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Finland updates device regulations in line with new law

This article was originally published in RAJ Devices

Executive Summary

Finland's National Supervisory Authority for Welfare and Health, Valvira, has issued four administrative orders regulating the procedures for medical device incident reporting, registration and clinical trials, in line with new medical devices legislation that came into force earlier this year1. The updated rules, which are expected to help manufacturers and other stakeholders better understand the various requirements, came into effect on 15 September.

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Finland updates device regulations in line with new law

Finland's National Supervisory Authority for Welfare and Health, Valvira, has issued four administrative orders regulating the procedures for medical device incident reporting, registration and clinical trials, in line with new medical devices legislation that came into force earlier this year1. The updated rules, which are expected to help manufacturers and other stakeholders better understand the various requirements, came into effect on 15 September.

Finnish legislation to separate device and pharma regulation

The Finnish president has submitted to parliament a bill that would separate the regulation of medicines and medical devices1. Passage of the legislation will make official the government’s earlier decision to transfer the regulation and market surveillance of devices from the National Agency for Medicines to the National Supervisory Authority for Welfare and Health (Valvira), located in Helsinki2.

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