Review of Recent Regulatory Amendments in Australia: International Harmonization and Reliance
Australia’s regulator, the Therapeutic Goods Administration (TGA), has implemented several significant regulatory reforms for medical devices and IVDs so far this year, with more on the horizon.
Introduction to Medical Device Labeling, Standards and Symbols
Discover more about medical device labeling, global challenges and how symbols and electronic labeling help provide key information and simplify compliance.
EU Publishes Guidance on In Vitro Diagnostic Devices
The various MEDDEV guidance associated with the Directives has been tremendously helpful before and even after the IVDR’s release.
Dutch Regulators Find Ongoing Compliance Issues for Post-market Surveillance
The Dutch authorities have published the report of their activities related to post-market surveillance (PMS).
Third Quarter of 2024: Global Medical Device Regulatory Harmonization Continues with an Emphasis on UDI
This update features regulatory harmonization and a number of global developments revolving around Unique Device Identifiers (UDI).
Determining External Critical Design Attributes when Conducting Threshold Analyses for Combination Product
Emergo by UL Human Factors Specialists share tips on how to determine external critical design
attributes when conducting threshold analyses.
Alexandria Carlson
Yvonne Limpens
Strategic Approaches to Global Regulatory Success: Effective Global Regulatory Strategy
This feature focuses on what to consider in developing an effective global regulatory strategy. Learning objective 2 during our sponsored RAPS 2024 session titled Navigating and Managing the Global Regulatory Landscape: Strategic Approaches for Success, revolves around a plan for the medical device global regulatory approach.
Proposed Medical Device Legislative Changes in China
The regulator in China, the National Medical Products Administration (NMPA), has proposed regulatory reforms to medical devices.