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Article

Guidelines for the submission of documentation for single technology assessments (STAs) of medical devices and diagnostic interventions

The Norwegian Institute of Public Health issues guidelines for the submission of documentation for single technology assessments (STAs) of medical devices and diagnostic interventions. The updated guidelines are valid from September 2021.

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The Norwegian Institute of Public Health issues guidelines for the submission of documentation for single technology assessments (STAs) of medical devices and diagnostic interventions. The updated guidelines are valid from September 2021.


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About single technology assessments

Single Technology Assessments (STA) is an evidence summary focusing on effectiveness, safety, and cost-effectiveness. The Commissioning Forum can commission STAs when medical devices, diagnostic methods, procedures and pharmaceuticals are processed within The National System for Managed Introduction of New Health Technologies within the Specialist Health Service. When STAs are commissioned, the manufacturer/supplier or a representative agent provide analyses and submit the relevant documentation.

Guidelines and template

The guidelines and associated template for submission should be used when preparing and submitting documentation for single technology assessments of medical devices and diagnostic interventions for decisions concerning public sector funding via the Specialist Health Service ("Nye metoder"). The updated guidelines are updated in accordance with the principles adopted in the Priority-setting White Paper.