Search results for 'labelling medical device Italy':
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a guide to enter your medical device in italy | regdesk
Medical devices in Italy are subject to the same regulations as all countries in the European Union (EU) which were implemented in 2017. Here, you can find out more information on the EU MDR and IVDR regulation. However, there are slight differences in the regulatory requirements that vary between each country within the EU.
italy - whoMedical devices regulatory systems at country level June 2015 - April 2016. ... inadequacy in Labelling or on any technical or medical related defect that lead to a manufacturer’s ... result in death or serious harm placed on the market in Italy, then it must inform the Ministry of Health. Decreto Legislativo 24 febbraio 1997, ...
medical device registration in italy - thema medManufacturers intending to market CE-marked medical devices in Italy and European Authorized Representatives, in the case of devices produced by Manufacturers established outside the European Union, must register with the Ministry of Health database and notify some technical data of the device, according to specific online forms for the purpose of their inclusion in the medical devices Repertoire.
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medical devices: regulatory obligations in italyMany pieces of information should be entered into the database, including name and code of the medical device, its classification (class, GMDN code, etc.), name of the Manufacturer or its authorized representative, a brief description of the medical device together with its intended use, a list of the materials contained in the medical device that comes into direct contact with the patient ...
eu medical device labelling requirements | clever complianceMedical Device Labelling Requirements. A label represents the written, printed or graphic information appearing either on the medical device itself, or on the packaging of each unit or the packaging of multiple medical devices. Manufacturers must ensure that their product labels bear all the following elements to avoid non-compliance:
database and repertorio – medical device registration in italyThe database of medical devices collects information related to all medical devices released in the Italian territory by domestic manufacturers. However, the registration of medical devices by European or non-European manufacturers who wish to distribute their medical devices in Italy is limited to those belonging to classes higher than I.
fda labelling requirements for medical devices: an overviewMedical Device Labelling: Overview of FDA regulations. The FDA requirements for labelling of medical devices are embedded with Quality System Regulation requirements mentioned in 21 CFR Part 820.This includes activities for labelling control, incoming control of materials (including labelling) and design documentation to ensure labels have adequate space on the device and packaging.