The Ministry of Health will supplement the standard of equipping clinical diagnostic laboratories
The Ministry of Health of the Russian Federation will update the Rules for conducting laboratory tests, approved by order No. 464n of May 18, 2021. The changes will affect the standard for equipping the clinical diagnostic laboratory: the department proposes to expand the list of medical device codes for a wider selection of equipment by clinics, as well as to supplement the regulations with new types of medical devices.
The department proposes to add an analyzer for the determination of hemoglobin IVD in two versions (automatic and semi-automatic) to the standard of equipment of the clinical diagnostic laboratory (express diagnostics) and laboratories of the first and second levels. An automatic semen analyzer will be included in the regulations for equipping laboratories of the second and third levels, and a tube heater will be included in the list of auxiliary equipment.
The new version of the document will update the codes of the types of nomenclature classification of medical devices, taking into account the proposals received by the Ministry of Health of the Russian Federation from manufacturers and suppliers of medical equipment, clinics, as well as in connection with the need to harmonize the Russian classification of medical devices with the global GMDN nomenclature.
In addition, the number of possible codes for one type of equipment will be expanded. “Indication of several types of nomenclature classification for one name of a medical device allows a medical organization to choose a medical device that best meets the needs of a medical organization, including taking into account the availability of Russian-made medical devices on the market,” the explanatory note to the draft order of the Ministry of Health of the Russian Federation says.
The Ministry of Health of the Russian Federation has been developing new rules for conducting laboratory tests for seven years. The department approved them by order No. 464n of May 18, 2021, they entered into force on September 1, 2021 and will be valid until September 1, 2027.