Medical Devices UKRAINE Magisters CONTACT INFORMATION Oleg Boichuk, Senior Associate Oleksandr Liulkov, Associate Magisters 38 Volodymyrska St., Kyiv, Ukraine +38044 492 82 82 www.magisters.com 1. Definition of medical devices What is the definition of a medical device in your jurisdiction? Medical devices means any instruments, appliances, devices, equipment, implants, materials, including invasive medical devices; medical devices for in vitro diagnostics; medical devices not achieving the main designated objective in the human's body or on it with the help of pharmacological, immunobiological or metabolic devices, but which may facilitate their functions; medical devices which may be used separately and in combination with each others, including software, required for their proper usage, with the purpose of assurance of: - prevention, diagnosis, treatment, observation (surveillance) or patient condition relief in case of disease, injury, mutilation or their compensation; - analysis, replacement or modification of the structure (anatomy) of the bodies, tissues or physiological processes; - fertilization process control. This definition is provided in accordance with Clause 2 of the Procedure of State Registration of the Medical Technique and Medical Devices approved by the Resolution of the Cabinet of Ministers of Ukraine No. 1497 of November 9, 2004.
2. Combination products i. Which legal regime (on medicinal product or on medical devices) applies to combination products incorporating both medicinal products (drugs/biologics) and medical devices? If a medical device incorporated into combination product cannot be repetitively used, such medical device falls within legal regime of medical products. Nevertheless, safety and efficiency requirements established for medical devices must apply to such medical device. If a combination product incorporating medicinal product as and integral part and causing auxiliary effect to human organism, such combination product falls within legal regime of medical devices. ii. Are combination products (combining drugs and medical devices) subject to separate regulation in your jurisdiction? No, combination products (combining drugs and medical devices) are not subject to separate regulation in Ukraine. iii. If the answer to (i) is negative, what is the scope of application of the legal regimes: evaluating both the drug and device components of the combination product? Please refer to answer to question 2 (ii). iv. What are the general conditions for review, approval and marketing the combination product? The following general conditions apply to the combination product which is subject to legal regime of the medicinal product: preclinical trials; clinical trials; state registration of the medical product. The following general conditions apply to the combination product which is subject to legal regime of the medical devices: completion of the conformance compliance procedure; and completion of the state metrological expertise (for measuring devices). 3. Borderline products Are there any official and binding criteria for determination whether the product is a medicinal product or medical device, or whether a product is a device requiring pre-review or a non-medical device? i. Are there any legal and binding criteria for determination whether the product is a medical device or medicinal product? Determination whether the product is a medical device or medicinal product is based on the statutory definitions of the medical device and the medicinal product. Definition of the medical device is provided in answer to question 1 above. Medicinal product is
defined as "substances or their mixture of natural, synthetical or biotechnological origination, which are applied for prevention of pregnancy, preventive treatment, diagnostics and treatment of deceases of people or change of conditions and functions of body" (Article 2 of the Law of Ukraine "On Medicinal Product" No. 123/96-ВР of April 4, 1996). Other than that there are no official and binding criteria for determination whether the product is a medicinal product or medical device. ii. If the answer to (i) is positive, what are the main principles for differentiation? iii. Are there any significant court or administrative judgments demonstrating the rules of product differentiation? iv. How is software that may have some related-medical applications regulated in your jurisdiction? Software that may have some related-medical applications is treated as a medical device and is regulated respectively. 4. Cellular or tissue based products Are there any official or binding criteria for determination whether a product is a animal or human based tissue or a medical device? i. How are products composed of cells or animal/human tissue regulated in your jurisdiction? The products composed of cells or animal/human tissue are generally subject to the same procedures as medical devices, although specific regulation of this matter is underdeveloped. ii. Are there any legal and binding criteria for determination whether the product is a medical device or cellular/tissue based product? These items are differentiated only by their definitions, which are quite broad. iii. If the answer to (ii) is positive, what are the main principles for differentiation? iv. Are there any significant court or administrative judgments demonstrating the rules of product differentiation?
