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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?

Yes, you can launch your medical device on the Ukrainian market without involving a CAB only in case if your medical device falls under the Class I category (non-sterile and without measuring functions). In this case, placing a product on the market is possible after providing self-declaration.

Self-declaration is the procedure whereby the manufacturer declares that the products concerned meet the provisions of the Technical regulation. The manufacturer must prepare technical documentation, declaration of conformity and file these documents to the State Service of Ukraine on Medicines and Drugs Control.

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).