Webinar “Fundamentals of conformity assessment for medical devices. Must-have for importer, Authorized Representative, and manufacturer”


  • Date: November 7, 2023
  • Time: from 12:00 to 14:00 Kyiv time (GMT +2)
  • Event adress: Online
  • Language of the event: Ukrainian
  • Speakers:
    • Viktoriia Moroz, Key Account Manager
  • Cost:
    • Free, subject to prior registration

In the event:

  1. What is required to place medical devices on the market and put them into service;
  2. How the class of the medical device impacts the certification procedure;
  3. Procedure types: self-declaration, audit, CE recognition, batch certification;
  4. Other "non-medical" technical regulations that may be applicable to medical devices;
  5. Authorized representative of the manufacturer in Ukraine: role, duties, responsibilities;
  6. What documents are required for conformity assessment;
  7. National documents: labeling, instruction, check-list, declaration;
  8. Registration of class I and IVD "other";
  9. Audit and recognition of the CE certificate;
  10. Market surveillance.
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We professionally perform registration of medicines, conformity assessment of medical devices, certification of cosmetics, disinfectants and special food products in Ukraine.
Our partners, international corporations and national manufacturers can best tell about our expertise and quality of work. For more than 15 years of work we have performed works for:

  • more than 150 manufacturers of medicines and active substances,
  • more than 800 manufacturers of medical devices and equipment,
  • more than 300 manufacturers of special food products and cosmetics.
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