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;
- Replacing marketing authorisations issued before January 1, 2013 in accordance with Russian Federation Government Decree No. 1416 dated December 27, 2012, On the Approval of Rules for Public Registration of Medical Devices.
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.
We offer a comprehensive solution for the task of medical device registration.
- 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
- Obtain a permit to import test samples (for medical devices made by foreign manufacturers)
- Conduct technical and toxicology studies, as well as tests for approval of measuring instrument type (if applicable)
- Compile and finalize dossier in accordance with regulatory requirements (see the Regulatory Framework section)
- Register on the Roszdravnadzor portal
- Submit the dossier to Roszdravnadzor
- Submit additional materials, respond to reviewer questions, and monitor the pre-registration evaluation process
- Obtain referral to medical trials
- Organize and monitor medical trials
- Revise, finalize, approve report
- Submit report to Roszdravnadzor
List of documents required for medical device registration
for Medical Device Registration
Russian Federation Government Decree No. 1416 dated December 27, 2012, On the Approval of Rules for Public Registration of Medical Devices
Administrative Regulation of the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing regarding the provision of government services for the state registration of medical devices
Medical devices circulation in Russia
Presentation. Medical devices circulation in Russia.
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Telephone №1: +7 (495) 120-11-64
Telephone №2: +7 (495) 120-11-59
Telephone №3: +7 (903) 748-60-35 (English — speaking consultant)