Any medical product or device which is being manufactured in Russia or abroad is subject to mandatory registration with the territory of the Russian Federation. Registration is carried out by the Federal Service for Supervision in Healthcare based on the evaluation of registration docket documents confirming the quality, efficiency, and safety of the devices. Rules for state registration of medical devices are set out in Federal Law No. 323-FZ dated 23.11.2011 “On Fundamentals of Health Care in the Russian Federation”.

The registration for medical devices is a multifaceted and complex step-by-step process. Therefore, to obtain a registration certificate successfully and as soon as practicable one definitely needs to involve specialists in this field. Our employees are high-profile, so they guarantee top quality services.

Thus, the service for support of state registration of medical devices includes:

1. Documentation analysis;
2. Development of the Application for state registration;
3. Preparation of technical documentation;
4. Finalization of the operational documentation;
5. Preparation of information on regulatory documentation;
6. Organization of technical tests;
7. Development of clinical laboratory tests design;
8. Organization of clinical laboratory tests;
9. Preparation of a set of documents and making of a registration docket for submission to Roszdravnadzor (Federal Service for Supervision in Healthcare);
10. Obtaining marketing authorization of Roszdravnadzor;

We also provide the following services for foreign-made devices:

11. Translation of documentation for the medical device (executed as a separate document);
12. Registration of the samples import license.