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Ukraine Approves New National Recommendations for Medical Devices


Recently, the Ministry of Health of Ukraine issued the Order “On approval of Methodological Recommendations on Application of:

  • Technical Regulations on Medical Devices

  • Technical Regulations on medical devices for in vitro diagnostics

  • Technical Regulations regarding Active Implantable Medical Devices (AIMD)”.

According to this order, several methodological recommendations became effective in Ukraine. These recommendations are harmonized with the relevant MEDDEV guidance documents that clarify technical regulations for medical devices, medical devices for in vitro diagnostics, and AIMD.

Below, you can find the comparison table

These recommendations are not mandatory but should help companies to apply the technical regulations effectively.

The full text of the recommendations in Ukrainian you can find here.

The information has been prepared by the GMA Consult Group team. GMA Consult Group provides a full cycle of international type approval and global market access services for IT, Telecom and industrial electrical products in all countries throughout the world. With proven expertise in worldwide regulations, compliance, certification, and conformity assessment, GMA Consult Group can help your company speed up the access to any market with almost zero efforts from your side. Need your own guide to the world of certification and approvals? Don't hesitate to contact us via info@gma.trade.

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