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- Application for conformity assessment of products
- Supplement A to the application for conformity assessment of products
- Supplement B to the application for conformity assessment of products
Ukrainian Certification Agency is an authorized conformity assessment authority to assess compliance with the requirements of the Technical Regulations on Medical Devices.
Appointment of the authorized conformity assessment authority to assess compliance with the requirements of the relevant technical regulations – Order of the Ministry of Economy of 24 February 2017 No. 265.
Identification number: UA.TR.121.
From 1 July 2015, assessment of compliance with the requirements of technical regulations approved by Decrees of the Cabinet of Ministers No. 753, No. 754, No. 755 of 02.10.2013, is an obligatory requirement for introduction and/or use of medical devices into/on the market of Ukraine.
The transition period from state registration of medical devices to conformity assessment ended on 1 July 2017, was completed. As a result, from 2 July 2017, all medical devices should be validated (legalized) in the territory of Ukraine exclusively by way of assessment of compliance with the requirements of technical regulations.
From 2 July 2017, medical devices (other than custom-tailored or intended for clinical researches) should be marked with the national conformity mark prior to introduction. The marking must be clearly visible, legible and should not be erased. Along with the national conformity mark, the identification number of the conformity assessment authority should be indicated.
The compliance assessment method is selected taking into account medical device classification and following compliance assessment procedures in line with the Technical Regulations on Medical Devices.
Representatives of Ukrainian Certification Agency will gladly help with filling-in an application and correctly selecting the compliance assessment procedure, as well as advise of all legal aspects related to relevant services.
In an applicant files a signed application to the conformity assessment authority, he/she cannot file a similar application to another conformity assessment authority at the same time.
For more detailed information, please visit our “Contacts” page and contact us in the manner most convenient for you.
Application of the national conformity mark on products
According to the technical regulations on medical devices, on medical devices intended for diagnosis in vitro, on active implantable medical devices, approved by the Cabinet of Ministers of Ukraine of October 2, 2013, No. 753, No. 754, No. 755 respectively, it is established that after carrying out all necessary procedures prior to introduction of medical products into the market, the national mark of conformity to technical regulations should be applied on medical products for all risk classes (other than custom-tailored or intended for clinical researches).
The national mark of conformity to technical regulations is applied, at the manufacturer's decision, on the medical device or its packaging, as well as on the instruction for use, if such instruction is mandatory. The mark of conformity to technical regulations should be visible, legible and should not be erased. The national conformity mark may be applied on the label of the medical device.
Along with the conformity mark, the identification number of the conformity assessment authority (if any) is indicated, as follows:
The mark of conformity to technical regulations is applied in accordance with the form approval, conformity mark description, and rules and conditions for its application, approved by the Decree of the Cabinet of Ministers of Ukraine of 30 December 2015, No. 1184.
The mark of conformity to technical regulations (hereinafter referred to as the conformity mark) has the form of the circle unclosed on the right side with the stylized shamrock image inside. The rapture length is 0.22 of its total length (or 80 degrees).
The conformity mark image can be flat or texturized and in two contrasting colors.
The conformity mark height should not be less than 5 millimeters, unless otherwise provided by the relevant technical regulations.
If the mark is made smaller or bigger, the aspect ratio should be maintained.
The conformity mark size cannot be less than 5 millimeters. The specified minimum size may be reduced for small-sized devices.
The mark of conformity to the technical regulations is applied on the product or on its technical data plate so that it is visible, legible and indelible. Is this is impossible or unreasonable due to the product nature, the conformity mark sis to be applied on the packaging and accompanying documents, if such documents are provided for by the relevant technical regulations.
Rights and obligations of the applicant