In order to protect public health, shipments of goods of medical interest imported from third countries and arriving at the international entry points of the Italian territory are subject to controls by the National Medical Authority.
The supervisory activity is performed to ascertain the compliance of goods of sanitary interest with the requirements and the prescriptions foreseen by the national and community regulations. Persons eligible to apply for such certificates are “Importers or Legal Representatives”.
The supervisory activity ends with the final issuance of an import admission decision or with a provision of non-admission to importation in the event of failure to pass the checks.
In order to apply, an Importer or Legal Representative needs to submit a request for health authorization to import. The documentation accompanying the goods must be attached to the online request – except when the current legislation on the matter provides for the delivery of original documentation.
The documentation accompanying the request for release of the Certificates varies according to the current legislation and depending on the type of goods or products the Importer or Legal Representative is intending to import.
If you would like more information on Italian Sanitary Certificates, please don’t hesitate to contact us! Obelis will be delighted to assist you thanks to our 30 years of expertise in the field of European Compliance for Medical Devices, Cosmetics and IVDs.