A number of normative acts and certain provisions containing requirements for control over circulation of medical devices, recognized as void and will cease to operate from 1 January 2021. This decree was signed by Prime Minister Mikhail Mishustin.
“The list of cancelled documents – individual paragraphs and sections of the regulations on approval of the unified list of products subject to mandatory certification on approval of provision on licensing of activities for production and servicing of medical devices, on combating trafficking in counterfeit products”, – is reported on the government website.
In addition, cancelled 11 orders of Ministry of health, including regulating equipment car kits and kits for medical care.
These acts or contain obsolete requirements, or their provisions are duplicated in the current legislation.
Revision of norms of the Russian legislation, which the government is pursuing together with the expert community and business representatives, is carried out in the framework of the “regulatory guillotine”. It provides for the abolition of unnecessary or outdated regulatory requirements to reduce the regulatory burden in key sectors of the economy, stress in the Cabinet.