Italy Medical Device Registration

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Registering medical devices in the national database

https://www.salute.gov.it/portale/temi/p2_6.jsp?id=5715&area=dispositivi-medici&menu=registrazione

The medical devices sector is undergoing a transitional period in which some provisions set out by Regulation (EU) 2017/745 (MDR), such as the registration of economic operators …

Italy - Medical Device Registration (NSIS)

https://omcmedical.com/italy-medical-device-registration-nsis/

In Italy, the manufacturer must register the medical devices in a dedicated database of the Ministry of Health before they are put into the market. The obligation to register with the …

Italy - Medical Devices and Technology - International …

https://www.trade.gov/country-commercial-guides/italy-medical-devices-and-technology

A Guide to Enter Your Medical Device in …

https://www.regdesk.co/italy-reg/

Medical devices in Italy are subject to the same regulations as all countries in the European Union …

Medical Device Registration in Italy - Thema Med

https://www.thema-med.com/en/medical-device-registration-italy/

Medical Device Registration in Italy. Medical Devices shall bear the CE marking and they are subject to registration with the Italian Ministry of Health database. In the case of a …

Italy Medical Device Registration - NSIS Approval

https://arazygroup.com/medical-device-registration-italy/

Medical Device Regulations and Classification in Italy. REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. In Italy, …

Italian Device Registration - Wikipedia

https://en.wikipedia.org/wiki/Italian_Device_Registration

The manufacturer should register their products through their Italian distributor who is not only familiar with the language and local regulations but also has responsibility if he is the …

National Registration - Obelis Group

https://www.obelis.net/services/healthcare/national-registration/

Registration Process In accordance with the Law on Medical Devices, adopted by the Bulgarian Parliament during its session on June 12, 2007, and as promulgated in the …

Italian Medicines Agency

https://www.aifa.gov.it/en/web/guest/home

13 Feb 2023 Lists of Class A and Class H medicinal products List of class A and H medicinal products at 20 September 2022 AIFA makes available, to healthcare …

Step 7. Register the device and the manufacturer

https://eumdr.com/step-7/

Register the device and the manufacturer – The European Union Medical Device Regulation Step 7. Register the device and the manufacturer Registration has …

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