Russia. Draft departmental order “On Approving the Regulations on Organizing the Hi-Tech Medical Care Provision”

The Ministry for Industry and Trade of Russia has prepared a draft Government Resolution On Establishing a Ban on Access for Goods (Certain Types of Medical Devices) Originating from Foreign States, for the Purposes of Public Procurement for State and Municipal Needs for the Purpose of Protecting the Domestic Market of the Russian Federation.

The draft Resolution is still pending approval, inter alia, by the Federal Antimonopoly Service and the Ministry for Economic Development in respect of the price-setting and future impact upon the competition environment. In addition, according to the rules, any state customer procuring medical devices and establishing the starting maximal price should also consider the historical procurement data.

This should ensure ruling out price manipulations. Enterprises whose products comply with GOST ISO 13485-2011 standard will be allowed to participate in public procurement of medical devices.

Source: KPMG-Russia