MDR: Common Issues for Medical Device Manufacturers (Presented in Portuguese)
This presentation, presented in Portuguese, reviews the resources of the European Commission.
Australian TGA Releases Important Annual Charge Deadlines
Australia’s Therapeutic Goods Administration (TGA) has announced deadlines and key dates for its latest annual charges.
Mexico’s Ministry of Health Updated Requirements for Medical Device Registration Submissions
Mexico’s Ministry of Health has updated its requirements for medical device registration submissions.
Mexico’s Ministry of Health Updates Requirements for Medical Device Registration Renewals and Modification Submissions
Mexico’s Ministry of Health has updated its requirements for medical device registration renewals and modification submissions.
Mexico’s Ministry of Health Updated Requirements for Medical Device Registration Grouping
Mexico’s Ministry of Health has updated its requirements for medical device registration grouping.
Mexico’s Ministry of Health Updated Regulation for Software as a Medical Device (Appendix X)
Mexico’s Ministry of Health has updated its regulation for software as a medical device (SaMD), known as Appendix X.
Update to European Guidance on Medical Device Significant Changes
Medical device manufacturers should assess any changes to their device design or intended purpose to determine if they are considered significant under newly updated EU regulatory guidance.
Global Impact of (EU) Regulation 2023/607
Based on the glacial progress, delays with regulatory compliance, and paucity of notified bodies, (EU) Regulation 2023/607 was promulgated in mid-March to provide a longer transition timeline for manufacturers with legacy devices in the EU.
US FDA Medical Device Classification
Our white paper explains the FDA’s risk-based classification system for medical devices.
How the IVDR Impacts Intended Purpose and Classification
In this webinar, our Emergo by UL expert outlines the latest updates on how the IVDR impacts intended purpose and classification.