Dear Colleagues,

This is my usual monthly review for October with a selection of the latest medical device regulation changes across Russia, the Eurasian Union, and other CIS countries.

1. Updates on Eurasian Medical Device Harmonisation


Several interesting small updates happened in the development of Eurasian medical device harmonisation in October 2018:

• At the beginning of October 2018, the competent authorities of Kazakhstan officially suggested to the Eurasian Economic Commission (EEC) to prolong until 2025 the transition deadline from local to the Eurasian medical device registration system (you may recall that current Eurasian regulations set this deadline as 2021). Experts from the EEC announced that the possibility of shifting the transition period is currently being discussed, however, a final decision on the deadline is not yet clear;
• A very convenient update is the creation of a separate section on Eurasian medical device regulations on the website of the Eurasian Commission (link to the section). The section summarizes a list of Eurasian medical device regulations, a description of approval procedures according to medical device classification, registration documents checklists, a list of competent authorities and accredited laboratories, a database of registered medical devices, and safety monitoring for the Eurasian Union. Materials are currently provided in Russian;
• Another October update is a draft of the methodical guidelines for medical device registration expertise for Eurasian registration, published (link in Russian) by the EEC. The document is intended to establish uniform approaches to the examination of medical devices and the unification of expert requirements across competent authorities of Eurasian member states for the assessment of the content of the registration dossier.

2. Tightening of Responsibility for Online Medical Product Violations in Russia

In October 2018, the Russian Duma introduced a draft law (link in Russian) that stipulates a tightening of administrative and criminal responsibility for the circulation of counterfeit, poor-quality, and unregistered medicines and medical devices through the internet.

The responsibility for the distribution of falsified, poor-quality, and unregistered medical products was introduced in Russia in 2015, however, the bill emphasised the responsibility for the violations of the distribution of medical products via the internet.

The document meets the requirements of the international MEDICRIME Convention against counterfeit medical products and similar crimes involving threats to public health, which was signed by Russia in 2011 and ratified in 2018.

3. Possible Regulatory Exclusions for Certain Medical Devices in Ukraine

On 1^st October 2018, the Ministry of Health of Ukraine published a draft regulation (link in Ukrainian) that suggested authorising the importation of medical devices and in vitro diagnostics that are necessary in cases of emergency, the implementation of international technical assistance programmes, and some other conditions without the need for established approval/conformity assessment procedures. The document suggests a simplified ten-day application procedure for getting authorisation for the importation of specific batches of medical devices which meet the above-mentioned criteria.