Basic obligations for suppliers of health care devices Standard obligations for authorised Associates of health care devices Basic obligations for importers and distributors of healthcare products General obligations for health institutions when applying clinical units Cases in which obligations of makers implement to importers, distributors or other folks Pieces and components that modify overall performance or meant purpose Promoting for clinical products Scientific investigation of professional medical equipment
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Introduction to scientific investigations of healthcare products Scientific investigations which have to have an software Medical investigations which need a notification Other clinical investigations Protection reporting in clinical investigations Sizeable modifications to a clinical investigation Finish or short term halt of the medical investigation Medical investigations started out just before twenty sixth May perhaps 2021 Functionality scientific tests of in vitro-diagnostic medical gadgets (IVDs)
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Introduction to general performance research of IVD medical units Overall performance scientific studies which have to have an application Effectiveness scientific studies which demand a notification
On the other hand, there are various exemptions to your or else comprehensive ban, like marketing in foreign printed media if the most crucial goal with the advertising and marketing or foreign printed media is not the Norwegian current market, and manufacturer stretching. Other kinds of marketing and marketing, including direct man or woman-to-person focusing on of individuals, probably slide outdoors the scope of your ban.
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On arrival to Norway, EU/EEA citizens can carry a total quantity of one yr’s value of e-cigarette oils or liquids for intake. Non-EU/EEA citizens are permitted a complete of 3 months’ value of e-cigarette solutions.
Medical trials of human medicines Approval and upkeep of promoting authorisation (MA) Disinfectans - approval, manufacturing and import Adverse drug reactions and drug safety
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With the ban on e-cigarette sale and importation however active, this plan remains inapplicable until July one, 2023. Once enacted, remote sale of e-cigarette merchandise will be restricted to registered entities permitted through the Directorate of Health and fitness.
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