Legislation

To successfully launch a product to the market and maintain its certification, timely respond to remarks or questions, you should be familiar not only with industry legislation but also be well conversant in the regulatory enactments applicable to your products. Below, only the main documents concerning Technical Regulations on medical devices and non-food products in Ukraine are listed:

1. Law of Ukraine “On Technical Regulations and Conformity Assessment Procedures”;

2. Law of Ukraine “On State Market Surveillance and Control of Non-food Products”;

3. Law of Ukraine “On General Safety of Non-Food Products”;

4. Law of Ukraine “On the Protection of Consumer Rights”;

5. Technical Regulations on medical devices:

• Resolution No. 753 of the Cabinet of Ministers of Ukraine dated October 2, 2013, “On Approval of the Technical Regulations on Medical Devices”;
• Resolution No. 754 of the Cabinet of Ministers of Ukraine dated October 2, 2013, “On Approval of the Technical Regulations on Medical Devices for In-Vitro Diagnostics”;
• Resolution No. 755 of the Cabinet of Ministers of Ukraine dated October 2, 2013, “On Approval of the Technical Regulations on Implantable Medical Devices”.

6. Technical Regulations which can also be applicable to the medical devices:

• Technical Regulations on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment approved by Resolution No. 139 of the Cabinet of Ministers of Ukraine dated March 10, 2017.
• Technical Regulations on Radio Equipment approved by Resolution No. 355 of the Cabinet of Ministers of Ukraine dated May 24, 2017.

7. Resolution No. 1184 of the Cabinet of Ministers of Ukraine dated December 30, 2015, “On Approval of the Form, Description of the Mark of Conformity to the Technical Regulations, Rules and Conditions for Its Application”.

8. Order No. 122 of the Ministry of Health of Ukraine dated February 10, 2017, “On Approval of the Procedure for Maintaining the Register of Persons Responsible for the Introduction of Medical Devices, Active Implantable Medical Devices and Medical Devices for In Vitro Diagnostics, Reporting Forms, List of Information Stored in It, and the Mode of Access to Them”.

9. Order No. 142 of the Ministry of Health of Ukraine dated January 22, 2020, “On Approval of Instructional Guidelines on the Application of the Technical Regulations on Medical Devices Approved by Resolution No. 753 of the Cabinet of Ministers of Ukraine dated October 2, 2013, the Technical Regulations on Medical Devices for In Vitro Diagnostics approved by Resolution No. 754 of the Cabinet of Ministers of Ukraine dated October 2, 2013, and the Technical Regulations on Active Implantable Medical Devices Approved by Resolution No. 755 of the Cabinet of Ministers of Ukraine dated October 2, 2013”.

10. Order No. 1245 of the Ministry of Health of Ukraine dated October 11, 2017, “On Approval of the List of National Standards, Compliance with Which Provides a Presumption of Compliance of Medical Devices with the Requirements of the Technical Regulations on Medical Devices”.

11. Order No. 1243 of the Ministry of Health of Ukraine dated October 11, 2017, “On Approval of the List of National Standards, Compliance with Which Provides a Presumption of Compliance of Active Implantable Medical Devices with the Requirements of the Technical Regulations on Active Implantable Medical Devices”.

12. Order No. 1242 of the Ministry of Health of Ukraine dated October 11, 2017, “On Approval of the List of National Standards, Compliance with Which Provides a Presumption of Compliance of Medical Devices for In Vitro Diagnostics with the Requirements of the Technical Regulations on Medical Devices for In Vitro Diagnostics”.

13. Order No. 117 of the Ministry of Health of Ukraine dated January 20, 2020, “On Amendments to Some Orders of the Ministry of Health of Ukraine”.