Search results for 'labelling medical device Italy':
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medical device registration in italy - thema med
Labelling and documentation language. Documentation and labelling must be provided in Italian. Useful information. The site of the General Directorate of Medical Devices and the Pharmaceutical Service of the Ministry of Health is constantly updated.
“medical devices labelling: instructions for use”INTRODUCTION. The White Paper “Medical Devices Labelling: instructions for use” explains from a regulatory point of view what are the labelling requirements of Medical Devices according to the MDR (EU) 2017/745 Regulation. . duct label helps the user to identify and use it correctly. It contributes to high standards of q.
italy introduces new rules regarding medical devices and in vitro ...Online sale of devices. The Decrees identify the Ministry of Health as the competent authority responsible for monitoring and enforcing the safety of devices offered for online sale to the public – giving the Ministry the power to issue measures to prevent users from accessing websites deemed to be promoters of illegal practices.
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italy: new guidance on translation of labels and repackaging of medical ...On 18 August 2021, the Medical Device Coordination Group, composed of representatives of all Member States and chaired by a representative of the European Commission, published the guidance on procedures for the translation of labels and instructions for use, as well as the repackaging of medical devices.
medical device advertising in italy: is authorisation by the ministry ...The Directive 93/42/EEC concerning medical devices, implemented in Italy by Legislative Decree n. 46 of February 24, 1997 , did not provide for any specific discipline regarding the advertising of medical devices, leaving space to the individual legislators of the various countries of the European Union for its possible regulation.
the import of medical devices in italy - di renzo regulatory affairsThe labelling and the instructions for use must be necessarily written in Italian in order to import the medical devices in Italy.
search results for 'labelling medical device italy':May 24, 2019. 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. medical devices | european medicines agency. Medical devices are products or equipment intended for a medical purpose.