On signing an Agreement on Common Principles and Rules for the Circulation of Medical Devices (medical devices and Medical Equipment) within the framework of the Eurasian Economic Union
Decree of the President of the Republic of Kazakhstan dated December 19, 2014 No. 980
I DECREE:
1. To approve the attached draft Agreement on Common Principles and Rules for the Circulation of Medical Devices (medical Devices and Medical Equipment) within the framework of the Eurasian Economic Union.
2. Authorize the First Deputy Prime Minister of the Republic of Kazakhstan, Sagintayev Bakhytzhan Abdirovich, to sign on behalf of the Republic of Kazakhstan an Agreement on Common Principles and Rules for the Circulation of Medical Devices (medical devices and medical equipment) within the framework of the Eurasian Economic Union, authorizing amendments and additions that are not fundamental.
3. This Decree shall enter into force from the date of signing.
President of the Republic of Kazakhstan N.Nazarbayev
APPROVED
By Presidential Decree
Republic of Kazakhstan
Dated December 19, 2014 No. 980
Project
agreement
on common principles and rules for the circulation of medical products (medical devices and medical equipment) within the framework of the Eurasian Economic Union
The member States of the Eurasian Economic Union, hereinafter referred to as the member States, based on the Treaty on the Eurasian Economic Union of May 29, 2014, recognizing the expediency of conducting a coordinated policy in the field of circulation of medical devices (medical devices and medical equipment) (hereinafter - medical devices), taking into account mutual interest in ensuring guarantees of safety, quality and effectiveness of medical devices for human life and health, environmental protection, property of legal entities and individuals, prevention of actions misleading consumers (users) of medical devices, recognizing that medical devices belong to socially significant products, in order to form the common market of medical devices within the framework of the Eurasian Economic Union (hereinafter - The Union), striving to increase the competitiveness of medical devices manufactured within the Union, striving to eliminate restrictions in mutual trade, agreed on the following:
Article 1 Scope of the Agreement
1. This Agreement establishes common principles and rules for the circulation of medical devices within the Union in order to form a common market for medical devices. 2. This Agreement applies to legal relations related to the circulation of medical devices intended for circulation within the Union, as well as medical devices in circulation within the Union. 3. The regulation of the circulation of medical devices within the Union is carried out in accordance with the Treaty on the Eurasian Economic Union of May 29, 2014, this Agreement, other international treaties constituting the law of the Union, decisions of the Commission, as well as the legislation of the member States.
Article 2 Definitions
For the purposes of this Agreement, concepts are used that mean the following: "release into circulation of medical devices" - any paid or gratuitous transfer of medical devices that is carried out for the first time and makes them available for distribution and (or) use, with the exception of the transfer of medical devices for research (testing) for the purpose of their subsequent sale and use.; "medical products" - any instruments, apparatuses, devices, equipment, materials and other products that are used for medical purposes alone or in combination with each other, as well as with accessories necessary for the intended use of these products (including special software), are intended by the manufacturer for the prevention, diagnosis, treatment of diseases, medical rehabilitation and condition monitoring human body, conducting medical research, restoration, replacement, modification of the anatomical structure or physiological functions of the body, prevention or termination of pregnancy and the functional purpose of which is not realized by pharmacological, immunological, genetic or metabolic effects on the human body, however, it can be supported by medicines.; "circulation of medical devices" - design, development, creation of prototypes, conducting technical tests, research (tests) to assess the biological effect, clinical trials, safety, quality and effectiveness of medical devices, registration, production (manufacture), storage, transportation, sale, installation, commissioning, application (operation), maintenance, repair and disposal of medical devices.
Article 3The implementation of a coordinated policy in the field of medical device circulation
1. The Member States shall form a common market for medical devices within the Union in accordance with the principles specified in Article 31 of the Treaty on the Eurasian Economic Union of May 29, 2014. 2. The Member States shall pursue a coordinated policy in the field of medical device circulation by: a) taking measures necessary to harmonize the legislation of the Member States in the field of medical device circulation; b) establishing common requirements for the safety and effectiveness of medical devices within the Union.; c) establishing uniform rules for the circulation of medical devices in accordance with the recommendations of the International Forum of Medical Device Regulators (IMDRF); d) defining common approaches to creating a quality assurance system for medical devices; e) harmonizing the nomenclature of medical devices used in the Member States with the Global Nomenclature of Medical Devices (Global Medical Device Nomenclature); f) harmonization of the legislation of the Member States in the field of control (supervision) in the field of circulation of medical devices (medical devices and medical equipment). 3. For the purposes of implementing this Agreement, the Member State determines the state authority(s) authorized to carry out and (or) coordinate activities in the field of medical device circulation in the territory of the Member State (hereinafter referred to as the authorized body), and informs the other Member States and the Eurasian Economic Commission about it. (hereinafter referred to as the Commission). 4. The coordination of activities aimed at harmonizing the legislation of the Member States in the field of medical device circulation is carried out by the Commission. 5. The harmonization of the legislation of the Member States in the field of medical device circulation is carried out on the basis of international standards, taking into account the decisions of the Commission in the field of medical device circulation. 6. The authorized bodies cooperate in the field of medical device circulation, including through the organization and coordination of scientific research, scientific and practical conferences, seminars and other events. The authorized bodies carry out events on the exchange of experience and organization of joint training of specialists in the field of medical device handling. The authorized bodies or organizations of the Member States acting on their behalf shall conduct consultations with the participation of representatives of the Commission aimed at coordinating the positions of the Member States on the treatment of medical devices.
