

Developing technical and operational documentation for the medical device

Managing registration process of the medical device as a turnkey service

Negotiating in conducting trials for the medical device with the laboratories and clinical trial centers

What is included in the registration process

 

  • Evaluation of documents for the possibility to register it as a medical device

  • 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

  • Inspection of Protocols

  • Amendment of documents based on the government agency's feedback