The conformity assessment procedure comprises any procedure used to determine that a medical device fulfills the Technical Regulation requirements and standards.
According to TRs, medical device classification (Class I, IIa, IIb, III, List A and B, etc.) defines the conformity assessment procedure. These procedures can include self-declaration, QMS audit, CE Certificate recognition, batch certification, etc.
The manufacturer is required to submit the technical documentation of a medical device (safety and performance claims) to the CAB. The depth of the technical documentation review conducted by the CAP is entirely dependent upon the classification of the device, as defined by the corresponding Technical Regulation.
In case of QMS audit, the CAB will determine the number of audit days and specific sites that should be inspected only after the complete draft application has been submitted.
Be aware that once the manufacturer has submitted a signed application, it is not allowed to provide the same request to any other CAB.
In Ukraine, the conformity assessment certificate of a medical device is valid for 5 years. Please note that the CAB of Ukraine will conduct annual audits throughout the validity period.
State regulation of prices for some goods and anti-epidemic goods: up-to-date.
On May 18, the Resolution of the Cabinet of Ministers of April 22, 2020 № 341 came into force, which defines the mechanism for declaring changes in retail prices for goods of significant social significance and anti-epidemic goods. Declaration of changes in retail prices is introduced in case of price increase, compared to the price […]read more
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
Who is the Authorized representative?
The essential requirement for the manufacturer which is not the resident of Ukraine, is to appoint the authorized representative.read more
What is the procedure of conformity assessment?
Conformity assessment procedure – any procedure used to determine that prescribed requirements in relevant technical regulations or standards are fulfilled.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.
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