Roszdravnadzor: the effectiveness and quality of medical devices is under strict government control

The powers of the Federal Service for Surveillance in Health Care (Roszdravnadzor) include the registration of medical devices and control of their circulation in Russia.The comprehensive system of government control established by Roszdravnadzor is based on the most efficient and up-to-date approaches developed in co-operation with the International Medical Device Regulators Forum (IMDRF).

There has presently been a qualitative change in the procedure for the state registration of medical devices in this country; a nomenclature of medical devices has been developed and harmonised on the basis of the Global Medical Device Nomenclature (GMDN); a system has been introduced to monitor the safety of medical devices; the punishment has been made more severe (up to criminal liability) for manufacturing and selling counterfeit, fake, or unregistered medical devices as well as for sellers giving false information about the properties and purpose of a device; up-to-date laboratories have been set up at expert institutions run by Roszdravnadzor.

All this has an effect on the safety of citizens in this country: only quality, safe, and effective medical devices which have passed a strictest multistage system of expert assessment (including clinical trials) are allowed to the market.

The government control measures taken by Roszdravnadzor in 2015 resulted in preventing the circulation of about 5 million unregistered, low-grade, fake, or counterfeit medical devices (it was 1,961,164 in 2016).

The trials and expert examinations conducted in 2015 revealed that 85% of the checked samples of medical devices failed to meet the established quality and safety requirements (80% in 2014). Eighteen per cent of them, if used, could have done considerable harm to the life and health of citizens.

The purpose of Roszdravnadzor is to minimise this figure. To fulfil this purpose the system of government control is constantly improved. Thus the development of a regulatory framework for a “common” market of medical devices has virtually been completed now as part of implementing the Eurasian Economic Union treaty. Common regulation of the medical device market in the Union member states suggests the use of the most advanced practices, which will undoubtedly have a most positive effect on the quality and effectiveness of medical devices circulating in Russia.

The government spares no effort to provide patients with quality and safe medical products. Citizens must nonetheless share the responsibility. In this connection, Roszdravnadzor recommends making certain before using any medical device that it is registered in Russia: this information is available to the public on the agency’s official website. Besides, a medical device must be bought on the doctor’s recommendation and only in immobile points of sale such as a pharmacy or specialist shop.