Saudi Arabia The Saudi Food and Drug Authority (SFDA), Saudi Arabia`s medical device regulating authority, has published a guidance document on requirements of shipments clearance at ports of entry. The document is intended to provide additional information on compliance matters...
FDA The Food and Drug Administration (FDA) has published a discussion paper dedicate to the cybersecurity vulnerabilities associated with medical devices. In particular, the document describes the best practices to be considered when communicating with the healthcare...
IMDRF The International Medical Device Regulators Forum (IMDRF), a voluntary association of medical device regulating authorities collaborating on the improvement of the legislative framework has published a position paper describing the proposed approach to the post-market...
FDA The Food and Drug Administration (FDA), the US regulating authority, has published guidance describing technical considerations for non-clinical assessment of medical devices containing nitinol. The present document constitutes a final version of the draft guidance...
Australia and Oceania The Therapeutic Goods Administration (TGA) of Australia has published a notice describing the approach to delays in medical device conformity assessment recertification. The document is intended to address the issues related to the outbreak of COVID-19 caused by the...
FDA The Food and Drug Administration (FDA) has published draft guidance on updates for biocompatibility of certain devices in contact with intact skin. Notes The public consultations period commenced on October 15, 2020, and would last for 60 days during which the...
