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

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Medical devices and IVDs

From Therapeutic Goods Administration (TGA) 🇦🇺

May 20, 2024

Ophthalmic Devices; Reclassification of Ultrasound Cyclodestructive Device

From Food and Drug Administration (FDA) 🇺🇸

May 20, 2024

Instructions for sponsors who have interest in supplying a COVID-19 self-test

From Therapeutic Goods Administration (TGA) 🇦🇺

May 20, 2024

EU MDR Transition web publication service

From Therapeutic Goods Administration (TGA) 🇦🇺

May 20, 2024

COVID-19 testing in Australia: information for health professionals

From Therapeutic Goods Administration (TGA) 🇦🇺

May 20, 2024

COVID-19 test kits included in the ARTG for legal supply in Australia

From Therapeutic Goods Administration (TGA) 🇦🇺

May 20, 2024

COVID-19 home use tests

From Therapeutic Goods Administration (TGA) 🇦🇺

May 20, 2024

Applying for TGA assessment of a COVID-19 test for inclusion in the ARTG

From Therapeutic Goods Administration (TGA) 🇦🇺

May 20, 2024

Slide Template for IMDRF Membership Application Presentations

From International Medical Device Regulators Forum (IMDRF) 🌍

May 20, 2024

Announcements

From Ministry of Food and Drug Safety (MFDS) 🇰🇷

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

Product Recalls

From National Medical Products Administration (NMPA) 🇨🇳

May 20, 2024

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

From Saudi Food and Drug Authority (SFDA) 🇸🇦

May 20, 2024

Safety Alerts on Medical Devices

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

May 20, 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 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

Recalls of medical devices

From National Organization for Medicines (EOF) 🇬🇷

April 30, 2024

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