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Accelerated state registration procedure of low-risk medical devices in Russia
Dear Colleagues,
The Government of the Russian Federation on the basis of Decree No. 299 of March 18, 2020, has approved a simplified procedure for state registration of low-risk medical devices. This measure has been taken to prevent the spread of infectious diseases and allows providing the market with personal protective equipment within a short time.
In accordance with the new rules, the list of documents required to be submitted for state registration of a medical device has been greatly reduced as well as the time for the registration process and consideration of the registration dossier. These rules apply to the following products
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Medical gloves
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Medical gowns
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Face masks/respirators
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Overshoes/boot covers
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Surgical suits and other products
The full list of products is provided in Decree No. 299 (see the file attached).
Let us briefly turn to the procedure itself and possible nuances.
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The applicant should prepare an initial package of documents including five basic ones, such as technical and operational documentation, and images of a general view of a medical device;
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The applicant should submit a package of documents to Roszdravnadzor;
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The body should assess the completeness and reliability of the information provided within three working days;
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Within 150 working days, the applicant should carry out toxicological, technical and clinical studies, finalize the technical and operational files and submit the corresponding data to Roszdravnadzor;
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The body should assess the completeness and reliability of the information, and then send it to the expert organization, or notify the applicant of the need to eliminate all the faults noted in the remarks within 30 calendar days;
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The expert organization should conduct an examination, as a result of which it should notify of a positive conclusion, or send remarks on the faults that must be eliminated within 50 calendar days;
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An applicant should be issued with a registration certificate.
What is worth paying special attention to?
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Failure to comply with the time frame for the elimination of faults noted in the remarks causes the return of the registration dossier;
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Only the results of technical tests by All-Russian Scientific Research Institute of Medical Equipment of Federal Service on Surveillance in Healthcare are recognized;
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Samples import, as well as technical and operational documentation drawing up, should be prepared in advance in order to avoid the risk of wasting time.
These are the main aspects of the Decree that we would like to draw your attention to.
It is possible that under pandemic conditions, the Government will expand the list of products specified in the Decree.
The MedExpert team will keep you informed of all changes in the regulatory sphere.
If you have any questions, we will be eager to answer them.
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