The import licenseón for medical devices It is a legal requirement that is responsible for regulating the entry of this type of products into a country.ís from abroad, since it is a type of product that must comply with a series of safety regulations and standards that guarantee quality, and that, above all, guarantee consumer health. Therefore, It is not so easy to import this type of products..
In this case, This document is needed and must be provided by the competent health authority, once the corresponding evaluation has been carried outón and confirmationón that the products comply with the health and quality standards that areán current in the countryís of destiny. The license ensures that imported products are manufactured in controlled conditions and that are truly effective for the advertised purpose.
¿Whyé Import license is requiredón of health products?
The import licenseón of health products It is a fundamental control instrument for health authorities, having as its main objective to be able to guarantee the effectiveness, the safety and quality of the products that arrive at a país. in the great majoríto of the fathersíses, Importing and marketing health products without the corresponding license can lead to legal and criminal sanctions..
Without this license there will be noá guaranteeía that the imported product complies with local regulations, what can put the health of consumers at risk. At the same time, it allows importing companies to demonstrate that their products are safe and legal.ígreat, which helps to create greater confidence on the part of consumers and favors the company in question.ócan get a better reputationón.
¿It is possible to import medical products to Spainñwithout a license?
If imports of medical products are made without a license that arrive in Spainña, not to beá possible to introduce them into the país. It won't be possibleá dispatch the merchandiseíat Customs and, therefore, the products will haveán have to be destroyed or, failing that, returned to origin.
It is neither legal nor advisable to import health products to Spain.ñwithout the corresponding license. In fact, is the Espa Agencyñwave of Medicines and Health Products (AEMPS) It is the body that is in charge of regulating this type of imports, and that requires that all people who want to import this type of health products, must have an import licenseócorresponding n.
Nevertheless, keep in mind that esta regulationón applies in the majoríto of the fathersíses, not only in Spainña, so that theí It seeks to guarantee the safety and effectiveness of health products that are marketed in the countryís, so that the rights and health of consumers are duly protected.
Steps to import health products
Having said the above, We review the steps that must be followed to carry out the import.ón of health products to Spainña, what are the following:
- Documentóprovider no.. Before starting the importóIt is essential to be able to have all the informationón and documentationómanufacturer and/or supplier number, Therefore, it is advisable to be well advised in this regard to be able to follow the appropriate steps to import a product legally..
- Requirements témanufacturer technicians. Before proceeding with the importóto beá It is necessary to analyze that the manufacturer complies with the European Regulations that are applicable.ón in each particular case, so that those companies that do not manufacture in a safe way can be ruled out.
- Study of the regulations. It is necessary to carry out a report técynic in which it was evaluatedúand the product in questionón and everything is clear regarding its approvalón, además of being able to know whether or not it can be imported to Spainña. Thanks to this report beá possible to determine whaté products cannot be certified or sold at the Unión European.
- Importers license. As we have already mentioned, it is necessary to process the license with the Espa Agencyñwave of Medicines and Health Products (AEMPS) to theí to be able to proceed with its importationón, for which there will beá to comply with the different requirements demanded by the organization, providing all the documentationón téconical and the appropriate reports so that there is no problem when carrying out the import.ón of this type of products to Spainña.
- Import procedureón. Once said license is obtained,á It is necessary to implement the procedures required by the authorities and organizations to give the green light to the importation.ón of the medical device. For this there will beá to carry out different records to contribute as the selectionónumber of suppliers, the controls, the inspectionón, traceability, storage or collection of claims, among others.
- CE marking of the product. As required by current regulations, All documentation must be preparedón téconical shape required by European regulations and the corresponding product tests must be processed in order to enjoy the CE marking on it..
Secondly, keep in mind that Importers can only introduce into the Uni marketón European, products compliant with the European Medical Device Regulations. Además, All importers are responsible for verifying that the product has the CE market and that it has been manufactured under the declaration.ón EU product conformity; the manufacturer must be duly identified and have designated an authorized representative; The product must be labeled in accordance with the Health Products Regulation and be accompaniedñado of the instructions for use necessary for its safe use. in your case, the manufacturer willá assigned to the product an identifier único.
If an importer considers or has reason to think that a product does not comply with the requirements of the European Regulation, I won't be able toá put it on the market until it has been brought into compliance, and informá to the manufacturer and the corresponding authorized representative of this.
in addition, when the importer considers that the product presents a serious risk or isá counterfeit, tenderá to inform the competent authority of the State member in which it is established.
