Export Certification - Certificate of Free Sale for Medical Devices

A Manufacturer, Authorised Representative or Legal Manufacturer can apply for a certificate of free sale provided they are located in Ireland. There are three types of certificates of free sale which are issued depending on the medical device product or products.

The three types are:

  • General Medical Device (GMD)
  • Active Implantable Medical Device (AIMD)
  • In-vitro Diagnostic (IVD)

The content of each certificate will vary depending on whether the devices are CE marked or non-CE marked and whether the applicant is a manufacturer, authorised representative or legal manufacturer. All applications must be submitted electronically to exportcerts@hpra.ie. 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 submitted on the application form should exactly match registered or approved product codes. New or updated product codes 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.

If it is your first time applying for a certificate of free sale, proof of manufacture must be provided in the form of a notarised document. A notarised document is a statement made by the manufacturer on the company’s letter headed paper, signed by a designated representative and stamped and signed by their local public notary.

Please see the Guide to Applications for Certificates of Free Sale for Medical Devices and anApplication for Certificate of free sale for medical devices.

A standard set of four certificates are issued. A standard or fast track service is available.

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 inlcuded in our.