Medical Device Regulatory Services in Italy

With a growing demand for comprehensive medical devices, Italy stands as one of the largest medical devices market in Europe. The Directorate General for Medical Devices and Pharmaceutical Service of Ministry of Health is the competent authority responsible for regulating the import, marketing and trade of medical devices in the country. As a mandate, all Medical Devices must be registered with the Ministry of Health prior to their market entry, to obtain which, they must perform a CE certification conformity assessment submitting relevant technical documents. With no online registration system, application forms along with required documents must be submitted to Ministry of health via email or by post/ hand delivery.
Obtaining a CE Certification could prove challenging since it is a long process involving compilation of numerous documents as specified by the EU device laws. Freyr offers end-to-end Regulatory services for Medical Devices and authoritative Regulatory intelligence to decode the peculiar requirements and supports in dossier compilation for compliant submission.

Check out more at: Medical Device Regulatory Services in Italy

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