Webinar “Conformity assessment of medical devices in Ukraine in a nutshell. Key information for foreign manufacturer”

Details:

• 
  Date: November 14, 2023
• 
  Time: from 16:00 to 18:00 Kyiv time (GMT +2)
• 
  Event adress: Online
• 
  Language of the event: English
• 
  Speakers:

  • Maksym Bagrieiev, CEO Cratia
• 
  Cost:

  • Free, subject to prior registration

In the event:

1. Requirements for placing of medical devices on the market of Ukraine;
2. Non-medical technical regulations that can apply to medical devices;
3. Authorized representative: it's functions and responsibilities;
4. Classes of medical devices and types of conformity procedures;
5. Documents required for conformity assessment;
6. National documents and forms: labeling, instructions, checklist, declaration, application;
7. Use of electronic instructions;
8. Registration of class I and IVD "other";
9. Audits and CE certificate recognition;
10. Maintenance of certification;
11. Market surveillance;
12. Exemptions for humanitarian aid.