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Regulatory information for medical devices/in-vitro diagnostic medical devices

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Ophthalmic Devices; Reclassification of Ultrasound Cyclodestructive Device

From Food and Drug Administration (FDA) 🇺🇸

May 20, 2024

Expression of Interest for Medical Device Registration Voluntary Feasibility Study

From South African Health Products Regulatory Authority (SAHPRA) 🇿🇦

May 17, 2024

Medical devices regulations: compliance and enforcement

From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧

May 17, 2024

Q&As on conditions of supply for rapid antigen point of care COVID-19 tests

From Therapeutic Goods Administration (TGA) 🇦🇺

May 16, 2024

Guide to Clinical Investigations carried out in Ireland

From Health Products Regulatory Authority (HPRA) 🇮🇪

May 16, 2024

FOI disclosure log

From Therapeutic Goods Administration (TGA) 🇦🇺

May 16, 2024

COVID-19 rapid antigen self-tests (for home use)

From Therapeutic Goods Administration (TGA) 🇦🇺

May 16, 2024

COVID-19 point-of-care tests

From Therapeutic Goods Administration (TGA) 🇦🇺

May 16, 2024

Breast Implant Expert and Consumer Working Groups

From Therapeutic Goods Administration (TGA) 🇦🇺

May 16, 2024

Legal supply of COVID-19 test kits

From Therapeutic Goods Administration (TGA) 🇦🇺

May 16, 2024

Vigilance

From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭

May 16, 2024

Clinical trials

From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭

May 16, 2024

Safety information

From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷

May 17, 2024

Recalls and safety alerts

From Health Canada 🇨🇦

May 17, 2024

List of recalls and other field safety corrective actions (FSCA)

From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭

May 17, 2024

Safety Alerts on Medical Devices

From Ministry of Health (Italy) (MDS) 🇮🇹

May 17, 2024

Safety announcements from medical device manufacturers

From Danish Medicines Agency (DKMA) 🇩🇰

May 16, 2024

Alerts

From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷

May 15, 2024

Medical Device Recalls

From Food and Drug Administration (FDA) 🇺🇸

May 15, 2024

Alerts and recalls of medical products - ANMAT

From National Administration of Drugs, Food and Medical Devices (ANMAT) 🇦🇷

May 14, 2024

Medical Devices Safety Notices

From Health Products Regulatory Authority (HPRA) 🇮🇪

May 13, 2024

Weekly reports of the National Center for Medical Devices and Products Reporting

From Saudi Food and Drug Authority (SFDA) 🇸🇦

May 12, 2024

Product Recalls

From National Medical Products Administration (NMPA) 🇨🇳

May 8, 2024

Recalls of medical devices

From National Organization for Medicines (EOF) 🇬🇷

April 30, 2024

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