WTO notification · TBT
UkraineAdopted, according to its latest notice
Official title
Draft Resolution of the Cabinet of Ministers of Ukraine 'On Approval of the Technical Regulation on Medical Devices'
Ukraine issued an addendum on 19 June 2026 to the earlier TBT notification G/TBT/N/UKR/320. Addenda often report that a measure was adopted, changed, postponed or withdrawn. The measure was first notified on 19 November 2024. The comment period closed on 6 December 2025.
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Medical devices
Latest notice (G/TBT/N/UKR/320/Rev.2/Add.1, 19 June 2026)
The latest notice says the measure was adopted or published.
Draft Resolution of the Cabinet of Ministers of Ukraine 'On Approval of the Technical Regulation on Medical Devices'
Ukraine notifies the adoption of Resolution of the Cabinet of Ministers of Ukraine No. 759 'On Approval of the Technical Regulation on Medical Devices' of 10 June 2026. The Resolution was published on 18 June 2026 and will enter into force six months after its publication, i.e. on 18 December 2026, except for clauses 3 and 4 thereof, which will enter into force on 31 December 2030. The Technical Regulation approved by this Resolution will take effect on 31 December 2030, except for: clauses 234 and 235, which will take effect on the date Ukraine becomes a Member State of the European Union.
the draft Resolution provides for the update of the provisions of the Technical Regulation on Medical Devices, developed on the basis of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. The draft Technical Regulation on Medical Devices sets requirements for medical devices and clarifies the responsibilities of manufacturers, authorised representatives, importers and distributors. It establishes requirements for conformity assessment bodies, strengthens governmental supervision over their activities, modifies the classification rules for certain medical devices and expands the scope of application. A new provision also regulates the distance selling of medical devices through information and communication systems (including via the Internet) and introduces reinforced requirements for clinical evaluation and clinical investigations, post-market surveillance and post-market clinical follow-up, as well as safety monitoring by manufacturers and the competent authorities. A Unique Device Identification (UDI) System is being introduced to ensure traceability of medical devices, enhance monitoring efficiency and reduce the risks of medical errors and counterfeiting. Each medical device will have a unique UDI code identifying the manufacturer, device type, device number or…
Every notice about this measure published here, newest first. Each one is the notifying member's own text.
AddendumG/TBT/N/UKR/320/Rev.2/Add.1
Draft Resolution of the Cabinet of Ministers of Ukraine 'On Approval of the Technical Regulation on Medical Devices'
Ukraine notifies the adoption of Resolution of the Cabinet of Ministers of Ukraine No. 759 'On Approval of the Technical Regulation on Medical Devices' of 10 June 2026. The Resolution was published on 18 June 2026 and will enter into force six months after its publication, i.e. on 18 December 2026, except for clauses 3 and 4 thereof, which will enter into force on 31 December 2030. The Technical Regulation approved by this Resolution will take effect on 31 December 2030, except for: clauses 234 and 235, which will take effect on the date Ukraine becomes a Member State of the European Union.
RevisionG/TBT/N/UKR/320/Rev.2
Comment deadline: Closed on 6 December 2025
Draft Resolution of the Cabinet of Ministers of Ukraine 'On Approval of the Technical Regulation on Medical Devices'
the draft Resolution provides for the update of the provisions of the Technical Regulation on Medical Devices, developed on the basis of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. The draft Technical Regulation on Medical Devices sets requirements for medical devices and clarifies the responsibilities of manufacturers, authorised representatives, importers and distributors. It establishes requirements for conformity assessment bodies, strengthens governmental supervision over their activities, modifies the classification rules for certain medical devices and expands the scope of application. A new provision also regulates the distance selling of medical devices through information and communication systems (including via the Internet) and introduces reinforced requirements for clinical evaluation and clinical investigations, post-market surveillance and post-market clinical follow-up, as well as safety monitoring by manufacturers and the competent authorities. A Unique Device Identification (UDI) System is being introduced to ensure traceability of medical devices, enhance monitoring efficiency and reduce the risks of medical errors and counterfeiting. Each medical device will have a unique UDI code identifying the manufacturer, device type, device number or…
RevisionG/TBT/N/UKR/320/Rev.1
Comment deadline: Closed on 6 July 2025
Draft Resolution of the Cabinet of Ministers of Ukraine 'On Approval of the Technical Regulation on Medical Devices'
The draft Technical Regulation sets out rules for placing on the market, making available on the market or putting into operation of medical devices intended for human use and accessories for such devices. It also applies to clinical investigations concerning such medical devices and their accessories conducted in Ukraine. The draft Technical Regulation aims to remove legal, administrative and technical barriers in the field of medical devices, while ensuring the safety and efficacy of medical devices on the Ukrainian market, implementing modern European approaches to monitoring the safety and efficacy of medical devices and preventing the entry of unsafe, ineffective and counterfeit medical devices into Ukraine. This draft Technical Regulation has been developed based on Regulation (EU) No 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Once adopted, the Technical Regulation will take effect in five years after its publication. Until then, the current Technical Regulations on Medical Devices and on Active Implantable Medical Devices will remain fully applicable. To facilitate the transition to the new requirements, specific transitional periods will be introduced. It is also noted that placing on the market of medical devices that comply with the requirements of the Technical…
Regular notificationG/TBT/N/UKR/320
Comment deadline: Closed on 18 January 2025
Draft Resolution of the Cabinet of Ministers of Ukraine 'On Approval of the Technical Regulation on Medical Devices'
The draft Technical Regulation sets out rules for placing on the market, making available on the market or putting into operation of medical devices intended for human use and accessories for such devices. It also applies to clinical investigations concerning such medical devices and their accessories conducted in Ukraine. The draft Regulation aims to remove legal, administrative and technical barriers in the field of medical devices, while ensuring the safety and efficacy of medical devices on the Ukrainian market, implementing modern European approaches to monitoring the safety and efficacy of medical devices and preventing the entry of unsafe, ineffective and counterfeit medical devices into Ukraine. This draft Regulation has been developed based on Regulation (EU) No 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.
Expodite writes its summary from the official record. The notification and the documents it notifies are on the WTO's own websites.
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