Article 4 Registration of medical devices
1. The provisions of this article shall apply to medical devices put into circulation within the Union from the date of entry into force of this Agreement. 2. Medical products put into circulation within the Union are subject to registration in accordance with the procedure established by the Commission. Registration of medical devices is carried out by authorized bodies. The examination of the safety, quality and effectiveness of medical devices for the purpose of their registration is carried out by an expert organization determined by the state body of the Member State in the field of healthcare, in accordance with the procedure approved by the Commission. 3. When registering, the same requirements are imposed on medical devices manufactured within the Union and imported into the customs territory of the Union from third countries. 4. In order to register medical devices, technical tests, studies (tests) are carried out to assess the biological effect, clinical trials, tests to approve the type of measuring instruments (for medical devices related to measuring instruments, the list of which is approved by the Commission) and an examination of the safety, quality and effectiveness of medical devices. Rules for classifying medical products depending on the potential risk of use, Rules for maintaining the nomenclature of medical products, general requirements for the safety and effectiveness of medical products, requirements for the operational documentation of medical products, Rules for conducting research (testing) of medical products, Rules for registration of medical products (including requirements for the registration dossier, registration application, grounds and the procedure for suspending or canceling the validity (cancellation) of a medical device registration certificate), The rules for the examination of the safety, quality and effectiveness of medical devices are approved by the Commission. 5. The authorized bodies determine the list of institutions, organizations and enterprises, including medical institutions and organizations authorized to conduct research (testing) of medical devices for the purpose of their registration (hereinafter referred to as authorized organizations). The requirements for authorized organizations and the procedure for assessing their compliance with these requirements are established by the Commission. 6. The document confirming the registration of a medical device is the registration certificate of a medical device operating within the Union. The form of the registration certificate and the rules for filling it out are established by the Commission. The registration certificate is permanent. 7. Member States shall create conditions for ensuring the conformity of research methods and conditions and the comparability of examination results through the application of common safety and efficacy requirements for medical devices and uniform requirements for authorized organizations. 8. The authorized bodies mutually recognize the results of research (tests) and examinations obtained during the registration procedures for medical devices, provided that they are carried out in accordance with the requirements and rules established by the Commission. 9. The settlement of disagreements arising between the authorized bodies during the registration of medical devices is carried out in accordance with the procedure established by the Commission. 10. The decision of the authorized body to refuse to issue a medical device registration certificate may be appealed by the manufacturer of the medical device or its authorized representative to the court of a Member State in accordance with the procedure provided for by the legislation of that Member State. 11. Within the Union, medical devices are not subject to registration: a) imported by individuals into the customs territory of the Union and intended for personal use; b) which are manufactured on the territory of a member state on individual orders from patients exclusively for personal use and which are subject to special requirements in accordance with the designation issued by a medical professional; c) imported on the customs territory of the Union for use by employees of the diplomatic corps; (d) Imported into the customs territory of the Union to provide medical assistance to passengers and crew members of vehicles, train crews and drivers of vehicles arriving in the territory of the Union; (e) imported into the customs territory of the Union to provide medical assistance to participants in international cultural, sporting events and participants in international expeditions, as well as for exhibitions; (f) imported into the customs territory of the Union for research (testing), including for scientific purposes; g) imported into the customs territory of the Union as humanitarian aid in cases determined by the legislation of the Member States.
Article 5The release of medical devices into circulation within the framework of the Union
1. The manufacturer or his authorized representative is responsible for the release of a medical product into circulation within the Union. 2. It is prohibited to issue a medical device into circulation within the Union if: a) there is an official notification from the authorized body, the manufacturer and (or) its authorized representative that the circulation of the medical device has been suspended, or it has been withdrawn from circulation, or it has been withdrawn by the manufacturer; b) the service life (expiration date) of the medical device has expired. products; c) a medical device is not registered in accordance with the established procedure (with the exception of medical devices that are not subject to registration in accordance with paragraph 11 of Article 4 of this Agreement).
Article 6 Manufacture of medical devices
1. The manufacturer of medical products intended for circulation within the Union ensures the implementation and maintenance of a quality management system for medical products. The requirements for the implementation, maintenance and evaluation of a quality management system for medical devices, depending on the potential risk of their use, are established by the Commission. 2. The manufacturer creates and maintains an up-to-date system for collecting and analyzing data on the use of medical devices, tracking and detecting side effects of medical devices during operation. The manufacturer sends reports to the authorized bodies based on the experience of clinical use of certain types of high-risk medical devices in accordance with the procedure established by the Commission. If medical devices are found to be inconsistent with the general safety and effectiveness requirements of medical devices or information is received about facts and circumstances that endanger human life or health, the authorized body shall notify the authorized bodies of other Member States within 5 days and take measures to prevent the circulation of such medical devices on the territory of its State. 3. In case of termination of production of a medical device, the manufacturer or his authorized representative must provide relevant information to the authorized body that issued the registration certificate of the medical device within 30 calendar days from the date of the decision to terminate production of the medical device.
