Cabinet of Ministers Resolution as of march 23, 2016, № 240 “On Amendments to Certain Resolutions of the Cabinet of Ministers of Ukraine” has been published on the official website of Ukrainian Government.
The Resolution introduces changes to 3 Technical Regulations on Medical Devices:
1) CMU Resolution as of October 2, 2013, № 753 “On Approval of Technical Regulations on Medical Devices”;
2) CMU Resolution as of October 2, 2013, № 754 “On Approval of Technical Regulations on Medical Devices for it vitro Diagnostics”;
3) CMU Resolution as of October 2, 2013, № 755 “On Approval of Technical Regulations on Active Implantable Medical Devices”.
The abovementioned governmental Resolution extends the transition period by 01.07.2017. During this period all medical devices shall be introduces to the market and put into operation on the basis of acting certificate of state registration.
Thus, the document provides for the following: “Introduction into market and/or operation of medical devices, registered and incorporated into State Register of Medical Equipment and Medical Devices, and approved for usage in Ukraine, which have been put into operation before the date of obligatory adherence to Technical Regulations, shall be allowed without any compliance assessment and marking with national quality standard mark”.
These medical devices are allowed for market distribution before their expiry date and not later than 5 years from the date of their sales start without the compliance assessment and national quality standard mark.
Based on the abovementioned, the compliance assessment procedures shall become obligatory starting from July 1, 2017 for registered medical devices with the unlimited state registration certificate or with the certificate expiring after this date. Registered medical devices with the certificate expiring after July 1, 2017, should undergo the compliance assessment procedures after the expiration of such certificate in order to stay on the market.
Another significant change introduces the opportunities to conduct the compliance assessment procedures during the period of validity of medical devices registration certificate.
Moreover, certain changes have been introduced into the registration of the officials responsible for putting medical devices into operation.
In view of this, CMU Resolution foresees the liability to report to State Administration of Ukraine on Medicinal Products the location and the list and description of medical devices for the following entities:
In case such entity is not a resident of Ukraine, the authorized representative should be assigned with the responsibility to introduce such medical devices into Ukrainian market.
State Administration of Ukraine on Medicinal Products should maintain a Register of entities responsible for the introduction of medical devices into the market. Ministry of Health of Ukraine should approve the corresponding register maintenance procedures, report forms, the list of data stored in the register, and information access procedures.
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