A new order has approved the list of medical devices classified as measuring instruments and defined a new procedure for their testing.
The final version of Order No. 257n of the Ministry of Health dated April 29, 2025 was published on the Government's Legal Acts Portal on June 2, 2025.
This order will come into force on September 1, 2025 and remain valid until September 1, 2031.
The list of medical devices with measuring functions included in Annex 1 of the order contains:
- Medical audiometer
- Medical scales
- Medical dynamometer
- Universal clinical dosimeter for radiation therapy
- Clinical X-ray dosimeter
- Photon radiation dosimeter for workplace monitoring
- Medical devices for respiratory function testing
- Devices for analyzing inhaled and exhaled air (oximeters, capnometers, breathalyzers)
- Trial lens set
- Clinical radiometer
- Medical height meter
- Medical thermometer
- Medical tonometer
- Photometer, spectrophotometer, colorimeter for clinical laboratory diagnostics
- Medical ergometer
For the state registration and market release of these medical devices, type approval testing as measuring instruments is mandatory.
Although the list remains essentially the same as in Order No. 89n dated August 15, 2012, the testing procedure has been significantly revised.
The application form for testing has been expanded and clarified to include:
- Designation of the type of measuring instrument
- Information about the models (brands) of the medical device
- Details on software used for measurement results
- Availability of preliminary test protocols
- Declared metrological and technical characteristics
- Compliance with Section VII “Medical Devices” of the industrial product requirements for classification as Russian-made
To simplify the interaction with the testing organization, it is now allowed to submit test programs, draft type descriptions, and test reports in electronic form.
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