Roszdravnadzor, the authority responsible for medical devices and other healthcare products allowed to be marketed and used in the Russian Federation, has published a regulation on state supervision over the circulation of medical devices. The appropriate resolution adopted by the Government of the Russian Federation also states that Roszdravnadzor should undertake planned and unplanned inspections to assess compliance of entities involved in operations with medical devices with respective regulatory requirements. The new procedure entered into force on July 1, 2021.
The new regulation establishes the rules procedures related to state control (supervision) over the circulation of medical devices (the regulation uses the term “state control”).
The scope of the state control covers:
- Compliance with mandatory requirements for circulation of medical devices including but not limited to:
- Requirements for technical, toxicological, and clinical examinations, manufacturing, importation, storing, transportation, distribution, deployment, use, technical maintenance, and repair;
- Requirements for quality, safety, and effectiveness of medical devices allowed to be marketed and used in the Russian Federation;
- Compliance with licensing requirements related to the activities on manufacturing and maintenance of medical devices and equipment (except the cases when such activities are undertaken to meet the internal needs of the institution);
- Compliance with requirements on providing information related to medical devices;
- Fulfillment of the decision taken based on the results of the inspection.
State control should be carried out by the Federal Services for Surveillance in Healthcare (Roszdravnadzor) and its territorial bodies. Apart from specific rules related to medical devices, state control in the sphere of medical devices should be undertaken by the general rules on state supervision and control.
The objects of the state control include the activities in the sphere of medical devices, results of such activities, as well as buildings and equipment used to undertake them.
The regulation described herein also pays special attention to risks associated with medical devices and the way they should be managed. In particular, it is stated that state control should be undertaken based on the management of risks associated with causing harm. According to the regulation, the following categories apply:
- Significant risk;
- Medium risk;
- Moderate risk;
- Low risk.
The determination of the applicable risk should be based on specific criteria related to the activities undertaken. The particular criteria to be applied are prescribed by the regulation itself.
It is also important to mention that Roszdravnadzor may review the risk category within 5 business days from the date the new information was received.
The above mentioned risk categorization should be also applied for determining the frequency of regular inspections the entities should be subject to. According to the guidance, the following approach should be applied:
According to the guidance, the regulating authority should also undertake preventive measures. In particular, the appropriate harm prevention program should be developed by Roszdravnadzor and published on its official website on an annual basis. Preventive actions to be taken by the authority include, inter alia, the following ones:
- Summarizing the practice of applying regulations;
- Advising and consulting;
- Preventive inspection.
Should the authority have information regarding a potential violation of mandatory requirements, or sights of such violation, or in the absence of confirmation that such violation resulted in the harm caused, the authority is entitled to issue a warning to the entity in question and required to take measures necessary to ensure compliance with the requirements. The entity which has received such a warning may provide an objection, which should be provided no later than 15 days from the date the warning was received. An objection submitted by the entity should contain the following details:
- Name of the legal entity;
- Tax Identification Number;
- Date and number of the warning issued by the authority;
- Justified position about actions described in the warning as actions that could potentially result in violation of mandatory requirements.
Such an objection could be accompanied by the documents reasonably necessary to demonstrate that the objection is justified. An objection could be provided in paper or electronic form.
The authority will review the objection received and provide its response within 20 business days from the date the objection was received.
Advising and Consulting
The regulation also states that to assist medical device manufacturers and other parties involved in operations with medical devices in interpreting and applying respective rules and requirements, the regulating authority may provide additional advice and consultations. Such consultations are provided free of charge. Under the general rule, recommendations could be provided via phone, email, or by using videoconferencing tools. However, should it be impossible to provide a comprehensive response immediately, or should it be explicitly requested by the applicant, the authority may provide its response in writing.
The regulation also describes the approach to be applied by the authority to make the processing of requests more efficient. In particular, should more than 5 similar requests be received, the authority should prepare and publish official clarifications on its website.
It is also important to mention that the advice requested should be related to general regulatory requirements, but could not address the particular actions taken by the authority about the inspected entity, or the aspects related to a particular inspection. However, an entity subject to inspection may ask for additional consultation and advice in the course of an inspection.
Under the general rule, the authority should advise on:
- Existence and/or content of mandatory requirements;
- Periodicity and procedure of undertaking control (supervisory) measures;
- The procedure of fulfillment of mandatory requirements;
- Fulfillment of the requirement requested by the authority based on the results of the inspection.
Advice related to the last point of the listed hereinabove should be performed in writing.
The document provides such a specific form of interaction between the authority and responsible entity as a “preventive visit”. In the course of such a visit, a representative of the regulating authority informs about mandatory requirements the entity in question should follow due to the specific nature of its activity, applicable risk criteria, as well as recommended way of reduction of risk category, and also about the content and intensity of control (supervisory) measures this entity should be subject to based on its current risk category.
In summary, the present regulation published by Roszdravnadzor prescribes the way the authority will undertake its supervisory activities about entities involved in operations with medical devices. The document describes in detail the procedures to be undertaken by the authority and outlines the obligations of medical device manufacturers and other parties involved.
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