Brazil
The National Health Surveillance Agency (ANVISA) of Brazil has announced changes in the regulations on Class II medical devices. The devices are allowed to be placed on the market under simplified (notification) procedure providing that it is sufficient for the...
COVID-19
The Saudi Food & Drug Authority (SFDA), the regulating authority in the sphere of medical devices in Saudi Arabia, has published a guidance document dedicated to the requirements for unique device identification (UDI) for medical devices. The present document...
FDA
The Food and Drugs Administration (FDA), the US authority responsible for medical device regulation, has published a guidance document dedicated to the annual reports for Pre-market Approval Applications (PMA) that have been approved. Regulatory Background According...
Australia and Oceania
The Therapeutic Goods Administration (TGA) provided a set of detailed guidance documents to assist medical device manufacturers in achieving and sustaining compliance with regulatory requirements to be allowed for marketing in Australia – the Australian...
FDA
The Food and Drug Administration (FDA) has published the draft guidance dedicated to the principles for selecting, developing, modifying, and adapting patient-reported outcome instruments for use in medical device evaluation. Scope of the guidance According to the...
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