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When does software become a medical device?
Software is considered a medical product if it has a direct impact on human health.
Software is considered a medical product if it has a direct impact on human health.
Registration of software with AI
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This is especially true for artificial intelligence programs used to:
- disease diagnosis
- Treatment planning, including the creation of individual treatment plans
- Real-time patient monitoring, etc. remotely
- control of medical devices, such as robotic surgical systems.
- disease diagnosis
- Treatment planning, including the creation of individual treatment plans
- Real-time patient monitoring, etc. remotely
- control of medical devices, such as robotic surgical systems.
According to the legislation of the Russian Federation, any software, including with artificial intelligence, which is used for medical purposes must be registered. When developing and registering software, it is also recommended to take into account international standards in the field of medical devices and artificial intelligence.
Registration guarantees that the software has passed the necessary checks, compliance with security requirements, does not violate the rights of consumers, allows to verify the quality and effectiveness of the software.
Features of software registration with AI
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.
The main challenge lies in the objective evaluation of AI algorithms and their impact on diagnostic or treatment outcomes. Even before submitting a medical device registration application, it is necessary to assess the potential risks of the software to the patient and classify it according to the risk level (I, IIa, IIb, III). The more complex the software, the more time will be required for its evaluation.
Complexity of AI algorithm evaluation
01
It is necessary to ensure transparency in the operation of the software algorithms. To achieve this, prepare all technical documentation with a detailed description of the functionality, AI algorithms, and the data on which the software was trained, so that it is possible to explain how the software makes decisions.
Transparency requirements
02
The following will be required:
- Gather evidence that the software operates correctly and meets the stated specifications.
- Provide a description of measures to ensure patient data security and protection against cyberattacks.
- Document the results of clinical studies confirming the efficacy and safety of the software.
Additional studies may be required.
- Gather evidence that the software operates correctly and meets the stated specifications.
- Provide a description of measures to ensure patient data security and protection against cyberattacks.
- Document the results of clinical studies confirming the efficacy and safety of the software.
Additional studies may be required.
Evaluation of the safety and effectiveness of software
03
When developing and implementing AI-based software, it is essential to consider the ethical aspects associated with the use of artificial intelligence in medicine.
Ethical aspects
04
AI technologies are rapidly evolving, so it is essential to be prepared for continuous software improvement and documentation updates.
Technology dynamics
05
The entire process of registering software as a medical device can take from several months to a year or more. The longest stage—the registration period with Roszdravnadzor—can last from 50 to 180 days.
The registration of AI-based software is a lengthy and labor-intensive process, requiring high expertise from developers and a deep understanding of legislation. For successful registration, it is recommended to consult specialists in medical regulation and artificial intelligence.
Our company's experts successfully help clients minimize the risks of registration refusal and accelerate the software registration process for its prompt legal implementation into medical practice.
The registration of AI-based software is a lengthy and labor-intensive process, requiring high expertise from developers and a deep understanding of legislation. For successful registration, it is recommended to consult specialists in medical regulation and artificial intelligence.
Our company's experts successfully help clients minimize the risks of registration refusal and accelerate the software registration process for its prompt legal implementation into medical practice.
Timing of the procedure
06
Other services within the MD 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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