Medical Device Import Registration (Government Decree № 1684) Business *registration period is up to 8 months

Medical Device Registration: Premium «Business» Service Package

Comprehensive Solution for Successful Entry into the Russian Market

Elibrium Company offers the most comprehensive package of services for medical device registration — «Medical Device Import Registration (Government Decree № 1684) Business». We take care of all aspects of registration and subsequent support for your product.

Full Range of Registration Services

Basic Documentation and Registration:

• Development of technical file and operating manual

• Execution of all necessary powers of attorney

• Preparation of complete photographic materials package

• Formation of regulatory documentation

• Organization of legal product import

• Full support for all types of testing

• Dossier compilation and submission to Roszdravnadzor

• Registration process support

• Handling of regulatory remarks

• Obtaining registration certificate

Additional Services:

• Professional documentation translation

• Notarization of all documents

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

• Manufacturer trademark protection

• Production process development

• Assignment of personal specialist for communication with foreign manufacturer

• Development of bilingual distribution agreement

Exclusive Advantages of the Package

Annual Support:

• Consultative support for registration certificate holder

• Assistance with all Roszdravnadzor-related issues

• Help in resolving emerging questions

Why Choose Us?

• Comprehensive Approach: all services in one package

• Expert Team: professionals with years of experience

• Customized Approach: adaptation to your product specifics

• Full Support: from registration to market entry

• Guaranteed Results: successful completion of all registration stages

Cost and Terms

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 guarantee successful resolution of all tasks and full compliance with legal requirements.

The registration of the IMPORT Business includes:

• Development of a technical file extract
• Development of the operating manual
• Developing a power of attorney
• Developing a photographic image file
• Development of a file of information about regulatory documentation
• Registration of the official import of a medical device into the Russian Federation
• 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
• Translation of documentation into Russian
• Notarization of documentation
• Formation of a set of products for the requirements of 44 and 223 FL
• 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
• Providing a specialist to interact with a foreign manufacturer.
• Development of a distribution agreement (2-lingual)