Medical Device Registration in the Russian Federation (Government Statement № 1684) Standard *registration period is up to 12 months

Medical Device Registration in the Russian Federation (Government Decree № 1684) Standard

Professional Registration of Medical Devices in the Russian Federation

Why Choose Us?

Elibrium Company is your reliable partner in the field of medical device registration. We offer a comprehensive range of services for obtaining regulatory documentation to bring your products to the Russian market.

Our Services

Comprehensive Medical Device Registration under the RF Government Decree № 1684 (standard package):

• Technical Documentation:

  • Development of technical specifications

  • Creation of operating manuals

  • Compilation of qualification testing reports

• Document Management:

  • Development of risk analysis file

  • Preparation of photographic image file

  • Formation of regulatory documentation file

• Testing Support:

  • Technical testing

  • Toxicological research

  • Clinical trials

• Registration Dossier:

  • Collection and preparation of documentation

  • Submission through the elk.Roszdravnadzor system

  • Registration process support

  • Handling regulator’s comments

  • Obtaining registration certificate

  • Transfer of the completed dossier to the client through elk.Roszdravnadzor

Advantages of Working with Us

• Experience and Professionalism: our team consists of certified specialists with years of experience in medical device registration

• Customized Approach: we develop a registration strategy tailored to the specific needs of your product

• Full Support: we handle all registration stages from documentation development to obtaining the certificate

• Timely Execution: we guarantee timely completion of all work stages

Cost of Services

It is determined depending on the number of models / variants of execution. The amount of materials used in MI depends on many other factors. Our specialists will calculate the cost of turnkey registration in the shortest possible time with the provision of detailed estimates of work.

Contact Us

Entrust the registration of your medical device to professionals. Contact us now to receive a free consultation and start the journey to bringing your products to the market.

The registration Standard includes the following services:

• Development of technical conditions
• Development of the operating manual
• Development of the act of qualification tests
• Developing a risk analysis file
• Developing a photographic image file
• Development of a file of information about regulatory documentation
• Maintenance of technical tests
• Support of toxicological tests
• Clinical trial support
• Dossier collection and submission to Roszdravnadzor (elk.Roszdravnadzor).
• Support of the registration process
• Working with comments
• Obtaining a medical device registration statement
• Delivery of the dossier to the Customer via elk.Roszdravnadzor