Regulatory Representation

Helping when spectrum of jurisdictions rhymes with local presence…

LOK may act as your independent regulatory representative through its local offices. All of our representation services are offered by service partners who are well established in their own jurisdictions and ensure that all regulatory responsibilities and interests of our customers are handled professionally, confidentially, cost effectively and promptly.

We offer (in each jurisdiction):

  • EU Authorized Representative (EAR)
  • US Agent
  • Israel Registration Holder (IRH)
  • Russia Authorized Representative (RAR)
  • Assistance to build Technical Files
  • Operational assistance to labels
  • Keeping, maintaining and updating your technical  files
  • Official European notification/registration of devices
  • Incident analysis and incident classification
  • Incident reporting
  • Recall (withdrawal) notification