Search results for 'labelling medical device Italy':

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 italy introduces new rules regarding medical devices and in vitro ...
The prohibition of advertising to the public of custom-made devices, of devices for which the use requires the assistance of a doctor or a health professional (either by law or by the manufacturer’s guidelines), and of devices requiring a doctor’s prescription; The need for authorization by the Ministry of Health for all other cases.

 italy: new guidance on translation of labels and repackaging of medical ...
On 18 August 2021, the Medical Device Coordination Group (MDCG), 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.

 white paper medical devices labelling: instructions for use - thema med
Thema Srl. www.thema-med.com. 23/04/2021/ 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.



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 italy’s new device-vigilance network: how to prepare for it
Italy has recently instituted substantial changes in national regulations on medical device vigilance in order to align our procedures with European Regulations 2017/475 for medical devices and 2017/476 for in vitro diagnostics.

 medical device registration in italy - thema med
Medical Device Registration in Italy. Regulatory Authority. Direzione Generale dei Dispositivi Medici e del Servizio Farmaceutico – Italian Ministry of Health. Classification. Class I (non-sterile, without measuring function), Class I (sterile, with measuring function), Class IIa, Class IIb, Class III. Quality system. ISO 13485:2016.

 a guide to enter your medical device in italy | regdesk
A Guide to Enter Your Medical Device in 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. In the European Union (EU) they must undergo a conformity assessment to demonstrate they meet legal requirements to ensure they are safe and perform as intended.




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