Medical Device Registration in the Russian Federation (Government Decree № 1684) Business *registration period is up to 8 months

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

Your Reliable Partner in Medical Device Registration

Elibrium Company presents a premium package of services for medical device registration in accordance with the RF Government Decree № 1684. We provide a full cycle of work from market analysis to obtaining a registration certificate and subsequent support.

Full List of Services

Basic Registration:

• Medical device registration under RF Government Decree № 1684 (BUSINESS 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
• Product kit formation in compliance with Federal Laws 44-FL and 223-FL
• Full registration process support
• Handling of regulatory remarks
• Obtaining registration certificate

Premium Services:

• Market analysis provision before registration
• Year-long consultative support for registration certificate holder
• Medical device manufacturer trademark protection (discussed before registration)
• Development of production and packaging processes for medical devices

BUSINESS Package Features

• Comprehensive Solution: all necessary services in one package
• In-depth Analysis: preliminary market analysis
• Legal Protection: trademark registration support
• Production Optimization: production process development
• Long-term Support: one-year consultative support

Service Features

• Customized Approach: strategy development tailored to your product specifics
• Professional Support: control of all registration stages
• Expert Assistance: consultations at all work stages
• Document Support: complete documentation set in electronic and paper formats

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

Choose the BUSINESS package for the most efficient registration of your medical device with full support at all stages!

BUSINESS registration 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
• Formation of a set of products for the requirements of 44 and 223 FZ
• Collecting a complete set of dossiers for transmission to the Customer in electronic and paper form.
• Providing market analytics (before registering an account)
• Consulting support of the RU holder throughout the year.
• Trademark protection of the manufacturer (discussed before registration)
• Development of production processes for packaging and production of MI