Swiss Medtech Guidance Document for Legacy Devices Compliance
Swiss Medtech released a guidance document tailored for economic operators in Switzerland. It delineates the necessary steps for…
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TGA UDI System: What Manufacturers Must Know for Compliance
The Therapeutic Goods Administration (TGA) Unique Device Identification (UDI) system has been in development for several years with several…
New MDCG Guidance on Investigator’s Brochure for Medical Device Trials
The Medical Device Coordination Group (MDCG) is active this month, releasing a new guidance document. This latest guidance focuses…
QSR vs. QMSR: FDA’s New Quality System Requirements
On February 2, 2024, US FDA published the final rule harmonizing its quality system requirements to…
Update on Swissmedic FSCA Report and PRRC Change
Changes to Swissmedic FSCA Report V2.3 Swissmedic has recently updated the Foreign Serious Incident Report (FSCA) template to version 2.3.
Common Mistakes When Undergoing MDR Notified Body Agreements
The revised transitional provisions of the MDR allow for the following devices to be placed on…
Australia Prostheses List and Implications for Medical Device Manufacturers
Following several years of industry complaints regarding the process for obtaining private health insurance reimbursement authorization for devices and…
EU MDR Compliance Deadline for Legacy Devices is Approaching
By 26 May 2024, manufacturers must have an MDR compliant Quality Management System in place and have lodged an application…
FDA eSTAR Program Simplifying Medical Device Regulatory Submissions
Since its initial pilot and coming into force for non-exempt 510(k) submissions in October 2023, the FDA eSTAR Program…
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