21 Dec How do I obtain a certificate of free sale for medical devices?
One of the novelties we are offering this month for our customers is assistance in obtaining a certificate of free sale for the export of a medical device. What are they? How are they obtained? we have prepared a post where we explain it to you.
What is a certificate of free sale?
It is a document addressed to companies established in Spain to export medical devices outside the European Union. This document certifies that the product to be exported complies with Spanish and European legislation.
To verify this compliance, the certificates and the manufacturing licence must be sent to the AEMPS. In this way, the Agency confirms that the products are registered and comply with European regulations. Validate that the CE certificate is correct.
Who issues this licence?
The AEMPS issues these documents, which certify that the medical device is legally marketed in the European Union. Likewise, manufacturers can apply for the free sale certificate from ICEX Spain Export and Investment.
Who can apply?
Any company or self-employed person who imports, manufactures, distributes, groups or sterilises medical devices, as well as authorised representatives.
What requirements does the product have to meet?
It must have been legalised in the Member State in which the licence is applied for. In Spain, in order to obtain this certificate, the product must have the CE marking. In other words, products must comply with European legislation and be licensed for manufacture or import.
To export a Class I product, the company must be entered in the register of marketers. In addition, for class II devices onwards and some in vitro devices, the communication of the placing on the market of the medical devices must be made.