US FDA CDRH Warning Letters: A Review of 2024
Medical device manufacturers who want to better understand U.S. FDA warning letters should read our regulatory insight.
US FDA CDRH 2024 Annual Report Summary
Medical device manufacturers can read our summary of the 2024 Annual Report recently released by the U.S. FDA’s Center for Devices and Radiological Health.
US FDA Rules for Notification of Discontinuation or Meaningful Interruption in Manufacturing
The U.S. Food & Drug Administration has finalized guidance requiring manufacturers to notify it of discontinuations or meaningful interruptions in manufacturing for many devices during, or in advance of, a public health emergency.
Australian TGA Expands EU Transitional IVDR Arrangements for New Inclusion IVD Applications
Are you a manufacturer applying to register a medical device or IVD with the Australian Register of Therapeutic Goods (ARTG)? Now you have more options to fulfill the Manufacturer Evidence requirement to support an application.
The Last Quarter of 2024 in MedTech: It Has Been a Busy Year
Medical device manufacturers who want to stay up to date on the year’s global regulatory developments will appreciate our quarterly regulatory insights.
New Australian Procedure for Recalls, Product Alerts and Product Corrections
The medical device regulator in Australia, the Therapeutic Goods Administration (TGA), announced a preview of a new guidance resource for therapeutic goods corrective actions.
MHRA Finalizes Legislation on Post-Market Surveillance Requirements
The UK medical device regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) finalized the Post-Market Surveillance statutory instrument (PMS SI) in December 2024. Medical device manufacturers doing business in the UK will want to familiarize themselves with this new regulatory requirement to remain compliant and maintain market access.
Brazil’s Medical Device Regulator ANVISA Announces Clinical Investigation Database
As the end of the calendar year approaches, Brazil’s National Health Surveillance Agency (ANVISA) has released its database on clinical investigations.
2023 South Korea Regulatory Overview
In this webinar, our Emergo by UL subject matter expert outlines the latest updates on medical device regulatory requirements in South Korea.
MHRA Publishes Revised Roadmap of Future Regulatory Framework for Medical Devices
The UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), published a revised roadmap outlining the intended timelines for delivering a future regulatory framework for medical devices.