Medical Devices Registration

The process of medical device registration in Russia is a procedure through which medical devices obtain official approval for sale and use within the country. The process is regulated by the Federal Service for Surveillance in Healthcare (Roszdravnadzor), as well as a number of legislative acts and standards. A key step is checking the compliance of the device with established safety, quality, and efficacy requirements. It is important to note that depending on the risk class of the device, additional requirements may be imposed during the registration process.

Main stages of medical device registration:

Preparation of Documentation:
To register a medical device, a dossier must be prepared, which includes the technical and clinical characteristics of the device, instructions for its use, information about the manufacturer, and other important data. Test results confirming the safety and efficacy of the device may also be required.

Compliance Assessment:
At this stage, the device undergoes technical, toxicological (if necessary), and clinical laboratory tests and checks for compliance with national standards and regulations.

Submission of the Application:
All documents and information are submitted to Roszdravnadzor for consideration. The application may include data on production processes, components, and production capacity.

Clinical (Human) Trials (if necessary):
If the device is classified as in-vitro or high-risk (e.g., implants or medical diagnostic equipment) and has not undergone clinical trials in other jurisdictions, clinical trials may be required to confirm its safety and efficacy.

Issuance of Registration Certificate:
After addressing all corrections suggested by the regulatory body, if any, Roszdravnadzor issues a registration certificate, granting the right to sell and use the medical device in the Russian Federation.

Post-Registration Activities:
After registration, the medical device may be subject to additional inspections and audits to confirm its safety during operation.