QMS Developments in South Africa: SAHPRA joins MDSAP and starts to require ISO 13485
The South African Health Products Regulatory Authority (SAHPRA), announced two important Quality Management System developments.
South Korea’s MFDS Revises K-GMP Regulations for Medical Devices and IVDs
South Korea’s Ministry of Food and Drug Safety (MFDS) has revised legislation related to manufacturing and quality control standards, now consolidated as MFDS Notice No. 2025-22, April 7.
South Korea’s Digital Medical Products Act Now Enforced
South Korea’s Ministry of Food and Drug Safety (MFDS) announced that the Digital Medical Products Act entered into force on January 24, 2025. Read more about this important development.
Mexico’s COFEPRIS Publishes the Final Version of the GMP Standard
We discuss final updates to NOM-241-SSA1-2025 on Good Manufacturing Practice (GMP), their relevance, and how they compare to the previous version of the standard.
Australian Unique Device Identification (UDI) Framework Now in Effect
Australia’s medical device regulator, the Therapeutic Goods Administration, has announced that its Unique Device Identification regulatory framework is now in effect.
FDA ESG NextGen Now Open for Test Submissions
The test submission phase of the new Electronic Submission Gateway NextGen system (ESG NextGen) has been opened by the U.S. FDA in preparation for the official launch on April 14, 2025.
District Court Ruling on FDA Final Rule Regarding Laboratory Developed Tests (LDTs)
Medical device manufacturers operating in the United States (U.S.) need to be aware of new rules for obtaining market access for laboratory-developed tests (LDTs).
First Quarter of 2025: Were There Any Global Medical Device Regulatory Themes?
Our regulatory experts cover major regulatory news that has occurred around the world in the first quarter of 2025.
Risk Categorization Per the European AI Act
Our Emergo by UL experts explain the importance of risk categorization in complying with the European Artificial Intelligence Act and Medical Device Regulation (2017/745 MDR) and In-Vitro Diagnostic Regulation (2017/746 IVDR).
U.S. FDA Clinical Data Requirements for Medical Devices
Learn more about when clinical data is required for U.S. Food and Drug Administration (FDA) submissions such as 510(k), De Novo, PMA and HDE.