On 1st January 2020, the Federal Law of 02.08.2019 № 265-FZ “On Amendments to the Federal Law” “On Currency Regulation and Currency Control” entered into force in terms of liberalization of restrictions on foreign exchange transactions that are made by residents using accounts (deposits) opened with banks located outside the territory of the Russian Federation and repatriation of funds1.
According to art. 38 of the Law on fundamental healthcare principles the software used for medical purposes has a legal status of medical device. Therefore, market turnover of such software in Russia is allowed only after software is registered before the Federal Service for Surveillance in Healthcare (Roszdravnadzor).
Although the Law on fundamental healthcare principles does not indicate the criteria of software being medical device, breach of this rule may be qualified as an administrative or criminal offense.
A few vague criteria were outlined in the Information letter of Roszdravnadzor dated 30 December 2015 No. 01I-2358, which were widely criticized by healthcare companaies.
On 13 February 2020, Roszdravnadzor enacted the Legal opinion No. 02I-297/20, where new criteria of software being medical device were introduced, in particular:
- Software is a computer program or mobile- or web-app, and
- is not an integral part of another medical device, and
- is designed for medical treatment, and
- is designed to assist in clinical decisions based on automatic interpretation of received healthcare data
The Legal opinion provides for a few examples of software being medical device and cases when software shall not be entitled with this legal status (e.g., information systems of healthcare organization, step counters, calorie counters, plan systems, e-catalogs).
We believe that new rules will eliminate the need to register software that is not aimed at medical treatment.