5. Admission to trade of medical devices What are the requirements for admission (import) of medical devices into trade? i. Is clinical assessment required for admitting (importing) medical devices into trade? Yes, clinical assessment of medical devices is required for their admission (import) into trade. ii. If the answer to (i) is positive, are clinical trials required or is there an alternative basis for clinical assessment? Assessment of medical device implies completion of the clinical trials, except for certain types of ophthalmological products. Additionally no clinical assessment is required in such exceptional cases as, for instance, natural disasters, epidemics, etc. iii. Is certification by an external certifying body required for compliance assessment of medical devices, or is a manufacturer s declaration of conformity sufficient? Subject to type of medical device certification by an external certifying body or a manufacturer s declaration of conformity may be required. iv. Is administrative pre-clearance or pre-approval of medical devices required for admission of medical devices into trade, or is post-launch notification sufficient? Admission of medical device into trade is subject to state registration of medical device, which includes inter alia successful completion of clinical assessment. 6. Processing of personal data (privacy) What are the rules of processing of personal data in a number of activities performed by manufacturer/s distributors/ healthcare units with the use of medical devices. i. Are there any specific rules protecting the privacy of personal data of consumers purchasing medical devices, by manufacturer/distributors? No special rules in this regard are established by Ukrainian law. Therefore, general rules on protecting of personal's privacy shall apply. The only peculiarity is that rules protecting patient's privacy (i.e. secrecy of health condition, diagnosis etc) shall also apply. ii. Are there any specific rules of processing of personal data sourced by means of medical devices containing software, by healthcare units? No special rules in this regard are established by Ukrainian law. iii. Are there any specific rules of processing of personal data by manufacturers/distributors in case of collecting reports on medical incidents from customers? No special rules in this regard are established by Ukrainian law.
iv. What is the standard for reporting adverse events, and is reporting of events in foreign countries required, and using what standards? There is no standard for reporting adverse events, including reporting of events in foreign countries. Therefore, in case of any adverse events injured person may follow the general procedure of administrative complaints or litigation procedure. 7. Reimbursement What is the optimal model of reimbursement of medical devices? i. What are the rules of granting reimbursement of medical devices in your jurisdiction? Currently there is no established system of reimbursement of medical devices in Ukraine. 8. Distribution Is distribution and promotion of medical devices subject to legal regulation? i. Are there any specific regulations determining mode of business activity of medical devices distributors? There are no specific regulations determining mode of business activity of medical devices distributors. ii. Is administrative permit for medical devices distribution required? No specific administrative permit is required for distribution of medical devices. iii. Are there any specific limitations in distributing medical devices in your jurisdiction? Distribution of medical devices in Ukraine is allowed only upon state registration of the medical devices. iv. Are obligations of distributors of medical devices specifically legally regulated? No, obligations of distributors of medical devices are not specifically regulated. v. What specific rules exist for advertising and promoting medical devices? Ukrainian law sets forth the following specific rules as per advertising and promoting medical devices: the advertised medical devices must be duly registered; the advertised medical devices can be used without special knowledge and training; advertising may not contain inter alia: information, which can give rise to an impression, that in case of the use of the medical device, the specialist advice is not required; references to the medical device stating that it is the most efficient,
safest and exceptional without any side effects; comparisons to other medical device, made to strengthen the advertising effect, etc. the participation of doctors and other medical professionals, as well as individuals, whose appearance imitates that of medical doctors, in the advertising for medical devices is prohibited. 9. Manufacturing How are manufacturing practices regulated? i. Are there any specific standards or regulations determining the quality of manufacturing practices? Yes, Ukrainian law establishes specific standards or regulations determining the quality of manufacturing practices. The main regulations are as follows: (1) Resolution of the Cabinet of Ministers of Ukraine "On approval of Technical regulation concerning medical devices" No. 536 of June 11, 2008; (2) Resolution of the Cabinet of Ministers of Ukraine "On approval of Technical regulation concerning implantable medical devices" No. 621 of July 9, 2008; (3) Resolution of the Cabinet of Ministers of Ukraine "On approval of Technical regulation concerning medical devices for laboratory diagnostics in vitro" No. 641 of July 16, 2008. ii. If the answer to (i) is positive, how are these good manufacturing practices or quality system regulations reviewed and enforced? The mentioned enactments are reviewed and enforced by means of adoption of the relevant amendments to these enactments by the authority which initially issued the mentioned acts. Enforcement of these acts falls within the competence of, inter alia, the Ministry of Healthcare of Ukraine, State Inspection on Control of Quality of Medicinal Products. iii. Are establishments manufacturing medical devices, or components of medical devices, required to be registered with a government regulator? The establishments manufacturing medical devices or components of medical devices are not required to be specially registered with a government regulator. iv. Are these establishments inspected regularly by government regulators or authorized bodies, and what is the mode of such inspections? These establishments are subject to different types of inspections. In particular, (a) based on periodicity of the inspections, the later may be (i) schedule, or (ii) off-schedule; (b) based on place of holding (i) visiting; or (ii) documental. 10. Regulatory Guidance How are the requirements communicated to medical device manufacturers?
i. In what form do the laws and regulations appear that are applicable to medical device manufacturers? The laws and regulations applicable to medical device manufacturers appear in the following forms: laws of Ukraine, adopted by Ukrainian Parliament; resolutions, adopted by the Cabinet of Ministers of Ukraine; and orders and regulations, adopted by the Ministry of Healthcare of Ukraine, State Inspection on Control of Quality of Medicinal Products. ii. Are informal guidance or the opinions of regulators available to device makers, and in what form? Generally, the regulators may express their guidance or the opinions in the form of the letters or clarifications. Such guidance is not binding but is generally respected in practice.