Want your free sale cert out of Ireland? More back-up docs but keep application short
This article was originally published in Clinica
Medical device companies applying for certificates of free sale to export their products from Ireland are now expected to submit more documents but must keep their application to a limit of 30 pages, instead of the previous 35 pages, according to revised guidance from the Irish Health Products Regulatory Authority.
The guideline outlines the documentation and information the HPRA needs to issue certificates of free sale to exporters of general medical devices, active implantable medical devices and in vitro diagnostics. The certificates are used by medtech companies that want to register, or renew the registration, of their device in third countries (outside the European Economic Area) or to accompany a shipment of that product.
The guideline has been revised to clarify additional documentation that companies will have to submit with their applications. These documents include:
- full quality assurance certificate - When making the first request for a certificate of free sale, companies must provide a copy of a current notified body certificate for the relevant devices, and should forward updated versions of the current notified body certificates or new notified body certificates for new devices to the HPRA. The guidance has been updated to clarify that the full quality assurance certificate listing sites of manufacture and address of European authorized representative should also be included. It states that notified body certificates for quality management systems are not sufficient. The HPRA states that these certificates should routinely be included in electronic format in future applications noting the expiry date and relevance to the products listed in the application;
- proof of place of manufacture of the device; and
- a copy of the Companies Registration Office (CRO) certificate issued to the company.
- In addition, the guideline has been updated to clarify that the HPRA may ask companies to submit: declaration of conformity; copy of the label, packaging and instructions of use (in all languages requested by the countries where the device is marketed); the agreement/contract between the manufacturer and European authorized representative (if applicable) which should include reference to responsibility for the post-market surveillance process and data, vigilance reports and complaints, processes and data. These documents have to be submitted only if requested by the agency.
Also, the updated guideline clarifies that applications which have been on hold for a month and where requested information has not been received shall be deemed invalid.