Public Health 2024: Seminar “Registration of medical devices”

Details:

• 
  Date: October 2, 2024
• 
  Time: from 14:00 to 17:30 Kyiv time
• 
  Event adress: Offline, IEC, 15 Brovarsky Avenue, Kyiv
• 
  Language of the event: Ukrainian
• 
  Speakers:

  • Viktoriia Moroz, Key Account Manager of Cratia
  • Mykola Matlaev, Lead Auditor of the Conformity Assessment Department of the Ukrainian Scientific Institute of Certification, Uni-Cert LLC
• 
  Cost:

  • Free for exhibitors and visitors of the Public Health exhibition

In the event:

1. Pathways to legalize products: own or contract manufacturing? national or imported?
2. Own trademark: benefits, opportunities, investments and risks;
3. OBL-OEM scheme for medical devices: quality or price? how to become a virtual manufacturer? what are the criteria for selecting suppliers?
4. Purpose of medical devices and classification;
5. Scenarios of conformity assessment for different types of medical devices: analysis of examples and options;
6. Self-declaration: what is needed? how quickly and what medical devices need to be registered?
7. Technical documentation: who and what documents should be developed?
8. Authorized representative of the manufacturer in Ukraine: role and duties;
9. Implementation of changes: new product line? new clinical data or updated instructions?
10. Market surveillance and responsibility.
11. Conformity assessment body (CAB): when to involve, what documents to provide and how to conduct audits;
12. Responsibilities and requirements for the manufacturer, Authorized Representative, importer, distributor, etc;
13. Medical devices to be certified;
14. Procedure with audit (remote / on-site);
15. Recognition of certificates by the EU;
16. Documentation analysis: what are the most common issues? Correction and approval of documents;
17. Maintenance of certificates, annual surveillance and recertification: what do you need to know in advance?
18. License agreement and its violation: suspension and revocation of certificates, reporting to the CAB.
19. Answers to questions from participants and visitors.

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