Article 7 Labeling of medical devices
1. Medical products that have passed the procedures established within the Union for registration and confirmation of compliance with the general requirements for the safety and effectiveness of medical products, requirements for the implementation and maintenance of a quality management system for medical products, before being put into circulation within the Union, are subject to mandatory labeling with a special circulation mark for medical products on the Union market (hereinafter referred to as the special circulation mark). 2. The manufacturer or his authorized representative is responsible for unjustifiably labeling a medical device with a special treatment mark. 3. If the authorized body determines that the labeling of a medical device with a special treatment mark is being used unreasonably by a manufacturer or its authorized representative, it must inform the authorized bodies of other Member States and the Commission about this violation and take the necessary measures to remove such medical device from circulation in its territory and bring the perpetrator to justice.. 4. The requirements for labeling medical devices, the image of a special treatment mark and the Regulation on a special treatment mark are approved by the Commission. 5. Medical devices are not marked with a single product circulation mark on the Union market.
Article 8 Control over the circulation of medical devices and monitoring of safety, quality and effectiveness of medical devices
1. Control over the circulation of medical devices is carried out in relation to legal entities and individuals registered as individual entrepreneurs who carry out activities in the field of circulation of medical devices within the Union, in accordance with the procedure established by the legislation of the member States. 2. The rules for monitoring the safety, quality and effectiveness of medical devices are established by the Commission. 3. In case of detection of the fact of circulation of substandard, counterfeit or falsified medical devices within the Union that pose a danger to human life and (or) health, the authorized body, within 5 days after the establishment of such a fact, notifies the authorized bodies of other member States and sends the relevant information to the Commission, and also has the right To take measures, in accordance with the procedure established by the Commission, to suspend or ban the use of these medical devices and withdraw them from circulation. 4. When facts affecting the safety, quality and effectiveness of medical devices are identified, the authorized body informs the manufacturer of the medical device or its authorized representative about this and has the right to request additional information about the medical device from him. 5. The authorized body has the right to: conduct an additional examination of the safety, quality and effectiveness of a medical device, taking into account the identified negative consequences of its use in cases provided for by the legislation of the member state.; suspend the validity of the medical device registration certificate issued by him; cancel (cancel) the validity of the medical device registration certificate issued by him. The grounds and procedure for suspending or canceling the validity (cancellation) of a medical device registration certificate are determined by the Rules for Registration of Medical Devices approved by the Commission. The authorized body shall immediately inform the authorized bodies of other Member States, the manufacturer or his authorized representative and the Commission about the suspension or cancellation of the registration certificate of a medical device, as well as the notification of the need for additional examination of a medical device.
Article 9INFORMATION system in the field of medical device circulation
1. In order to ensure conditions for the circulation of safe, high-quality and effective medical products within the Union, the Commission forms and maintains an information system in the field of circulation of medical products (hereinafter referred to as the information system), which is part of the integrated information system of the Union and includes: a) a single register of medical products registered within the Union; b) a single register of authorized organizations; c) a unified information database for monitoring the safety, quality and effectiveness of medical devices. 2. The procedure for the formation and maintenance of the information system is established by the Commission. The authorized bodies submit to the Commission the necessary information for the formation of the information system. 3. The information included in the information system is publicly available and posted on the Commission's official website on the Internet.
Article 10 Confidentiality of information
1. The authorized bodies and the Commission shall take the necessary measures to protect confidential information received and transmitted by them under this Agreement, including personal data. 2. In order to transfer confidential information received by the authorized body and/or the Commission to third parties in accordance with this Agreement, the prior consent of the person who provided this information is required. 3. Information and information contained in the registration certificate of a medical device and the information system cannot be classified as confidential information.
Article 11The transition period
Documents confirming the fact of state registration of medical devices and issued by the authorized body prior to the entry into force of this Agreement are valid in the territory of the Member State until their expiration, but no later than December 31, 2021.
Article 12 Dispute resolution procedure
Disputes related to the interpretation and/or application of this Agreement are resolved in accordance with the procedure established by Article 112 of the Treaty on the Eurasian Economic Union of May 29, 2014.
Article 13The present Agreement and the law of the Union
This Agreement is an international agreement concluded within the framework of the Union and is included in the law of the Union.
Article 14 Amendment of the Agreement
By mutual agreement of the Member States, this Agreement may be amended, which are formalized in separate protocols, and are an integral part of this Agreement.
Article 15The entry into force of the Agreement
This Agreement will enter into force on January 1, 2016.
Committed in the city _____________ "___" ____________ 20__ year in one original copy in Russian. The original copy of this Agreement shall be kept at the Eurasian Economic Commission, which, as the depositary of this Agreement, will send each member State a certified copy thereof.
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