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Submission of documentation for health technology assessment of medical devices

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The Norwegian Medical Products Agency (NoMA) assesses medical devices for use in specialist healthcare.

Health technology assessments are commissioned by the national system for the introduction of health technologies in the specialist healthcare services (“Nye metoder”). These assessments inform decisions on implementation of a technology in the specialist healthcare. 

We conduct various types of health technology assessments. The single technology assessments are based on documentation provided by the device manufacturer (or their representative). NoMA will contact the manufacturer when we are commissioned this type of assessment. The manufacturer will conduct the analyses and send relevant documentation to NoMA for appraisal. Only medical devices that carry the CE mark of conformity are eligible for assessment.

For instructions on documentation, and guidelines and templates for submission, please contact NoMA at hta.medical.devices@noma.no

We accept submissions in English, Norwegian, Danish and Swedish. Submissions should be sent to post@noma.no and hta.medical.devices@noma.no.