Ukrainian Scientific Institute of Certification

News

18/09/2018

Enforced change of conformity assessment body. Transfer procedure.

Dear participants of the 27th International Medical Exhibition ‘PUBLIC HEALTH 2018’!

This year, the National Accreditation Agency of Ukraine (NAAU) has canceled the accreditation and appointment of several bodies for assessing the compliance of medical devices. Manufacturers and distributors who placed their products on the market on the basis of certificates of these bodies are in extreme conditions of doing business because of lack of reliable information about the consequences of such actions.

For today, UNI-CERT is already carrying out the transfer procedure for several such certificates and is ready to share its experience so that affected manufacturers and distributors of medical devices can quickly take further response measures with a view to lawful business in Ukraine.

We invite you to take part in the seminar, prepared specially for the participants of the 27th International Medical Exhibition ‘PUBLIC HEALTH 2018’, dedicated to this actual topic.

Medical devices turnover by certificates of the body that has lost its accreditation and appointment

Change of conformity assessment body

PROGRAM

  • The grounds under which the conformity assessment body may lose its accreditation and appointment;
  • Approach to the transfer of certificates to the EU;
  • The validity of certificates of the body that has lost its appointment;
  • Risks related to the transfer of certificates to another body;
  • Change of conformity assessment body:
  •     sequence of actions when changing the conformity assessment body
  •     marking and turnover of products during the transfer period

Speaker:

Date and time of the seminar:  October 2th, 2018, Tuesday at 15:00–17.00.

Venue of seminar: International Exhibition Centre, pavilion №3, conference hall №15, Kyiv, 15 Brovarskyi Ave.

Working language of the seminar: Ukrainian / Russian / English

Cost of the seminar: free

Preliminary registration is obligatory:

Target audience of the seminar:  manufacturers and suppliers of medical devices to the Ukrainian market.