Timeframe and order of administrative procedures and administrative actions performed by Roszdravnadzor are regulated by the Administrative Regulation of the Federal Service on surveillance in Healthcare in Terms of Provision of the State Service of State Registration of Medical Devices approved by the Order of the Ministry of Health of the Russian Federation dated 14.10.2013 № 737n.
Roszdravnadzor shall perform state registration of medical devices within 50 working days following the date the decision to start state registration of medical devices has been made.
The duration of clinical trials of medical devices is not included into this 50 day’ period.
An expert institution shall provide expert evaluation of quality, efficacy and safety of a medical device in two stages in accordance with the procedure established by the Ministry of Health of the Russian Federation:
1) during Stage I an application for registration and documents listed in paragraph 10 of the Rules are examined in order to determine the possibility (impossibility) of conducting clinical trials of a medical device;
2) during the Stage II expert evaluation of comprehensiveness and results of conducted technical, toxicological, clinical trials as well as the trails intended to approve the type of measuring tools (with respect to medical devices referred to measuring tools in the field of state regulation of the uniformity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation) (hereinafter referred to as the expertise of comprehensiveness and results of trials and studies) is performed.
There is a new feature that allows an applicant to present any missing materials and information (including possibility to eliminate any insufficiencies revealed during the expertise) during any stage of the expert evaluation of quality, efficacy and safety of medical devices for the purposes of the state registration.
Upon completion of Stage I experts determine possibility/impossibility of conducting clinical trials of medical devices or impossibility of state registration of a medical device (for the devices referred to the 1st class of potential risk of medical devices (except for medical devices referred to measuring tools in the field of government regulation of the uniformity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation).
Clinical trials require a permission to conduct clinical trials, issued by Roszdravnadzor.
Clinical trials of a medical device are held in medical institutions included into the List of Medical Institutions for Clinical Trials, approved by Roszdravnadzor.
Upon completion of Clinical trials an applicant submits an application to resume state registration of the medical device and the results of medical device clinical trials to Roszdravnadzor
During Stage II of the expert evaluation of quality, efficacy and safety of a medical device an expert institution carries out the examination of completeness and results of the conducted trials and studies and sends the assessment based on the results of the evaluation of quality, efficacy and safety of a medical device to the registration authorities
In case the assesment received from an expert institution on the results of the expert evaluation of quality, efficacy and safety of a medical device states that quality and (or) efficacy and (or) safety of a medical device subject to the state registration haven’t been confirmed by the data obtained and (or) that the risk of damage to health of individuals and medical workers due to medical device administration exceeds the efficacy of its use, it becomes the base for decision to refuse the state registration of a medical device
Within 1 working day following the date a decision on the state registration of a medical device have been made, Roszdravnadzor enters data on the registered medical device into the State Registry of Medical Devices and Institutions (individual entrepreneurs) manufacturing and producting medical devices.