Registration of medical devices

State registration of medical devices (MD) is a compulsory procedure aimed at confirming the compliance of particular medical devices to safety requirements. All medical devices to be distributed and used in Russia, of both domestic and foreign manufacture, are subject to registration. Registration of medical devices is carried out as consistent with the Rules of […]

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Measuring instruments registration

Measuring instruments used in the areas falling under legal control (trade, medicine, environmental protection, the geodetic and cartographical sphere, defense and safety of the state, etc.), must go through measuring device type statement procedure in Federal agency on technical regulation and metrology (Rosstandart) with the subsequent entering into the uniform state register of measuring instruments. […]

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Carrying out tests

Testing may be conducted for various purposes: To register a medical device and obtain a Registration Certificate by the Ministry of Health of the Russian Federation. In this case safety and functional characteristics of the device are tested. To put on the Register as a medical measuring device. Besides safety, metrological characteristic of the device […]

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Declaration of Medical Devices

Compliance of medical devices is confirmed by way of declaration. Medical devices are declared according to the RF Government Regulation dated December 1, 2009 N 982 as consistent with the consolidated list of products being confirmed by way of declaration of compliance. This type of declaration is known as GOST P declaration. Moreover, electrical medical […]

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