Dear Fellow Colleagues,
Welcome to my monthly newsletter with my selection of highlights in medical device regulations in Russia. Here are the most important updates for January.
- Road map to Development of Competition in Public Health Sector
On the 12th January 2018, the Russian Government published resolution #№9-р (link in Russian) with a roadmap to “developing competition in healthcare” for 2018–2019.
The published document contains a list of suggested strategic measures to develop competition in the public market for medicines, medical devices, healthcare services, and biologically active supplements in Russia, in the coming years.
A significant part of this document is devoted to changes in the regulation of medical devices expected in the next two years. Thus, among others, the following measures were suggested:
- Development of the concept of medical devices of the “open” and “closed” types in terms of the possibility of using consumables or reagents from other manufacturers and the duty of the state and municipal customers to purchase medical products of an “open” type.
- Development of the concept of the interchangeability of medical devices.
- Introduction of a ban for manufacturers to set restrictions on the possibility of using consumables/reagents from other manufacturers.
- Inclusion in the technical documentation for medical device information on the period of operation costs of technical maintenance and repair, costs of training medical personnel for the rules of application, and operation of the medical device.
The document also mentions a number of measures to improve and develop the regulation on the procedure of state and municipal procurement of medical products. The full text of the road map is available on the website of the Government of the Russian Federation.
- Checklists and Year Plan for Inspections
On the 26th January 2018, the Russian medical device regulator, Roszdravnadzor, published the approved forms of checklists (lists of control questions) that are used by the regulator during routine control inspections/audits of medical device manufacturers and other organisations involved in the turnover of medical devices in Russia.
In total, seven checklists have been published for the monitoring at each stage of the medical device lifecycle (control of pre-registration testing, clinical trials, usage and application in clinics, control of medical device manufacturers and its authorised representatives, technical maintenance, transportation, and storage). The checklists clarify whether organisations are complying with the mandatory requirements set by Russian medical device regulations and standards; they could also be a useful tool for audit preparation.
The list of organisations planned for inspection by Roszdravnadzor in 2018 has been published by the regulator in the beginning of January.
- Amendments to Regulation of Medical Products Containing Alcohol
On the 1st January 2018, article #14 of the Russian federal law #171 (link in Russian), the “regulation of turnover of ethyl alcohol, alcoholic, and alcohol-containing products” came into force. According to the updated regulations, Russian companies carrying out the production, manufacturing, and/or turnover of medical products containing alcohol exceeding 200 decilitres per year are obliged to register and declare this volume of alcohol-containing medical devices in accordance with the established procedure. The regulation defines an alcohol-containing medical device as “medical products in a liquid form of release containing a pharmaceutical substance of ethyl alcohol.”
Another amendment to this federal law was enforced in late December 2017 and establishes that until the 1st July 2018, non-declaring of this information by a company is not considered a violation.
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