Dear colleagues,

Welcome to my monthly update!

One may note that February 2018 was a fairly quiet month in the regulatory landscape for medical devices in Russia. However there are several recent minor updates which may be of interest:

1. Updated List of Medical Products Taxed at 10% VAT

At the end of January 2018, the Russian government updated resolution # 688 with a list of medical products taxed at the reduced rate of value added tax (VAT) of 10% (link of updated resolution in Russian). An updated consolidated version of the list was aligned with the new national classification of products (enforced since January 2017).

In this context it should be recalled that Russian legislation grants VAT preferences (0% or 10% VAT instead of 18% as a ‘general rule’) for importing and selling most types of medical devices. The list of medical devices taxed at 0% was last updated in November 2017.

2. List of Alcohol-Containing Medical Devices

At the end of January 2018, the draft regulation, ‘on formation of the list of alcohol-containing medical products’ (link in Russian), was published. According to the document, medical devices ‘in a liquid form of release containing the pharmaceutical substance of ethyl alcohol’ should be included in the special list by special commission of the Ministry of Health depending on a number of criteria (volume of consumer packaging, cost and functional purpose of a medical device). The commission is expected to revise the list no more than once a year and no later than 31^st March. It is also expected that medical products included in the list will not be regulated by the Russian Law on State Regulation of Production and Turnover of Ethyl Alcohol and Alcohol-Containing Products, which was amended in January 2018.

3. Weighted Average Prices for Polyvinylchloride Plastics Consumables

On 1^st February 2018, the Russian Ministry of Health of the Russian Federation published a letter (link in Russian) proposing the updated weighted average prices for foreign disposable medical devices made of polyvinyl chloride plastics (PVC).

The weighted average prices are used for calculation of the guaranteed maximum price for state and municipal purchases according to the methodology provided in Order № 759N (link in Russian) by the Ministry of Health and the Ministry of Industry and Trade in October 2017.

A new scheme for the public procurement of consumable medical devices made from PVC was introduced in Russia in August 2017 with significant extension of the previously adopted Resolution No. 102 ‘On Establishing Access Restrictions for Certain Types of Foreign-Made Medical Products to Procurement for State and Municipal Needs’.

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