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The Ministry of Russian Health proposes new indicators of the risk of violations in the circulation of medical devices
- By Newsdesk
- Russia
- Jun 23, 2023
The Ministry of Health of the Russian Federation has put forward a revised set of indicators to assess the risk of non-compliance with the regulations of Roszdravnadzor, which govern the circulation of medical devices. The draft order has been published on the portal for draft regulatory legal acts, and it is intended to replace the previous order, No. 503n, issued on May 24, 2021.
The explanatory note accompanying the document explains that these risk indicators are meant to determine compliance or deviation from the control parameters, indicating the likelihood of violations and the potential risk of harm to legally protected values. It is important to note that these indicators themselves do not constitute violations of mandatory requirements.
The proposed update introduces three new indicators, while retaining the existing one from the current document. The existing indicator pertains to a twofold or greater increase in the number of documents on the results of clinical trials of medical products issued by a medical organization within a calendar year compared to the previous year.
Once the bill is adopted, Roszdravnadzor will have grounds to inspect licensees responsible for medical device maintenance in two scenarios. Firstly, when they receive an application for license issuance or renewal, specifying tools and equipment data (such as brand, modification, factory/serial number, and manufacturer) that were previously claimed by another applicant (licensee) in a different region of the Russian Federation. However, this does not apply to cases where maintenance is planned for the organization's own use or for medical products with a low potential risk of use.
Secondly, the use of the same premises by two different licensees for medical device maintenance will be considered a risk indicator.
Lastly, employing an individual who has entered into an employment contract with another licensee in a different region of the Russian Federation during a calendar year will be a prerequisite for inspecting an organization.