Since number of medical devices is increasing exponentially, there is a need for close monitoring of safety and performance of medical devices registered and placed in Serbian market.

Vigilance of medical devices is in general in compliance with EU requirements, but however there are local regulations which cover vigilance field. All representatives in Serbia must appoint local person responsible for vigilance and market surveillance of medical device, and that is why is important to have reliable partner who can offer valid guidance and expertise.

Polifarm provides full vigilance and market surveillance services.
Here are some of them:

  • Vigilance:
    • • Establishing and maintenance of local vigilance system
    • • Full time (24/7) vigilance service, local vigilance responsible person availability
    • • In-time Incident report
    • • Field Safety Notice (FSN)
    • • Field Safety Corrective Action (FSCA)
  • Market Surveillance:
    • • Post-Market Surveillance Report (PMSR)
    • • Periodic Safety Update Report (PSUR)

Upon request, Polifarm also provides high quality expert translations from English to Serbian and vice versa.

Upon special request, Polifarm also offers local medical literature screening.

Described activities on certain level depend on medical device class.

Feel free to contact us for more information.

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