Procedure of registration of medical devices, devices for in-vitro diagnostic in Ukraine which is called now – “conformity assessment to Technical regulations” came into force on 01 July 2015.
The sign of conformity assessment to Technical regulations is symbol which putted on the device, pointed in instruction for use or printed on the package.
This symbol on the medical device (MD) is the declaration of the manufacture that MD corresponds to main safety requirements, to human health and environment safety.
There are 3 Technical regulations for conformity assessment medical devices in Ukraine on present moment:
- for medical devices
- for in-vitro diagnostic devices
- for active implantable devices
Each Technical regulation describes the conformity assessment routes in accordance with potential class risk of MD, proposing to manufacture the different variants.
For conformity assessment procedure it is necessary to assign the authorized representative (AR). It must be the resident of Ukraine, legal entity. It might be separate firm or distributor. However it is recommended to split the commercial and regulatory activity, as the later is the direct responsibility of the manufacture and defined by quality policy which has not being affected by influence of commercial.
The next step for compliance assessment is the choice of organization which is authorized in this sphere and has the profile relevant to your MD. On this stage the customer would face with first difficulties, as he is not skilled and can’t answer on expert’s questions to understand for himself two main questions: the cost and time of compliance assessment procedure.
There is “simplified” scheme or route of compliance assessment of MD and in- vitro diagnostic devices. It is called self-declaration and it is applied for MD of I class risk (non sterile, non measure) and for in-vitro (non for self-control, out of list “A”, “B” in accordance with Resolution of Cabinet of Ministers of Ukraine No.754). However self-declaration does not exempt you from necessity of creation and maintenance of technical documentation in the correct manner (item 3, annex 8 of Technical regulation RCMU No.753).
For MD of IIa, IIb class risk there are following routes of compliance assessment.
Pict.1 Routes of compliance assessment of medical devices IIa class risk (Technical regulation Resolution of Cabinet of Ministers of Ukraine No.753)
Pict.2 Routes of compliance assessment of medical devices IIb class risk (Technical regulation Resolution of Cabinet of Ministers of Ukraine No.753)
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For sterile medical device of I class risk are applicable the routes of compliance assessment as for MD of IIa class risk: annex 3 or annex 8+6. For medical devices of III class risk there are possible routes of compliance assessment: annex 3+4; annex 4+5 (for non sterile MD); annex 4+6 (Technical regulation Resolution of Cabinet of Ministers of Ukraine No.753).
Technical file is the main document which submitted into compliance assessment body and it has to confirm any declaration of conformity for all annexes of Technical regulation. Its content depends from class risk of MD and choose route of conformity assessment. More detailed info about this document and its structure you can find in correspondent division of our site.
Have compiled technical file, picked up authorized body and defined with route of compliance assessment you may apply on this procedure.
Our company offers the complex solution on carrying out of registration procedure (conformity assessment) in Ukraine and provides the following services:
- provides consultancy for your MD and defines the optimal route for compliance assessment
- provides the service of authorized representative in Ukraine and prepares individual project of authorized representative agreement;
- submit on behalf of your name the application into compliance assessment body and determines the time and cost of implementation of this procedure;
- compiled technical file with minimum required divisions, provides translation of documentation on request of competent body;
- cures the notes on technical file, does actions on issue of required divisions if required (literature review, summary on clinical or pre-
- clinical safety, notes to file)
- organize the carrying out of tests and samples taking in case of assessment of medical device/lot.
- agrees the program and time for audit carrying out;
- takes part in cure of audit notes
- gets declaration of conformity
We offer operational efficiency, custom-tailored approach and reasonable prices for our service.