Roszdravnadzor, the Russian regulating authority in the sphere of healthcare products, has published a recently adopted regulation dedicated to state supervision in the sphere of activities related to medical devices. In particular, the document establishes the regulatory requirements for various actions the authority is entitled to undertake when assessing compliance with existing legislation prescribing the way medical devices should be manufactured, stored, and distributed to ensure their continued safety and effectiveness. Among other aspects, the regulation covers such matters as:

  • Decisions the authority may take based on the results of supervisory actions taken;
  • Appealing the decisions made by the authority in a pre-trial procedure;
  • Criteria the authority applies when determining whether the entity in question should be subject to state control and supervision.

Regulatory Decisions

Should it be confirmed by the inspection that there are no violations of applicable regulations, the appropriate entry should be added to the register of control (supervisory) actions. At the same time, an inspector may provide additional recommendations regarding compliance, as well as undertake any other activities aimed at the prevention of new risks. 

In certain cases, Roszdravnadzor publishes a respective notice at its official website to communicate important safety-related information to all the parties involved in operations with medical devices. This procedure should be applied in case the authority:

  • Identifies a batch of medical devices that are of poor quality; 
  • Identifies an unregistered medical device;
  • Identifies a falsified medical device;
  • Initiates a withdrawal of a batch of medical devices creating additional risk to public health due to their low quality;
  • Initiates the suspension of the use of a medical device due to confirmed facts and circumstances resulting in additional risk to public health when such a device is used for its intended purpose;
  • Initiates a withdrawal of a medical device from the market since its safety and quality haven’t been duly confirmed;
  • Permits a renewal of use of a medical device upon successful confirmation of its safety and effectiveness. 

The authority should decide to allow medical devices for further use in case the facts and circumstances creating concerns regarding their safety and effectiveness haven’t been confirmed. 

The appropriate notification would be provided to the entity responsible for a medical device in paper form. It could be either provided directly to its authorized representative or sent via registered mail.

Should the authority identify that a medical device creates hazards for the health and safety of patients and healthcare professionals, the authority could decide to initiate a withdrawal of such a product. 

Irrespective of the decision taken, information about it should be submitted to the state register of control (supervisory) actions no later than 5 business days from the date the decision has been adopted.


Appeal Procedure 

Should an entity responsible for a medical device in question disagree with the decision taken by the authority, it may submit an appeal in electronic format via the state portal. Such an appeal should be signed with a digital signature. Once an appeal has been filed, the authority should review it within 20 business days from the date it was received. 

The regulation further describes the way an appeal would be reviewed depending on the level of the regulatory agency whose actions are objected to. 


Risk Categorization Criteria 

The regulation also provides the requirements to be considered by Roszdravnadzor when determining the risk category an entity conducting operations with medical devices should be assigned to. According to the regulation, such a determination should be based on the potential severance of the negative consequences in case of failure to comply with the applicable Russian regulatory requirements. The decision of the authority should be based on the information regarding the particular entity, stored in the respective register of entities allowed to manufacture medical devices, conduct clinical trials, or carry out any other activity in the sphere of medical devices. 

The aforementioned criteria should be applied based on the particular type of activity in the sphere of medical devices the authority in question undertakes, namely:

  1. Manufacturing (producing) medical devices;
  2. Application, use of medical devices in the course of medical activity, conducting clinical trials;
  3. Technical maintenance (deployment, control, periodic maintenance) of medical equipment;
  4. Distribution of medical devices;
  5. Importing of medical devices to the country or exporting them outside;
  6. Destroying medical devices;
  7. Transportation;
  8. Storing;
  9. Conducting trials (examinations), other than clinical trials. 

When indicating the applicable risk, the authority applies the numbered scale (with risk value K) which provides the following:

  1. If the risk value K is more than 70 points – significant risk;
  2. If the risk value K is from 53 to 70 points – medium risk;
  3. If the risk value K is from 36 to 52 points – moderate risk;
  4. If the risk value K is less than 36 points – low risk. 

The entities engaged only in importing, exporting, storing and transportation of medical devices are to be assigned to the low-risk category. 

The risk value K should be calculated by the appropriate formula provided in the regulation by summarizing the points indicated in respective tables for various spheres of state control. Should some of the criteria appear to be not applicable, the value to be indicated should be 0. 

The regulation also provides the aforementioned list of criteria the authority will apply when determining the risk-based category. The criteria contained therein include, inter alia, the following ones: 

  1. The class of medical devices the entity deals with;
  2. The number of types of medical devices;
  3. State registration as an entity undertaking operations with medical devices;
  4. The number of sites (facilities) where the activities are carried out;
  5. The date of actualization of the registration dossier.

In the case of entities engaged in the use, clinical trials, and examination of medical devices, the list of applicable criteria would be slightly different to cover the respective aspects. In particular, it would address the type of activity, type of medical activity, and the number of clinical trials undertaken. 

Specific criteria should be also applied in the case of entities involved in the technical maintenance of medical equipment. In such a case, the particular criteria to be considered would include the type of activity and the number of facilities.

As further prescribed by the regulation, specific criteria should be applied for all other types of activities in the sphere of medical devices, such as distribution or importing and exporting. 

In summary, the present regulation describes in detail the way the control (supervisory) activities should be performed by the authority to assess whether all the parties involved in operations with medical devices are fully compliant with the applicable Russian regulatory requirements. The document outlines the actions the authority may take in case of any non-compliances identified, and also highlights other important aspects to be considered in this regard. 



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