Categories of Medical devices

Official classifier of medical devices defines their categories by 4 characteristics (Russia Health Ministry Directive #4 of June 6, 2012):

1. By designation (39 positions: therapy, surgery, cardiography etc)

2. By sterilization requirements (5 positions)

3. By type of application( 8 positions: active and non-active devices, implants etc)

4. By medical area (32 positions: cardiology, gynecology etc)

Each medical device must belong to one of the four Risk Classes:

Class 1 - low risk to both individual and public health;
Class 2a - medium risk to individual health and/or low risk to public health;
Class 2b - high risk to individual health and medium risk to public health;
Class 3 - high risk to both individual and public health

If a device is designed to work with other medical devices as a complex, each device must be registered separately.

1. Software developed for a specific medical device. These applications are tested together with the device as part of the registration process.
2. Standalone applications. These are tested independently. They are less expensive to register than a medical device, since they are not subject to toxicological trials. Time wise, however, they may take similar 4-5 months, as there are only a couple of government laboratories authorized to perform such testing.

Risk Class of software for medical devices is the same as of the medical device it is used with.

 

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