Medical Device Import Registration (Government Decree № 1684) Pro *registration period is up to 10 months

Professional Medical Device Registration: Extended Service Package

Introducing the «Medical Device Import Registration (Government Decree № 1684) Pro» Package

Elibrium Company is pleased to offer an expanded range of services for medical device registration, including all necessary procedures for successful market entry into the Russian Federation.

Full Range of Services

Basic Registration Procedures:

• Development of technical file extract

• Creation of professional operating manual

• Execution of registration power of attorney

• Preparation of complete photographic materials package

• Formation of regulatory requirements documentation

• Organization of official product import to the Russian Federation

Comprehensive Testing Support:

• Full technical testing support

• Organization of toxicological research

• Conducting clinical trials

• Dossier compilation and submission to Roszdravnadzor via elk.Roszdravnadzor

• Professional registration process support

• Effective handling of regulatory remarks

• Obtaining registration certificate

• Transfer of completed dossier to client

Additional Services:

• Professional translation of documentation into Russian

• Notarization of all required documents

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

Advantages of the Extended Package

• Maximum Комплектация: all necessary services in one package

• Time Efficiency: no need to engage additional contractors

• Quality Assurance: single responsible executor at all stages

• Compliance: full adherence to all Russian Federation regulations

• Successful Registration: professional approach to each process stage

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.

Why Choose Us?

• Expert Level: team of certified specialists with extensive experience

• Customized Approach: development of unique strategy for each client

• Full Support: from documentation to obtaining registration certificate

• Timely Execution: guaranteed completion within agreed deadlines

Contact Us

Ready to help your medical device successfully enter the Russian market!

IMPORT Pro registration includes the following services:

• 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 FZ