Post-registration clinical monitoring

Regulatory framework

In accordance with Order No. 1113n of the Russian Ministry of Health dated October 19, 2020, for medical devices classified as potential risk class 3, as well as medical devices implanted in the human body classified as potential risk class 26, the manufacturer of the medical device (or its authorized representative) is required to monitor the safety and clinical efficiency of the device after its registration (hereinafter, clinical monitoring) and submit clinical monitoring reports to the Service annually during three years.

Clinical monitoring reports are submitted by the manufacturer of the medical device (or its authorized representative) to the Service no later than February 1 of the year following the year in which the registration certificate was issued.

Our team helps:

Define the goals and objectives of clinical monitoring;

Develop a clinical monitoring scheme, including justification of the methods (techniques) for obtaining and statistically analyzing clinical data, selection of the study population, inclusion (exclusion) criteria, and the minimum number
of subjects in the study group;

To define criteria for assessing clinical efficacy and safety;

Develop questionnaires and client cards as a way of obtaining clinical data from medical institutions;

Prepare documents for submission to Roszdravnadzor.

Need a consultation?

Request a free consultation on the registration procedure  and ask all your questions.