New Updates to HPRA Certificate of Free Sale Process

The National Competent Authority of Ireland, Health Products Regulatory Authority (HPRA), has updated the application certificate of free sale process for medical devices.

These updates aim to streamline the application process and enhance efficiency by reducing errors, enable quicker validation checks, and improve processing times.

Key Updates to HPRA Certificate of Free Sale Process:

• • Unified Application Form: A single application form is now required to be used for all certificate of free sale requests.
  • New Excel Device Schedule: Applicants must list all devices to be included on the certificate in a new Excel schedule.
  • Updated Certificate Template: The information required on the certificates of free sale has been revised.
  • Dedicated Email Address: A new email address (devicecerts@hpra.ie) has been established for submitting application forms and handling related queries.

Full details on the updates can be found here: Certificate of free sale process updates.

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