Services

Company "Сratia Medtekhnika" LLC provides the following services:

  • Performance of the functions of the Authorised representative of manufacturer of medical devices, if manufacturer is not a resident of Ukraine;
  • Procedure of conformity assessment of medical devices, medical devices for in-vitro diagnostic and active implantable medical devices to the requirements of Technical Regulations №753, №754, №755;
  • Legal support, protection from "gray" imports and interaction with market surveillance authorities;
  • Development of labeling of medical devices in accordance with the requirements of the current legislation;
  • Development of instruction for use of medical devices in Ukrainian language;  
  • Independent examination of medical devices in accredited laboratories;
  • Postmarketing surveillance;
  • Investigation of probable incidents;
  • Support in the issues of the utilization of medical devices;  
  • Support in the issues of the tender operations (in accordance with the authority of the Authorised representative of manufacturer);
  • Support in the issues of the customs clearance of medical devices (in accordance with the authority of the Authorised representative of manufacturer).

 

Since July 01, 2017, the import and putting into service of medical devices on the territory of Ukraine requires confirmation of compliance with the requirements of the Technical Regulations. Despite the fact that the Technical Regulations are based on the EU Directives, there are many national differences:

  • CE mark, affixed on the medical devices does not give the right of their importation and putting into service on the territory of Ukraine; to put medical devices into service on the territory of Ukraine, such devices have to be marked by national mark of conformity to the Technical Regulations; 
  • In accordance with the requirements of the Technical Regulations, if manufacturer is not a resident of Ukraine, an Authorised representative on the territory of Ukraine must be appointed;
  • European Notified bodies do not have an appointment in Ukraine, hereby the conformity assessment procedure must be carried out by the national conformity assessment bodies;
  • The labeling of medical devices must be provided in Ukrainian language; the mandatory information on the label of medical devices should be specified in accordance with the requirements of Technical Regulations; the symbols on the labeling are applied according to DSTU EN 980:2007 (standard EN ISO 15223-1: 2012, which operates in the EU, does not change the characters of DSTU EN 980: 2007, but introduces some new symbols, which are not required for our region). You can find detailed information on labeling of medical devices at the following link: http://cratia.ua/labeling_requirements_en;
  • The instructions for use of medical devices, intended for the Ukrainian market, must be set out in Ukrainian language, contain a mark of conformity assessment to the Technical Regulations and explanation of the symbols indicated on the labeling;

Performance of the responsibilities of the Authorised representative of the manufacturer, if the last one is not a resident of Ukraine:

The Authorised representative of the manufacturer is a connecting link between the manufacturer  and Ukraine (conformity assessment bodies, market surveillance authorities, revenue and fees authorities, consumers, etc.), performing a number of special functions assigned to it by the requirements of the national legislation in the field of Technical regulation.

The relations between the manufacturer and the Authorised representative of manufacturer on the territory of Ukraine is established by the Agreement and/or Power of Attorney. The agreement is more appropriate for the settlement of rights and obligations of both parties, coverage of liability issues of the Authorised representative and the manufacturer regarding quality and safety, the terms and order of mutual communications, the procedure for dealing with complaints and alerts, and many other aspects such as the implementation of postmarket surveillance and proper storage and provision of relevant documentation upon request.

The Authorised representative is required to keep the documents for at least 5 years (for implantable medical devices - not less than 15 years) to provide on request of state authorities and/or conformity assessment body.

Information containing the name and address of the Authorised representative must be specified on the packaging of each medical device and/or the instruction for use.

In this case, each medical device (type/model) must be associated with only one Authorised representative. At the discretion of the manufacturer, a distributor, and a representation, or a third party can act as an Authorised representative. It should be noted that the appointment of the Representative Office of the manufacturer in Ukraine as an Authorised representative entails serious risks of violating the requirements of the current legislation on the prohibition on conducting business activities: the regulatory actions for products manufactured at other plants of the holding or at contract plants may be regarded as the provision of services by third parties that are commercial activities.

By concluding an agreement on the appointment of the Authorised representative, the important point is not only compliance with all essential conditions of the national legislation on such agreements, but also the correct interpretation of the provisions on the rights and obligations of the parties in order to prevent conflicts, controversial issues of legitimacy and legality of certain actions of the parties in the future.

An example is the norm on the responsibilities of the Authorised representative, at the request of the competent authorities, to immediately remove the devices, which do not meet the requirements for its introduction, has caused or may cause harm to the consumer and/or his life and health, from circulation.In this case, the terms of the agreement on the approval or agreement of such actions with the Manufacturer shall not be taken into consideration by representatives of market surveillance authorities.

