Self-declaration of medical devices
Self-declaration of medical devices is a process that allows manufacturers or authorized representatives to declare the compliance of medical devices with the technical regulations without an audit by a conformity assessment body.
This simplified approach to market entry helps reduce the time and costs associated with bringing products to market by including them in the Register of Responsible Entities for Medical Device Market Introduction (State Service of Ukraine for Medicines and Drug Control Register).
Who can use self-declaration?
What documents are required to enter medical devices in the Register?
Currently, registration in the State Service of Ukraine for Medicines and Drug Control Register is done electronically through the Service Recipient’s Cabinet. To register, you need to prepare:
- A power of attorney from the manufacturer to the authorized representative (for foreign manufacturers)
- A declaration of conformity of the medical devices with the relevant Technical Regulation
- A NOTICE of the inclusion of information in the Register of persons responsible for the market introduction of medical devices, active implantable medical devices, and in vitro diagnostic medical devices
- A confirmation letter from the conformity assessment body regarding the classification of the medical device
The State Service of Ukraine for Medicines and Drug Control may also require samples of medical device labeling, user instructions for consumers, and technical documentation for the medical devices. It is important to remember that all medical devices registered with the authorized representative must have technical documentation available to demonstrate upon request during market surveillance inspections by the State Service.
Support of self-declaration
We offer a full range of services for successful self-declaration of medical devices at every stage: from obtaining a letter from the conformity assessment body to registering with the State Service of Ukraine for Medicines and Drug Control. The Med Quality team will prepare the power of attorney, declarations, labeling samples, instructions for the Ukrainian market, and provide consulting throughout the registration process.
If you have any questions or would like to learn more about our self-declaration services for medical devices, please contact us. We will be happy to help you take the first steps toward a successful market entry!
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