The import license for medical products is a legal requirement that regulates the entry of these products into a country from abroad. Medical products must comply with a series of safety standards and regulations to ensure their quality and protect consumer health.
This document is granted by the competent health authority after evaluating and confirming that the products meet the current health and quality standards in the destination country. The license ensures that the imported products are manufactured under controlled conditions and are effective for the intended purposes.
Why is it necessary to have an import license for medical products?
The import license is an essential control instrument for health authorities. Its main objective is to guarantee the safety, efficacy, and quality of the products imported into the country. In most countries, importing and marketing medical products without the corresponding license can result in legal and penal sanctions.
Without this license, there is no guarantee that the imported product complies with local regulations, which can pose a risk to consumer health. At the same time, it allows importing companies to demonstrate that their products are safe and legitimate, increasing consumer confidence and contributing to the company’s good reputation.
Can medical products be imported to Spain without a license?
Importing medical products without a license will mean that the goods cannot be cleared through customs and, consequently, the products will have to be destroyed or returned to the origin.
It is neither legal nor advisable to import medical products into Spain without the corresponding license. The Spanish Agency for Medicines and Health Products (AEMPS) is the body responsible for regulating such imports and requires all companies wishing to import medical products to have an import license.
This regulation applies not only to Spain but also to most countries. The purpose of this requirement is to ensure the safety and efficacy of medical products marketed in the country, and to protect the health and rights of consumers.
Bull Importer is a company authorized by AEMPS. With us, you can import medical products offering multiple advantages. We facilitate the importation of all class I, II, and III medical products, and in vitro diagnostics, without requiring the hiring of specific personnel or the availability of an approved warehouse. As an importer, Bull Importer ensures the product’s compliance with regulations, oversees the entire process, and verifies all necessary documentation. Additionally, we offer a clear final price, including all import costs in a single invoice, and provide a comprehensive and secure service with more than 27 years of experience. With Bull Importer, you can repeat the process as many times as you want without incurring fixed costs or claims.
