Kiselev M.V., Consultant of the Department for Organization and Conduct of State Control over the Circulation of Medical Devices of the Department for Organization of State Control and Registration of Medical Devices, KiselevMV@roszdravnadzor.ru

Migeeva M.A., Deputy Head of the Department for Organization of State Control and Registration of Medical Devices, MigeevaMA@roszdravnadzor.ru

For citation: Kiselev M.V., Migeeva M.A. Organization of control purchases of medical devices. – Vestnik Roszdravnadzora. – 2020. – Vol. 2. – P. 36–40. DOI: https://doi.org/10.35576/2070-7940-2020-2-36-40

 

Organization of control purchases of medical devices

Keywords: control purchase, remote test purchase, medical devices, state control over the circulation of medical devices, The code of the Russian Federation on Administrative Offenses, the Criminal code of the Russian Federation

Introduction

This article discusses the main aspects of the organization and conduct of the control purchase of medical devices. A control purchase is organized and carried out in order to verify whether a legal entity or an individual entrepreneur complies with the mandatory requirements in the field of circulation of medical devices.

Control purchase is an inspection during which actions are taken to create situations for transaction (implementation of medical devices) in order to check whether a legal entity (LE), an individual entrepreneur (IE) comply with the mandatory requirements for the sale of goods, performance of work, provision of services to consumers [1, 2].

In accordance with the current legislation of the Russian Federation previously, only tax and law enforcement agencies were empowered to conduct control purchases. By the Decree of the Government of the Russian Federation from 21.11.2018 № 1398 are approved the Rules of organization and conduct of control purchase in the implementation of certain types of state control (inspection)1.

Thus, starting from January 7, 2019, the Federal Service for Surveillance in Healthcare in accordance with Federal law from 27.12.2018 № 511-FL «On Amendments to certain legislative acts of the Russian

Federation» is entitled to conduct rest purchase, incl. when conducting state control over the circulation of medical devices in terms of prohibition on the implementation of falsified, substandard, counterfeit medical devices.

The purpose of this work is to familiarize the subjects of the circulation of medical devices and medical community with important aspects of control purchase as a new type of state control that will allow to promptly identify circulating substandard, unregistered and falsified medical devices.

The procedure of control purchase conduct is described in the Administrative Order of the Federal Service for Surveillance in Healthcare in the implementation of state control over the circulation of medical devices approved by the order of Roszdravnadzor from 09.12.2019 № 92602.

Control purchase is conducted on grounds provided for unscheduled inspection.

The decision to conduct a control purchase is made in case an assessment of compliance with the requirements established by federal laws and other regulatory legal acts of the Russian Federation in accordance with them when implementing medical devices can be conducted only within framework of control purchase.

In other cases, according to the procedure established by Federal law from 26.12.2008 № 294-FL «On the protection of the rights of legal entities and individual entrepreneurs when implementing state control (inspection) and municipal control», a decision to conduct the unscheduled inspection is made.

To conduct a control purchase Roszdravnadzor employees they submit

 

to the head (his deputy) a motivated submission to conduct a control purchase with justification of its conduct, as well as the possibility of the assessment the requirements compliance only within the framework of a control purchase.

Upon agreement with a reasoned submission the head (his deputy) decides to conduct a control purchase and a corresponding order is prepared for its conduct.

A control purchase order includes the following information:

• the name of the supervisory authority, as well as the type (types) of state control (inspection) within the framework of which a control purchase is conducted;
• full name and the positions of the officials authorized to conduct a control purchase;
• information on the person being checked (the name of the LE (full name, IE), location of LE (place of IE activity) and (or) place of their actual activity, where a control purchase was directly conducted);
• state registration number of a LE creation record, number of a record of accreditation in the state register of accredited branches, representative offices of foreign LE, state register number of a record of a state registration of individual as IE and tax identification number (if the state control body (inspection) has the specified information);
• mandatory requirements with which the assessment of compliance is carried out during a control purchase;
• the basis of a control purchase;
• information on pharmaceuticals and medical devices to be
• purchased during a control purchase, purchase and payment methods;
• date of a control purchase conduct;
• information on the use of photo and filming, and video recording during a control purchase;
• information on coordination of a control purchase conduct with the procuracy authorities or notification of its conduct (indicating the date and number of a letter of coordination or notification);
• other information, if it is prescribed by the standard order form to conduct a control purchase.

When conducting a control purchase Roszdravnadzor employees can select medical devices on their own or with involvement of an employee (representative) of a legal entity or individual entrepreneur.

A control purchase is conducted by methods applied by customers when purchasing items (works, services) and making related transactions with legal entities and individual entrepreneurs, i.e., directly upon the actual purchase of a medical device.

Moreover, a control purchase can be conducted in a way that excluded direct contact of Roszdravnadzor employees with the workers (representatives) of a legal entity or an individual entrepreneur, in particular through the so-called remote test purchase.

 

Remote methods include:

1)         The use of postal networks;

2)         The use of electrocommunication, the Internet;

3)         The use of communication networks for broadcasting TV and (or) radio channels.

After the purchase of a medical device a control purchase is considered completed (except for the remote test purchase).

Please that the completed control purchase is not a completed activity. In this case, the word “completed” means that a transaction (acquisition) has occurred.

Further, the employees of Roszdravnadzor:

1)         announce to the representative of a legal entity or an individual entrepreneur about a control purchase;

2)         present service certificates and a copy of the order for its conduct;

3)         transfer to the representative of a legal entity or an individual entrepreneur a copy of the order to conduct a control purchase.

