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

There are two options to proceed with a CAP through avoiding the on-site manufacturer audit:

Recognition of the CE Certificate
Proceeding with batch certification

Batch certification does not imply the full certification procedure or the on-site manufacturer inspection. Instead, a certificate shall be issued for each batch of the produced goods. This procedure comprises sampling batch products and testing them through any accredited laboratory. The applicant is free to choose the laboratory but has to pay the designated fee for the testing. Before selecting the laboratory, it is essential to identify the parameters and standard conditions under which the MDs should be examined for safety and quality.

In case if regular shipments of MD in Ukraine are planned, the batch certification is not justified as troublesome.

FAQ

State regulation of prices for some goods and anti-epidemic goods: up-to-date.

Comment

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 […]

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

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).

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).