Export Certification – Certificate of Free Sale for Medical Devices
A manufacturer or authorised representative located in Ireland can apply for a certificate of free sale.
The HPRA issues certificates of free sale under two legislative frameworks:
All applications must be submitted electronically to email@example.com. Depending on the type of device, please supply a Conformity Assessment certificate, Full Quality Assurance certificate and a Declaration of Conformity or your HPRA registration numbers where applicable. Proof of payment should also be attached to avoid delay and inconvenience.
Product codes / UDI / Notified Body Certificate numbers etc. submitted on the application form should exactly match registered or approved product codes. New or updated product codes / UDI / Notified Body Certificate numbers etc. must be supported by a letter on the company’s letter headed paper and signed by a member of senior management. The letter should list the new or updated products.
When applying for a certificate of free sale, proof of manufacture must be provided in the form of a letter. This letter is a statement made by the manufacturer on the company’s letter headed paper, signed by a designated representative. This is in addition to any proof of manufacture required from the notified body.
For more information, please see the Guide to Applications for Certificates of Free Sale for Medical Devices.
Application forms are available to download using the following links:
A standard set of four certificates are issued. Additional certificates can be requested at the time of the initial submission.
Further information in respect of fees for human products and payment details are included in the documents below:
Due to the current public health pandemic, the offices of the HPRA are currently closed with limited access per week for members of the export certificates team to facilitate printing and wet signing of certificates. Therefore all applications for certificates will unfortunately face delays in processing.