National Medicine devices and medіcation registers

Situation (Problematic)

We have already implemented both registers in accordance with Ukrainian legislation, however, since Ukraine is a candidate for EU accession and is preparing for accession, the government is actively harmonizing our processes with European ones. In particular, a critical issue in the field of health care is the regulation of the spheres of medicines and medical devices.

Our Solution

Our solution involved developing two key registries: one for medical devices and another for medicines. These systems were crafted to meet the EU’s stringent regulatory standards, ensuring streamlined processes and data uniformity. And we are currently developing solutions that meet the latest regulations in this area: Regulation (EU) 2017/745, Regulation (EU) 2017/746 for devices, Directive No. 2001/83/EU, Regulation (EU) No. 520/2012 for drugs. In particular, we are gradually implementing ISO IDMP for medicines and UDI/BUDI for medical devices, which very few countries have done so far. We are focused on implementing EUDAMED guides and on PMS Guide from EMA in our solution.

Business Results

Our interventions led to:

• Compliance Mastery: Achieving full compliance with EU directives well ahead of the 2027-2028 deadline, setting a benchmark in Europe.
• More than 250k Medical devices in the register.
• More thаn 12k medicines in the register.
• Registers integrated to the other eHealth solutions as ePrescription, etc.

In summary, our endeavour in Ukraine’s healthcare ICT has been instrumental in modernizing medical services and product management, setting a high new standard for regulatory compliance and operational efficiency. Our comprehensive experience, culminating in the development of these vital registries, not only addresses Ukraine’s immediate healthcare challenges but also offers a replicable model for global health systems.

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