Most often, manufacturers share the resncibilities of the authorised persons on a certain territory on commercial (financially representative) partners and those responsible for regulatory issues (Authorised representative), trying to accurately and precisely identify, outline, and limit their possible actions. Before concluding the agreement, we recommend to take into account all peculiarities of the Authorised representative's activities and possible "pitfalls" in order to minimize liability in the future.As a rule, even the definition of all direct responsibilities (rights) of the Authorised representative in the Agreement is not enough to provide a complete guarantee of the commercial security of such activities.

Since the market surveillance authorities consider the Authorised representative on the territory of Ukraine as the Manufacturer, in the unfavorable situation, the Authorised representative takes on "the first wave of compensatory character", which must be "withstanded" until the transfer of responsibility of the Manufacturer and further compensation of the incurred costs.To do this, we strongly recommend to carries out professional liability insurance, when signing the agreement on Authorised representative appointment. Such insurance can cover expenses caused by unforeseen circumstances in the future, related not only to the quality of products but also to the lack of professionalism of direct employees acting on behalf of the Authorised representative.Such insurance, together with a properly concluded agreement, is part of a regression mechanism, which means the inverse right to claim the reimbursement of the amount paid, brought by one legal entity to another obligated person.

From personal practice, the company "Сratia Medtechnika" has professional liability insurance amounting to 1 million UAH.

It is also not appropriate to postpone the resolution of disputes over the activities of the Authorised representative in Ukraine to another jurisdiction, since its actions are directly regulated by national legislation in the field of technical regulation and market surveillance. An exception may be commercial issues, the issue of compensation, business integrity and ethics of the relationship between the parties.

If, for any reason, the manufacturer does not have a partner in Ukraine for the appointment of an Authorised representative, we are ready to ensure that this complex of works and commitments are implemented.We are not involved in commercial issues of activity or  turnover processes, which guarantees competent, professional and non-engagement of fulfilled commitments.

To do this:

  • we sign the Agreement on the appointment of the Authorised representative on the territory of Ukraine;
  • we assign a telephone number and a responsible employee;
  • we get SOP (if any) from the manufacturer and strictly follow their terms;
  • the name, address and contact number of our company will be placed on the packaging of medical products;
  • we perform the responsibilities and functions of the Authorised representative on the territory of Ukraine;
  • our liability to third parties is insured in accordance with the Agreement on voluntary professional liability insurance.

 

Conformity assessment of medical devices, medical devices for in vitro diagnostic, active implantable medical devices to requirements of Technical Regulations №753, №754, №755

Conformity assessment is any activity aimed at determining whether the process, product or service meets the requirements of the relevant technical standards and/or fulfills of the relevant requirements.

It is worth to pay attention to the fact that the affixing of the CE mark on the label of the medical device, as well as the availability of documentation confirming compliance with the European Directives on medical devices and the right to place the product on the EU market, does not give the rights to place such products on the Ukrainian market without the conducting of national conformity assessment procedure. Also, the availability of previous registration of devices in Ukraine practically does not facilitate the issue of conducting the conformity assessment procedure, and the results of technical, pre-clinical and clinical examinations cannot be counted as a confirmation of compliance with the Technical Regulations. 

For all medical devices that are being put into service since July 1, 2015, it is necessary to pass an assessment of compliance with the Technical Regulations (Resolution of the Cabinet of Ministers of Ukraine №753 dated October 2, 2013, Resolution of the Cabinet of Ministers of Ukraine №754 dated October 2, 2013 and Resolution of the Cabinet of Ministers of Ukraine №755 dated October 2, 2013).

The procedure of conformity assessment to the Technical Regulations is carried out in different ways, depending on the class of the medical device and allows to choose the scope of expertise.In particular, it is worth to specify the procedures of inspection of production or the conformity assessment procedure of a batch of devices.

A class of medical device determines the need of involving  of a conformity assessment body: for the safest devices, it is enough to conduct a self-declaration procedure. For other medical devices, it is required to undergo the examination of documentation and inspection of production, having received a certificate of conformity for 5 years, or undergo the conformity assessment procedure on a batch, having received a certificate once for a specific batch of devices.

Self-declaration:

  • Medical devices of class I (non-sterile, without measuring functions) in accordance with Technical regulation on medical devices (Resolution of the Cabinet of Ministers of Ukraine №753 dated October 2, 2013); 
  • Analyzers, reagents, calibrators and controls, which are not included in the List A and List B of the Technical Regulations on medical devices for in vitro diagnostics (Resolution of the Cabinet of Ministers of Ukraine №754 dated October 2, 2013), not intended for self-control.

