Ukrainian legislation requires every non-resident manufacturer to appoint an Authorized Representative.
An Authorized Representative is a legal or natural person (entrepreneur) who satisfies any of the following points:
Medical device package labeling and instructions for use must contain the information about the AR (name and address of the duly authorized representative). Each device has to be associated with only one authorized representative.
The authorized representative is obliged to keep documentary records for at least 5 years. Moreover, access to the documents must be available upon the request of public authorities and the conformity assessment body. In case of implantable medical devices, the documentation must be stored for at least 15 years.
How to indicate what MD’s are subject to self-declaration?
According to Technical Regulations on medical devices, class I medical devices, non-sterile and without a measuring functions are subject to self-declaration. In line with the Technical Regulations on medical devices for in vitro diagnostic, all MD’s which don’t fall under the list A and list B classification and are not intended for self-control are subject to self-declarationread more
Which act should govern a medical device with a medicinal substance?
The operation of medicines in Ukraine is covered by the Law of Ukraine «On Medicines». I have already defined in previous videos that MD’s are subject to Technical Regulations and other acts. And the Law of Ukraine «On Medicines» doesn’t cover on medical devices (neither in vitro diagnostic devices, nor active implantable devices).read more
I don’t have a conformity assessment certificate according to Technical regulations. Can I place on market a medical device without applying to the CAB to proceed a CAP?
Yes, you can put your MD into circulation in Ukraine without involving a CAB in one and the only case – your medical device is I class risk (non-sterile and without measuring function).read more
Is it possible to obtain a certificate without the on-site audit?
There are two options to proceed the CAP and to avoid on-site audit of the manufacturer: 1. Recognition of CE Certificate. 2. Proceeding batch certification.read more
Do I have to proceed with a CAP in Ukraine if I already have a CE Certificate?
The existence of CE Certificate doesn’t provide any preferences — Ukrainian legislation requires to proceed the conformity assessment procedure under the Ukrainian TR’s even for those manufacturers that possess a CE Certificate.read more
What regulations govern the conformity assessment procedure in Ukraine?
Since 1 July 2015, it has become
a mandatory requirement that medical devices, must be subject
to the assessment of conformity with the Technical regulations (TR) before being placed on the Ukrainian market.
Who is entitled to proceed the conformity assessment procedure of medical devices in Ukraine?
In accordance with the Law of Ukraine
“On Technical Regulations
and Conformity Assessment”,
the conformity assessment procedure
is made by the Conformity Assessment Body, an organization which confirmed its competence, proceeded
the accreditation procedure,
and therefore can perform conformity assessment.
What steps should I take in order to place a medical device on the Ukrainian market?
It depends on the class of medical devices you want to place on
As a general rule,
since July 1st, 2015 all suppliers
of medical devices in Ukraine must follow conformity assessment procedures with technical regulations on medical devices.