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Registration of in vitro medical devices is a mandatory procedure required by the legislation of the Russian Federation, which confirms the safety and efficacy of medical devices intended for diagnostic testing outside a living organism.
Registration of In Vitro Diagnostic Medical Devices
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In vitro diagnostic (IVD) medical devices encompass a wide range of instruments, reagents, and systems designed to analyze biological samples to obtain information about a patient's health condition. IVDs help detect various diseases, from infectious to oncological. They enable large-scale screening for early disease detection, monitor treatment effectiveness, and are used to determine tissue compatibility in transplantation.
When seeking assistance from the experts at RZN Expert, you can be confident in the proper preparation of all necessary documents and the successful completion of all stages of the registration process.
Key aspects of in vitro device registration
The IVD registration process is complex and multi-stage, requiring thorough preparation, compliance with all established requirements, and in-depth knowledge of legislation and the specifics of medical devices.
Strict requirements apply to the documentation of in vitro devices. It must include a detailed description of the device, its operating principle, characteristics, and test results. For registration, it is necessary to provide an extensive set of documents confirming the device's compliance with all established norms and standards.
Technical Documentation
01
IVDs are classified according to the level of potential risk to human health. The scope of required research and testing depends on the risk class.
Risk Classification
02
In some cases, clinical trials may be required to confirm the effectiveness and safety of the device.
Clinical trials
03
The registration dossier undergoes a thorough evaluation, including an assessment of the device's quality, safety, and efficacy.
Comprehensive evaluation
04
After registration, in vitro medical devices must be labeled with a market circulation mark.
Mandatory labeling
05
Even after obtaining the registration certificate, the manufacturer is required to conduct ongoing monitoring of the device's safety on the market.
Ongoing monitoring
06
The timeline for IVD registration may vary depending on the complexity of the device, the volume and completeness of the submitted documentation, and other factors. In practice, the medical device registration process can take anywhere from several months to a year.
Procedure timelines
07
Other services within the scope of medical device registration.
RZN Expert provides services for QMS analysis and implementation in compliance with ISO 13485 requirements for medical devices. We conduct an in-depth assessment of your processes, identify vulnerabilities, and develop tailored solutions for improvement.
Our experts will help you not only obtain ISO 13485 certification but also implement safe and effective procedures that meet global standards. We ensure full compliance with all medical device quality management system requirements, opening new opportunities for international market entry and increasing trust in your products.
RZN Expert also offers a full range of services for medical device registration with Roszdravnadzor.
Our experts will help you not only obtain ISO 13485 certification but also implement safe and effective procedures that meet global standards. We ensure full compliance with all medical device quality management system requirements, opening new opportunities for international market entry and increasing trust in your products.
RZN Expert also offers a full range of services for medical device registration with Roszdravnadzor.
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