Conformity assessment procedure with the involvement of the conformity assessment body: 

  • Medical devices of classes Is (sterile), I with measuring functions, IIa, IIb, III in accordance with Technical regulation on medical devices (Resolution of the Cabinet of Ministers of Ukraine №753 dated October 2, 2013); 
  • Reagents, calibrators and controls included in the List A and List B of the Technical Regulations on medical devices for in vitro diagnostics (Resolution of the Cabinet of Ministers of Ukraine №754 dated October 2, 2013), devices for self-control;
  • All medical devices, which are the subject to action of Technical regulation on active implantable medical devices (Resolution of the Cabinet of Ministers of Ukraine №755 dated October 2, 2013);

To carry out an assessment of compliance with the Technical Regulations, "conformity assessment bodies" (analogous to "notified bodies" in the EU) are involved. Conformity assessment bodies conduct examination of documentation, inspection of production and product testing. To date, 12 bodies of state and private ownership have been appointed, the list of which is available on the website of the State Service, the National Accreditation Agency of Ukraine and the Ministry of Economic Development and Trade of Ukraine.

The application for conformity assessment procedure and related documents shall be submitted to one of the conformity assessment bodies, as well as the letter of guarantee that the same Application has not been submitted to another conformity assessment body.The conformity assessment bodies may differ in the type of products for which they received the appointment, the group of experts and inspectors, which may have a significant impact on the requirements for translation, terms, and other features of the procedure.The choosing of the conformity assessment body is an important and responsible decision that can have a significant impact on both the initial procedure and the subsequent commitment. It is extremely not recommended to change the chosen conformity assessment body, otherwise it will cause to pass the part of the procedure again, as well as to make a payment again. Beginning of the form The end of the form

The mandatory requirement of the Technical Regulations on medical devices of all classes and all types of conformity assessment procedures is the appointment of an Authorised representative of the manufacturer in Ukraine in the event that the manufacturer himself is not a resident of Ukraine.The name and address of the Authorised representative of manufacturer in Ukraine must be placed on the packaging of each medicinal device and/or in the instructions for use.The Authorised representative in Ukraine is a link between Ukraine (conformity assessment bodies, market surveillance authorities, revenue and fees authorities, consumers, etc.) and the manufacturer, performing post-market monitoring.The Authorised representative in Ukraine acts on the basis of the Power of Attorney and the agreement with the manufacturer.

Requirements regarding the labeling and instructions for use:

The affixing of the National mark of conformity, the indication of the name and the address of the Authorised representative of the manufacturer in Ukraine are important innovations regarding the labeling of medical devices that have passed the conformity assessment procedure.The description of the conformity mark was approved by the Resolution of Cabinet of Ministers of Ukraine №11884 dated December 30, 2015, however, the Technical Regulations specify the requirements for the size of the mark.If the conformity assessment procedure was carried out with the involvement of the conformity assessment body, its number should be indicated next to the National mark of conformity.

A number of innovations, listed in the Technical Regulations, which should be taken into account when preparing the product before being put into service, also apply on the Instructions for use. The information in the instructions for use and labeling of the medical devices must be submitted in Ukrainian in accordance with the Law of Ukraine "On the Principles of the State Language Policy", and may include other languages.

Market surveillance.

Technical regulations on medical devices are the part of a national system of technical regulation of products, which includes monitoring of the implementation and compliance with safety requirements when putting products into service in the Ukrainian market. State Service on Medicines and Drugs Control (SMDC)is the body of market surveillance of medical devices that have passed the conformity assessment procedure.According to Art. 15 of the Law "On State Market Surveillance and Control of Non-Food Products", officials of the market surveillance body have the right to conduct documentary inspections and examination of samples of products, sampling and testing and to visit freely:

  • commercial premises and warehouses;
  • places of use of products during its installation and/or putting into operation;
  • location of exhibitions or product demonstrations;
  • places of storage of products whose registration has been terminated as a result of control.

LLC ‘Сratia Medtechnika’ provides services and performs works on the conformity assessment of medical devices to the requirements of the Technical regulations on a ‘turnkey basis’. We possess the necessary knowledge, experience and practice of carrying out all necessary work. We will take over the management and organization of the process, help form a package of documentation and conduct the procedure in a short time.

