The industry of medical devices and medical equipment is one of the most innovative sectors of the global industry. Due to its primary purpose residing in the quality improvement of human lives and life expectancy increase, it is within the constant purview of the regulatory authorities.
We assist our clients in the ultimate achievement of their business objectives by virtue of our excellent awareness of dynamically changing market regulations, active stance on the protection of market interests in public organizations and state agencies, as well as the unique experience gained during the years of practice in this area.
In 2012-2014, Legal Alliance acted as a sole legal advisor of the Association of Market Operators of Medical Devices, which is the only specialized union of market members in Ukraine, in cooperation with which Legal Alliance participated in the drafting of amendments to the Laws of Ukraine, the Decrees of the Cabinet of Ministers of Ukraine, the Orders of the Ministry of Health of Ukraine regulating the activities of market operators of medical devices. Dmytro Aleshko, Legal Alliance Partner, occupied a position of the Vice-President of the Association of Market Operators of Medical Devices.
- Registration of a number of medical devices within the State Administration of Ukraine on Medicinal Products.
- Protection of the interests of the largest Eastern European manufacturer of enzyme immunoassay systems in the procedure of public procurements appeal at Antimonopoly Committee of Ukraine.
- Support of the projects on declaration and registration of prices for medicinal products and medical devices amounting to more than 1200 items.
- Development of the corporate structure, incorporation and further legal support of the Association of Market Operators of Medical Devices.
- Legal assessment of the sales scheme of orthopedic medical devices for British manufacturer of medical devices.
- Advisory assistance to national supplier of gynecology medical devices regarding the import of finished medical devices/raw materials for further manufacture of finished medical devices to the customs territory of Ukraine.
- Planning and implementation of a number of legal measures aimed at preventing the realization of counterfeit products in Ukraine for Danish manufacturer of medical devices.
- Advisory assistance to European pharmaceutical company with respect to medical devices marking with national conformity mark.
- Advisory assistance to a number of manufacturers of medical devices in the field of compliance and anti-corruption legislation.
- Advisory assistance on medical devices’ quality and safety control.
- Legal support of medical devices’ import and export procedures.
- Advisory assistance on medical devices distribution.
- Advisory assistance on intellectual property.
- Advisory assistance on tax issues and the optimization of the corporate structure.
- Advisory assistance on pricing, technical regulation requirements, labeling requirements, etc.
- Advisory assistance and legal support on the implementation of Technical Regulations on Medical Devices, consultations on active medical implants, medical devices for in-vitro diagnostics.
- Legal support of certification / declaration procedures for medical devices.
- Advisory assistance on national standards for medical devices, classes and modules for conformity assessment.
- Advisory assistance on competition law, advertising/promotion.
Policy making in the field of medical devices:
- Drafting of Resolution of the Cabinet of Ministers of Ukraine as of July 1, 2014, №216 “On Approval of the List of Medical Devices, Transactions on Supply of which within the Territory of Ukraine, and on Import of which to the Customs Territory of Ukraine are Subject to Value-Added Tax Payment at the Rate of 7 Per cent”.
- Participation in the drafting of the Cabinet of Ministers regulations in the field of public procurement of medicinal products and medical devices with the involvement of specialized international organizations, in particular: Resolution of the Cabinet of Ministers of Ukraine (CMU) № 622 as of July 22nd, 2015, "Certain Issues of the Public Procurement of Medicinal Products and Medical Devices Involving Specialized Organizations Carrying Out Procurements", CMU Resolution № 787 as of October 8th, 2015, "On Approval of the List of Medicinal Products and Medical Devices Procured According to Agreements for Procurement with Specialized Procuring Organizations".