Conformity assessment for medical devices
We help your medical business meet standards and successfully launch products on the Ukrainian market.
Procedure of conformity assessment
In order to import and sell medical devices in Ukraine, it is necessary to undergo a conformity assessment procedure, which is determined in accordance with the Technical Regulations
THE CHOICE OF REGULATIONS DEPENDS ON THE TYPE OF PRODUCT:
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General medical devices
CMU Resolution No. 753
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In vitro diagnostic devices
CMU Resolution No. 754
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Active implantable medical devices
CMU Resolution No. 755
Methods of conformity assessment
Assessment procedures depend on the risk class and product characteristics.
WE OFFER SEVERAL OPTIONS FOR DIFFERENT TYPES OF PRODUCTS:
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Self-declaration
Used for low-risk products.
The manufacturer or his authorized representative prepares technical documentation, fills out a checklist and draws up a declaration of conformity. It is important to note that the declaration does not require additional confirmation by the conformity assessment body.
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Conformity assessment by audit
For products with a higher risk
The procedure involves a visit of auditors to the manufacturer to check the quality management system. The audit is carried out by the Ukrainian conformity assessment body, which, upon successful completion, issues a certificate valid for 5 years. Based on the certificate, the manufacturer draws up a declaration of conformity
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Recognition of the results of the European notified body
If there are appropriate agreements between the Ukrainian and European bodies, the results of conformity assessment can be recognized
This reduces the amount of necessary procedures and costs, but the Ukrainian certificate is valid only for the period of validity of the European certificate.
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