Speaker covered the following topics:
- Overview of Ukrainian Technical Regulation No 753 on medical devices: Introduction, scope and applicability of the regulation; Key principles and goals of the regulation.
- Conformity Assessment Procedures for medical devices in Ukraine: Overview of pathways of conformity assessment: from self-declaration to recognition and on-site audits
- Self-Declaration Procedure: Requirements for self-declaration and local authority for registration of medical devices
Recognition Procedure: Explanation of the recognition procedure accordig to Law of Ukraine on Conformity Assessment; - Documentation requirement and steps involved; Benefits and challenges of the recognition procedure.
- On-site Audits vs Remote Audits: Circumstances under which remote or on-site audits are conducted; Preparation for audits: documentation and specific requirements; Advantages and limitations of remote and on-site audits.
The webinar provided valuable insights into navigating Ukraine’s regulatory landscape for medical devices, empowering manufacturers with the knowledge to choose the most suitable conformity assessment pathway for their products, prepare effectively for audits, and ensure compliance with Ukrainian law.
Webinar recording available via this link, and Vladyslav’s presentation via this link.
The Training Events Plan for August 2024 is available on our website. We invite you to review and participate in the upcoming events.
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