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The registration of medical devices in the databases

WEBAs of 26 May 2021, Regulation (EU) 2017/745, replacing and repealing Directive 93/42/EEC will apply to medical devices. The requirements provided for by the Regulation also …

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URL: https://www.direnzo.biz/it/en/medical-device-list/

Registration of MDR compliant medical devices: the Italian MoH …

WEBThe database for medical devices of the Italian Ministry of Health has been object of important updates these days: indeed starting from 01/12/2021 the registration of …

Category: Medical Go Health

New Italian guidelines for food supplements

WEBThe Ministry of Health has published some updated guidelines on food supplements in its website. In particular, maximum amounts of vitamins and minerals were reviewed along …

Category: Supplements, Food, Vitamin Go Health

Medical devices authorisations by way of derogation

WEBOn 16 February 2023, the Ministry of Health has published the memorandum letter “Operating Procedures for the Application of Authorisation by way of Derogation as per …

Category: Health Go Health

Caffeine: claims and admitted quantities in food supplements in Italy

WEBThe Ministry of Health published a memorandum letter to define the maximum intake limit for caffeine as well the properties associated with this ingredient that can be claimed in …

Category: Health Go Health

Medical apps: healthcare medical devices

WEBThe use of technology in the healthcare sector is spreading more and more, especially now that the COVID health emergency has imposed distance, and has limited physical …

Category: Health Go Health

New registration methods for manufacturers of customized …

WEBAs provided for by article 7 of Legislative Decree 5 August 2022, no. 137, the data indicated in the registration application must be updated within 30 days in case …

Category: Health Go Health

Food supplements: a reminder on notifications

WEBThe Ministry of Health also assesses the notifications received (both for new products and for variations of food supplements previously notified). If the product receives a positive …

Category: Supplements, Food Go Health

Regulatory and pharmaceutical consultancy

WEBRegulatory Consultants. Di Renzo Regulatory Affairs is a leading company in the field of regulatory consulting, with nearly 40 years of experience. The services offered concern …

Category: Health Go Health

Database and Repertorio – Medical Device Registration in Italy

WEBRegistration into the MD and IVD database. The Decree of the Ministry of Health 20 February 2007 has set up the new database of medical devices (MDs), to collect data …

Category: Medical Go Health

Online notification for special food and food supplements

WEBThe Ministry of health has reminded all concerned operators that since 2 nd July the notification of the products classified as food for special groups, gluten-free products …

Category: Food Go Health

Antifraud stickers and traceability of medicines

WEBDrug traceability, antifraud stickers and serialisation. Drug traceability has been created in order to collect, in a centralised database, information regarding the packs of medicines …

Category: Medicine Go Health

Certificate of Suitability to the monographs of the European

WEBThe Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) has been developed by the EDQM ( European Directorate for the Quality of Medicines) to …

Category: Medicine Go Health

Notification and registration dietary supplements

WEBNotification process. In Italy, it is possible to market food supplements only after their telematic notification to the Ministry of Health. This also applies to food supplement …

Category: Supplements, Food Go Health

Food Supplements and Brexit

WEBAs of 2021, United Kingdom is no more a Member of the European Union; the Brexit transition period has in fact concluded on 31 December 2020. The consequences on …

Category: Health Go Health

The import of medical devices in Italy

WEBTherefore the medical devices are imported in Italy only when they come from countries located outside the European Union. The medical devices undergo vigilance activities, …

Category: Medical Go Health

Botanicals and Dossier. Rules for using plants in supplements

WEBThe dossier of products containing botanicals is therefore an essential requirement for the marketing of food supplements containing herbal substances: it is an Italian requirement …

Category: Supplements, Food Go Health

Orthotics and insoles: Are they medical devices

WEBThe CE marking is provided for also on insoles and orthotics requiring to be adjusted by users (for instance, by cutting them to fit their shoes). This kind of insoles and orthotics …

Category: Health Go Health

Pharmacovigilance and possible organisation

WEBNine years have elapsed from the implementation of directive 2010/84, that deeply changed Pharmacovigilance management. In all these years, Regulatory agencies and …

Category: Health Go Health

Online procedure updated for food subject to notification

WEBThe Ministry of Health has published a note to clarify the actions to be taken for the products notified up to 2014. The products involved are those classified as food …

Category: Food Go Health

Food supplements: electronic notification, marketing and FSC

WEBThe company responsible for a food supplement is the FBO ( Food Business Operator) that markets the supplement and notifies its label to the Ministry of Health. In this context, in …

Category: Food Go Health

Free Sale Certificate

WEBFree Sale Certificate. This section refers to a category of certificates regarding different types of products, such as medicinal products for human and veterinary use, medical …

Category: Medical Go Health