It should be noted that the direct familiarization of the representative of a legal entity or an individual entrepreneur with the order to conduct a control purchase occurs after purchasing a medical device. In this case the fact of familiarization of the inspected person with the order (receipt of a copy of the order by him) or the refusal from familiarization (receipt) a conduct of a control purchase must be stated in the act. In the context of remote test purchase an announcement of its conduct is realized by sending to a legal entity or an individual entrepreneur a copy of the order and an exemplar of the act of a control purchase conduct not later than the next day after the day of a control purchase conduct.

In case of a refusal from familiarization with the order and a receipt of the order copy, corresponding information is inserted to the act of a control purchase conduct.

A control purchase (except for control purchase conducted remotely using information and communication technologies) must be conducted in the presence of two witnesses or using a videorecording. If necessary, when a control purchase is conducted, photography and filming, videorecording and other established methods of fixation can be used.

It should be noted that Roszdravnadzor employees can use for the above-mentioned purposes the equipment included in the List of special technical facilities designated for law enforcement intelligence operations (approved by Decision of the Government of the Russian Federation from 01.07.1996 № 770).

The act of a control purchase conduct must be composed no later than 3 hours after the completion of a control purchase. In case a remote test purchase – no later than the next working day after its conduct.

The act of a control purchase is signed by an executive who conducted a control purchase and the witnesses (in case of their presence), and is also submitted for signature of the representative of a legal entity or an individual entrepreneur (except for remote test purchase).

The act of a control purchase is accompanied by documents confirming the fact of medical devices purchase, including sales checks and equivalent registrable forms.

If a legal entity or an individual entrepreneur refuse to sign the act of a control purchase, information about the refusal to sign is inserted to the act of a control purchase. A copy of the act is handed over immediately after its composition.

Claims on the content of the act (if any) can be reflected by the representative of inspected individual directly in the act or in the appendix to it. The regulatory documents do not contain any prohibition of indication objections in the act of a purchase.

When conducting a control purchase the official can purchase items (works, services) by cash or non-cash payment. After the announcement of a control purchase (incl. remote test purchase) money must be returned by:

1)         immediate return of cash to the official who conducted a control purchase;

2)         immediate ensuring and taking necessary actions to return the money transferred by non-cash payments to the account from which the payment of items (works, services) was made during a control purchase. The exception when it is not necessary to return the funds is cases:

1)         a purchase of goods for the purpose of their subsequent research or trials (the results of research or trials of goods are sent to the inspected person no later than the next working day after their registration);

2)         lost as a result of a control purchase of purchased goods (in particular, food products) of consumer properties;

3)         expenses incurred by a legal entity or an individual entrepreneur in connection with the work performance or the provision of services within the framework of a control purchase.

Medical devices purchased during a control purchase (except for the above cases) are returned to a legal entity or an individual entrepreneur. Medical devices are not returned in case of their withdrawal or arrest as a part of the application of measures to ensure the proceedings in a case of an administrative violation or a withdrawal of goods in other cases stipulated by the legislation of the Russian Federation.

In case of a remote test purchase the return of medical devices is conducted in a manner similar to the one that is applied by legal entities and individual entrepreneurs when making transactions with customers.

In case of sending of medical devices purchased during a control purchase to conduct research (trials) a corresponding note is made in the act with a list of these tools and devices. Transportation and storage of purchased medical devices are carried out in accordance with the information indicated on the labeling of medical devices and also in accordance with the rules established by technical regulations of EEAU or in case of their absence by regulatory acts of the Russian Federation.

The results of studies (trials) purchased during medical devices purchase are subject to be sent to a legal entity or an individual entrepreneur no later than the next day after its registration.

It should be noted that if during a control purchase the violations of the mandatory requirements are not revealed, the act of its conduct is composed in only one copy. The representative of a legal entity or an individual entrepreneur may not sign this act, while the refusal to sign is not marked.

The information about a control purchase and the results of its conduct is inserted to the unified register of inspections organized in order approved by the Decree of the Government of the Russian Federation from 28.04.2015 № 4153.

If violations of mandatory requirements are revealed during a control purchase by a legal entity or an individual entrepreneur the Roszdravnadzor employees:

1)         organize the conduct of unscheduled inspection on grounds stated in the article 10 of the Federal law from 26.12.2008 № 294-ФЗ «On protection of rights of legal entities and individual entrepreneur in the implementation of state control (inspection) and municipal control»;

2)         take measures to bring administrative responsibility in case of revealing sufficient data indicating a reason for initiating a case of an administrative violation.

In conclusion, it should be noted that in connection with the approval of the Rules of organization and a control purchase conduct in the implementation of certain types of state control (inspection) it becomes possible to actually conduct a control purchase in relation to subjects of the circulation of medical devices, carrying out their entrepreneurial activities in the field of circulation of medical devices.

Roszdravnadzor also recommends to legal entities and individual entrepreneurs, in respect of which a control purchase can be conducted to carefully familiarize with the current legislation of the Russian Federation regularizing the field of the circulation of medical devices.

It should be remembered that the subjects of the circulation of medical devices are brought to administrative responsibility by Roszdravnadzor and its territorial bodies for violations in the fields of circulation of medical devices in accordance with the art. 6.28 and 6.33 of the Code of the Russian Federation on administrative violations if these actions do not contain signs of a criminal offense, and for the circulation of falsified, substandard and unregistered medical devices are subject to criminal prosecution by law enforcement agencies in accordance with art. 238.1 of the Criminal code of the Russian Federation.

 

REFERENCES    

1. Novikova S.G. On control purchases conducted by Roszdravnadzor. –Pharmacy: accounting and taxation. – 2019. № 1. – Р. 67–75.
2. Aleksandrova N.V. Conducting control procurement in a pharmacy. – Pharmacy: accounting and taxation. – 2017. № 8. – Р. 53–58.

3 The Decree of the Government of the RF from 28.04.2015 № 415 (edit. from 31.10.2019) «On the Rules of formation and maintaining a unified register of inspections».