We provide:

  • all necessary consultations regarding the requirements of the Technical Regulations, the list of necessary documents and their legalization, selection of procedures, etc.;
  • professional examination of documentation until it is submitted to the designated body;
  • individually developed bilingual (Ukrainian-English) Agreement on the appointment of the Authorised representative of the manufacturer in Ukraine;
  • objective and professional advice on the choice of the conformity assessment body, taking into account the composition of the experts, the political and economic situation, prospects of development, etc.;
  • translation of necessary documents, including notarial certification of necessary documents; we carry out translations on our own, which ensures their high medical level;
  • on the basis of the Power of Attorney we represent interests of our partners in the designated authorities: we conduct negotiations, submit a package of documents, receive comments, agree on the procedure of inspection, select samples, make payment and so on;
  • answers to expert questions; control compliance with all terms and conditions;
  • development of draft of labeling and instructions (user manual);
  • development of the Declaration of Conformity to the requirements of the Technical Regulations.

Legal support, protection from "gray" imports and interaction with market surveillance authorities.

Monitoring: checking of the wholesale and retail trade network, pharmacies, clinics, the Internet for the presence of goods of illegal "gray" imports

Our specialists provide the following services:

  • monitoring of markets for the sale of goods for health;
  • tracking the facts of the implementation of the "gray" import of such goods;
  • initiation of the introduction into Unified Register of Pre-Trial Investigations* of the revealed facts of illegal use of intellectual property rights, counterfeiting of such goods, etc.;
  • practical assistance to the business entity when entering information about the objects of intellectual property into the customs register;
  • monitoring of pricing policies for similar products;
  • cooperation with pharmacists and distributors to prevent the sale of "gray imports" products.

 

Preparation of claims, procedural support in cases of "gray import"

Our lawyers provide the following services:

  • legal analysis of the controversial situation and provision of conclusions on possible ways to protect the rights and legitimate interests of the Client;
  • collection, analysis of evidence and definition of the tactics of doing business in this category in court;
  • study of court practice in disputes arising from such legal relations;
  • preparation and submission of lawsuits and other procedural documents in cases on the facts of the implementation of "gray import" to court;
  • familiarization with the materials of the cases of this category in court, as well as oral and written counseling of the client on the progress of further actions on the results of their familiarization;
  • consulting on increasing or reducing the amount of the prayer for relief, refusal of a claim, conclusion of an amicable agreement in the course of judicial consideration of cases of this category;
  • representation of clients in the court of first instance, the appellate court and the Supreme Economic Court of Ukraine in cases of this category;
  • appeal of decisions, rulings, court decisions in cases of the aforementioned category in appeal and cassation procedures;
  • legal assistance in compensation of property and moral (non-property) damage (losses) incurred by the client by the products of "gray import";
  • restoration of missed procedural deadlines.

 

Preparation of appeals to market surveillance bodies, representation of client's interests in market surveillance authorities regarding "gray import"

We will prepare the requests in a qualitative and timely manner, carry out their legal analysis on compliance with the requirements of the current legislation. We will assist you in gathering of the necessary evidence to confirm the facts of the realization of "gray" medical devices, with your prior consent, we will apply to the relevant body of state market supervision, where we’ll carry out its further full legal support and monitoring up to the moment of direct consideration.

In addition, with the appropriate power of attorney, we will represent our clients in the above-mentioned market surveillance bodies on any issues independently, acting on the basis of mutually beneficial cooperation.

 

Development of labeling of medical devices in accordance with the requirements of the current legislation.

Requirements on the labeling of medical devices are contained in a number of Laws, Resolutions of Cabinet of Ministers of Ukraine and Standards:

  • Law of Ukraine "On Technical Regulations and Conformity Assessment";
  • Law of Ukraine "On Protection of Consumer Rights";
  • Law of Ukraine "On general safety of non-food products";
  • Law of Ukraine "On the Principles of State Language Policy";
  • Technical regulations on medical devices, medical devices for in vitro diagnostic and active implantable medical devices, approved by relevant resolutions of Cabinet of Ministers of Ukraine;
  • DSTU EN 980:2007 "Symbols for use in the labelling of medical devices";
  • DSTU 3798-98 (IEC 60601-1:1988) "Medical electrical equipment. Part 1. General requirements for safety" (for active devices) etc. 

Requirements on labeling, established by obligatory norms, are the subject of unconditional fulfillment. While voluntary standards contain recommendations of an advisory nature, which also become mandatory for specific products after the manufacturer has declared it to be complied with.

The company LLC "Сratia Medtechnika" can assist you in checking and developing of packaging labels of medical products and medical equipment, namely:

  • checking of existing packages on compliance with the requirements of the current legislation;
  • development of labels (stickers);
  • development (localization) of mockup of a package.

 

Development of instructions for use in Ukrainian language.

A number of innovations, listed in the Technical Regulations, which should be taken into account when preparing the product before being put into service, also apply on the Instructions for use. The information in the instructions for use of the medical devices must be submitted in Ukrainian in accordance with the Law of Ukraine "On the Principles of the State Language Policy", and may include other languages.