Training “Renewal of inspections of medical devices: what operators should prepare for and how to pass without fines. Dialogue with the regulator”

Details:

• 
  Date: November 1, 2024
• 
  Time: from 09:00 to 14:00 Kyiv time
• 
  Event adress: Online, Zoom
• 
  Language of the event: Ukrainian
• 
  Speakers:

  • Anna Hnatiuk, Conformity Assessment Specialist for Medical Devices and Head of Sector of the Authorized Representative of Cratia
  • Maksym Lovkin, Legal Adviser of Cratia
• 
  Cost:

  • 5900 UAH without VAT.
    Discount policy (discounts are not summarized):
    ● discount for group participation (from 2 or more participants) - 10%;
    ● special conditions for members of the Association of Medical Device Market Operators AMOMD® and Cratia customers - 15% discount.

In the event:

1. Reasons for inspections and legal grounds;
2. Responsibilities of national manufacturers and Authorized Representatives;
3. List of documentation to be provided during the inspection;
4. Procedure for passing inspections;
5. Labeling as the main source of nonconformities;
6. The most frequent non-compliances;
7. Liability, fines and corrective actions;
8. Review of court practice regarding decisions of market surveillance authorities and Antimonopoly Committee of Ukraine.

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