Medical Device Registration in the Russian Federation (Government Decree № 1684) Pro *registration period is up to 10 months

Professional Medical Device Registration in the Russian Federation (PRO Package)

Your Reliable Partner in Medical Device Registration

Elibrium Company offers an expanded range of services for medical device registration in accordance with the RF Government Decree № 1684. We provide a full cycle of work from documentation development to obtaining a registration certificate.

Full List of Services

Basic Registration:

• Medical device registration under RF Government Decree № 1684 (PRO package)

• Dossier compilation and submission through the elk.Roszdravnadzor system

Technical Documentation:

• Development of technical specifications

• Creation of operating manuals

• Compilation of qualification testing reports

• Development of risk analysis file

• Preparation of photographic image file

• Formation of regulatory documentation file

Testing Support:

• Technical testing

• Toxicological research

• Clinical trials

Additional Services:

• Product labeling preparation

• Revision of drawings and design documentation

• Product kit formation in compliance with Federal Laws 44-FL and 223-FL

• Full registration process support

• Handling of regulatory remarks

• Obtaining registration certificate

PRO Package Features

• Comprehensive Solution: all necessary services in one package

• Complete Documentation Set: dossier formation in electronic and paper formats

• Compliance: adaptation to 44-FL and 223-FL requirements

• Professional Support: from start to registration completion

Advantages of Working with Us

• Expert Approach: team of certified specialists

• Customized Plan: strategy development tailored to your product specifics

• Full Support: control of all registration stages

• Result Guarantee: obtaining registration certificate

• Timely Execution: strict adherence to agreements

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. We will help you bring your products to the market as efficiently as possible!

The registration of the PRO 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
• Preparation of product labeling
• Revision of drawings and other design documents
• Forming a set of products to meet the requirements of 44 and 223 FZ
• Collecting a complete set of dossiers for transmission to the
• Customer in electronic and paper form.