Marketing authorization of medical devices
Our services for the registration of medical devices include:
Registering medical devices made by domestic and foreign manufacturers
Registering amendments to medical device dossiers
Change in market authorization holder, place of manufacture, device name
Arranging and monitoring medical and clinical trials of medical devices
Arranging and monitoring technical and toxicology testing
Registration of medical devices
A medical device is any instrument, apparatus, device, equipment, material, or other product used for medicinal purposes alone or in combination with another medical device, as well as with other accessories required for these products to be used for their intended purpose, including special software, and designed by the manufacturer for the prevention, diagnosis, treatment, and medical rehabilitation of diseases; monitoring of the condition of the human body; medical research; the restoration, replacement, or alteration of anatomical structures or physiological functions of the body; or preventing or terminating pregnancy, and the functional purpose of which is not achieved through pharmacological, immunological, genetic, or metabolic effects on the human body.
Under Russian law, state registration is required for all medical devices intended for medical use in the Russian Federation.
Since March 1, 2025, the RF Government Resolution of November 30, 2024 No. 1684 “On approval of the Rules for state registration of medical devices” has entered into force. What has changed? Overview of the new rules for registration of medical devices
We offer a comprehensive solution for the task of medical device registration
I
Preliminary evaluation of dossier
- Perform an initial evaluation of the dossier and provide client consultation
- Evaluate the completeness of the materials submitted and their compliance with the registering agency requirements
- Calculate the cost of registration and come to an agreement with the client
II
Development of documents
- Revision of manufacturer’s documentation in order to bring it into compliance with the requirements of current regulatory legal acts (extract from technical documentation, Instructions for use)
III
Conducting tests
- Import of samples for testing (for medical devices of foreign manufacture)
- Conducting technical and toxicological tests, tests for the purpose of approving the type of measuring instruments (if necessary), organizing and conducting clinical trials in the form of data assessment
IV
Submitting for registration
- Electronic submission of a dossier and application to the RZN for registration of a medical device in accordance with PP 1684
V
Dossier examination
- Monitoring dossier examination, responses to regulator requests
VI
Obtaining a registration certificate
If it is necessary to conduct clinical trials involving humans
- we will prepare a package of documents to obtain approval from the Ethics Committee
- we will organize medical trials, including multicenter medical trials
Online consultation on marketing authorization of medical devices
If you have any questions, or would like to contact us for any reason, please use the form on the right. We do our best to respond as quickly as possible. Please, enter your real telephone number and we will call you back soon. Also, if you would like us to call you back with an answer to your specific queries, then please, describe give us full details in this message. We are looking forward to hearing from you!
Contact information
Line №1: +7 (495) 120-11-64
Line №2: +7 (495) 120-11-59
Line №3: +7 (903) 748-60-35 (English-speaking consultant)
Line №4: +7 (958) 561-33-87
WhatsApp: +7 (958) 561-33-87