Medical devices and medicines in Ukraine
The manufacture, import, distribution, and sale of medical devices and medicinal products in Ukraine are subject to mandatory regulatory requirements.
Medical devices must undergo a conformity assessment procedure in accordance with the applicable Technical Regulations for medical devices, which establish safety, quality, and performance requirements. The applicable procedure depends on the type of device and its safety classification.
Medicinal products may be placed on the Ukrainian market only after state registration in accordance with the Law of Ukraine “On Medicinal Products”. State registration grants permission for the medical use and commercial circulation of medicines in Ukraine.
Certain limited categories of medicines may be imported without registration in exceptional cases defined by law. However, in general, both medical devices and medicines must complete the relevant regulatory procedures before being introduced into the Ukrainian market.
Registration of medical devices
Medical devices are regulated under Ukrainian technical regulations governing:
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general medical devices;
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in vitro diagnostic medical devices;
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active implantable medical devices.
The conformity assessment procedure and documentation requirements depend on the risk class of the device.
Typical documentation required for the procedure may include:
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technical documentation (technical file or technical specifications);
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instructions for use and product labeling;
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declaration of conformity issued by the manufacturer;
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authorization documents for the manufacturer’s representative in Ukraine;
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product descriptions and supporting documentation;
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documentation relating to quality management systems (where applicable).
Certain documents must be translated into Ukrainian before submission.
Registration of medicinal products
Medicinal products must undergo state registration before they can be marketed in Ukraine.
The documentation required depends on the registration pathway, which may include:
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accelerated registration or recognition of foreign registration;
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standard registration procedures for generic medicines;
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registration of original medicinal products;
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re-registration of previously registered medicines;
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amendments to the medicinal product dossier.
Registration procedures typically require extensive information regarding:
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the composition and quality of the medicine;
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manufacturing processes;
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pharmacological and toxicological data;
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clinical studies and supporting scientific evidence.
Our services in registration of medical devices and medicines
Our firm provides legal assistance in regulatory procedures for medical devices and pharmaceutical products in Ukraine, including:
Regulatory assessment and preparation
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analysis of regulatory requirements applicable to specific medical devices or medicines;
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preparation of document checklists and review of submitted documentation.
Registration procedures
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preparation and submission of applications for conformity assessment of medical devices;
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preparation and submission of applications for state registration of medicinal products.
Regulatory communication
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correspondence with competent regulatory authorities;
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preparation of responses to official requests during the review process.
Post-registration procedures
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assistance with re-registration of medicines;
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preparation and submission of applications for amendments to medicinal product dossiers.
Obtaining regulatory approvals
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legal support throughout the regulatory procedure until the necessary registration certificates or approvals are issued.
Our lawyers assist companies in bringing medical devices and pharmaceutical products to the Ukrainian market in compliance with regulatory requirements.