Certificate of free sale process updates
18/02/2025 Regulatory newsWe recently updated our process for applying for certificates of free sale for medical devices. These changes include:
- One application form to be used for all certificate of free sale requests.
- New Excel device schedule, where the applicant should list all devices to be included on the certificate.
- Updated the information to be included on certificates of free sale template.
- New dedicated email address for application form submissions and queries relating to certificates of free sale, devicecerts@hpra.ie.
These process changes should create a more efficient process both for applicants and the HPRA. We envisage these changes will also reduce errors in applications, enable quicker validation checks and improve processing times. Full details on the updates can be found on our certificates of free sale webpage.
We would be grateful if you could familiarise yourself with the new application form and device schedule. Please forward this notification to any colleagues responsible for submitting certificate of free sale applications. We will now only accept applications for certificates of free sale using our updated forms.
All new certificate of free sale applications and queries should be sent to devicecerts@hpra.ie.