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SQA Regulatory Surveillance Summary for May and June 2024

SQA

The EC engaged Gesundheit Österreich GmbH (Austrian National Public Health Institute), Civic Consulting, and Areté to collect data on the availability of medical devices in the EU and the progression of transitions to the Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR).

FDA 52
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SQA Regulatory Surveillance Summary for May and June 2024

SQA

The EC engaged Gesundheit sterreich GmbH (Austrian National Public Health Institute), Civic Consulting, and Aret to collect data on the availability of medical devices in the EU and the progression of transitions to the Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR).

FDA 40
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SQA Regulatory Surveillance Summary for January and February 2024

SQA

A health professional, in the context of a directed donation, did not create a document stating that, in their medical opinion, the use of sperm or ova would not pose a serious risk to human health and safety. Now the Ministry of Health has published revised regulations in accordance with Annex M of the Drugs and Cosmetics Rules.

FDA 40