ASSESSMENT OF COMPLIANCE WITH TECHNICAL REGULATIONS

IMPROVE MEDICAL LLC is an authorized body for conformity assessment with the Technical Regulations for Medical Devices.

The identification number UA.TR.120 was assigned.

Corresponding Orders No. № 1898, №1899, 1900 of the Ministry of Economic Development of Ukraine dated 11.11.2016

Decisions №1898, №1899, №1900 of the Ministry of Economic Development of Ukraine

The authority of the company extends to assessing the conformity of products with the following Technical Regulations:
N 753 “On Approval of the Technical Regulations for Medical Devices”
N 754 “On Approval of the Technical Regulations for Medical Devices for In Vitro Diagnostics”
N 755 “On approval of the Technical Regulations on active medical devices that are implanted”

To receive the Cost of work on the Conformity Assessment with the Technical Regulations of Medical Devices, you need to provide the required list of documents, as well as completed forms. See links below.

Required list of documents from the manufacturer of medical devices.

Application for Conformity Assessment of TR for Medical Devices
Application for a design review of a medical device (TR 753)
Application for verification of the design of a medical device for in vitro diagnostics (TR 754)
Application for design verification of an active medical device that is implantable (TR 755)

Send the completed forms and the required list of documents to us at improvemedua@gmail.com.

Our experts will need only one day to prepare a solution and calculate the work.
If you have any questions regarding the choice of the Conformity Assessment procedure and filling out the forms, please call us at +38 044 355 50 30. Improve Medical experts will always be happy to inform you about the application of Ukrainian legislation in the field of technical regulation.

Determine the class of the medical device