Search results for 'labelling medical device Italy':
Below is the list of the relevant search results found for the keyword 'labelling medical device Italy':
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italy - labeling/marking requirements - international trade administration
according to the classification, labelling and packaging of hazardous substances (clp) regulation (regulation 1272/2008), a label of dangerous substances must indicate the name of the substance; the origin of the substance, specifically, the name and address of the manufacturer or distributor; the danger symbol and an indication of danger …
medical device registration in italy - thema med
manufacturers 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 …
search results for 'labelling medical device italy':
italy - labeling/marking requirements - international trade administration The dimensions of the label must not be less than a standard A8 sheet of paper (52 mm x 74 mm), and each symbol must cover at least one-tenth of the label’s surface area. More results: the import of medical devices in italy - di renzo regulatory affairs
the import of medical devices in italy - di renzo regulatory affairs
The medical devices undergo vigilance activities, performed by the “ Uffici di Sanità Marittima, Aerea e di Frontiera ” ( USMAF-SASN and relevant territorial units) of the Italian Ministry of Health if they are imported from a third country, since they are goods of health interest.
a guide to enter your medical device in italy | regdesk
The biggest suppliers of medical devices to the Italian market include United States, France, Germany, Belgium, and the Netherlands. The highest demand for medical equipment includes areas like: high frequency medical lasers, home care equipment, remote monitoring equipment, anesthesiology equipment, and stimulators and defibrillators.
packaging law in italy calls for labelling obligations – ecosistant
Obligation for environmental labelling of packaging in Italy Decree No. 116 of 3 September 2020 obliges actors along the supply chain to label packaging materials. In short, it makes environmental labelling mandatory on all packaging in Italy. The aim of the decree is to reduce the impact of packaging and packaging waste on the environment.
medical devices: regulatory obligations in italy
In Italy, the Manufacturer (or its authorized representative in Europe) must register the medical devices in a dedicated database of the Ministry of Health before they are put into the market. The same requirement applies also to medical device kits, that must be registered into the same database by the Assembler.