{"id":1473,"date":"2021-02-25T13:52:13","date_gmt":"2021-02-25T13:52:13","guid":{"rendered":"https:\/\/www.igo.it\/cosa-significa-essere-officina-presidi-medico-chirurgici\/"},"modified":"2021-03-05T17:02:02","modified_gmt":"2021-03-05T17:02:02","slug":"what-does-being-a-medical-and-surgical-device-manufacturer-entail","status":"publish","type":"post","link":"https:\/\/www.igo.it\/en\/what-does-being-a-medical-and-surgical-device-manufacturer-entail\/","title":{"rendered":"WHAT DOES BEING A MEDICAL AND SURGICAL DEVICE MANUFACTURER ENTAIL?"},"content":{"rendered":"

Medical and Surgical Device is a particular category of products defined by Italian regulations, to be precise by article 1 of Italian Presidential Decree n. 392 of 6 October 1998.<\/strong><\/p>\n

According to this decree, Medical and Surgical Devices category includes disinfectants and germicides\/bactericides, insecticides for domestic and civil use, insect repellents and rodenticides for domestic and civil use.<\/strong><\/p>\n

Considering that this type of product can potentially cause harm to people and the surrounding environment, their manufacture is heavily regulated.<\/p>\n

The main active ingredients used must be included on a list drawn up on a European Community level that contains not only the substances authorised, but also the conditions for their use.<\/strong> There are currently 23 types of biocides, organised into 4 groups.<\/p>\n

The products commercialised also have to carry a special label<\/strong> that indicates both the type of Medical and Surgical Device and whether it is a disinfectant or a biocide, and another label displaying the product registration number issued by the Ministry of Health.<\/p>\n

Medical and Surgical Devices can only be manufactured by companies with Ministry of Health authorisation, defined as Medical and Surgical Device Manufacturers.<\/strong><\/p>\n

As well as this authorisation, companies carrying out this activity must also provide the Ministry of Health with technical documentation regarding the products before they can be released on the market<\/strong>, containing information regarding the identity of the active ingredient, its properties, safety assessments for people and the environment, and its effectiveness as a biocide.<\/p>\n

All of these measures guarantee product effectiveness, people\u2019s health and environmental protection.<\/strong><\/p>\n

IGO has been recognised as a Medical and Surgical Device Manufacturer with Medical and Surgical Device decree n. 28\/2004 dated 09\/08\/2004, meaning it has more than 15 years\u2019 experience in biocide manufacture.<\/strong><\/p>\n

The entire IGO production chain is certified, from the mixing of active components with solvents and fragrances to impregnation and the application of compounds onto a range of evaporation substrates, right up to the final packaging of products ready for sale.<\/p>\n

Find out more about our complete service for the contract production of biocides.<\/strong><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Medical and Surgical Device is a particular category of products defined by Italian regulations, to be precise by article 1 of Italian Presidential Decree n. 392 of 6 October 1998. According to this decree, Medical and Surgical Devices category includes disinfectants and germicides\/bactericides, insecticides for domestic and civil use, insect repellents and rodenticides for domestic […]<\/p>\n","protected":false},"author":357,"featured_media":1471,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[24],"tags":[],"yoast_head":"\n\n\n\n\n\n\n\n\n\n\n\n\n\t\n\t\n\n\t\n