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Which act should govern a medical device with a medicinal substance?

The Law of Ukraine on Medicines covers the operation of medicinal substances.

Medical devices are subject to Technical Regulations along with other acts. But, the Law of Ukraine on Medicines does not cover the medical devices (neither in vitro diagnostic devices nor active implantable ones).

Moreover, according to Technical Regulations on medical devices and active implantable devices, the ones that are used to deliver medicines to the body are regulated by the mentioned Technical Regulations.

In case, if a medical device with a constituent medicinal substance comprises a device for single use only and is implemented solely for the application in mentioned combination, it is subject to regulation under the Law of Ukraine On Medicines.

On the other hand, if a medical device contains as inalienable part a substance, which in case of its independent use can be considered as a medicine  and it’s influence to the body is additive toward the medical device, such a device is subject to Technical Regulations.

FAQ

s

How to indicate what MD’s are subject to self-declaration?

Comment

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-declaration

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Which act should govern a medical device with a medicinal substance?

Comment

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).

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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?

Comment

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).

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Is it possible to obtain a certificate without the on-site audit?

Comment

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.

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Do I have to proceed with a CAP in Ukraine if I already have a CE Certificate?

Comment

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.

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Who is the Authorized representative?

Comment

The essential requirement for the manufacturer which is not the resident of Ukraine, is to appoint the authorized representative.

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What is the procedure of conformity assessment?

Comment

Conformity assessment procedure – any procedure used to determine that prescribed requirements in relevant technical regulations or standards are fulfilled.

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What regulations govern the conformity assessment procedure in Ukraine?

Comment

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.

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Who is entitled to proceed the conformity assessment procedure of medical devices in Ukraine?

Comment

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.

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What steps should I take in order to place a medical device on the Ukrainian market?

Comment

It depends on the class of medical devices you want to place on
the market.
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.

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