Get the latest global medical device regulatory news from our experts.
US FDA Roundup: Final De Novo Rule, GUDID for Class I Medical Devices, Reclassification of Surgical Staples
US regulators have issued final rules for de novo novel device classification requests and up-classification of surgical staplers, as well as updated GUDID submission requirements for some class I devices. Learn more at Emergo by UL.
US FDA Rolls Out List of Registered Medical Devices Featuring Artificial Intelligence and Machine Learning
FDA regulators have published a searchable list of medical devices incorporating artificial intelligence and machine learning (AI/ML) to promote transparency. Learn more about US FDA regulations at Emergo by UL.
Australia TGA to Accept CE Mark Conformity Assessments for Some High-Risk Medical Devices, IVDs
The therapeutic goods administration (TGA) will accept conformity assessments from European notified bodies for some Class III medical devices, active implantable devices and Class 4 IVDs submitted for registration in Australia. Learn more at Emergo by UL
Singapore HSA Finalizes Unique Device Identification (UDI) Requirements for Medical Devices
Singapore's health sciences authority (HSA) has issued final guidance on unique device identification (UDI) rules for medical devices and IVDs, with a phased implementation timeline for compliance. Learn more at Emergo by UL.
Chinese Regulators Revise Drug-Device Combination Product Registration Requirements
Chinese regulators have updated marketing application requirements for makers of combination products featuring pharmaceutical and medical device components. Learn more about NMPA regulations for combination products, medical devices and IVDs.
Proposed US FDA Program Targets Medical Device Supply Chain Shortages
A new program proposed by the US Food and Drug Administration would bolster domestic supply chains for medical devices during public health emergencies, but would also entail additional compliance work for manufacturers.
South Korea MFDS Plans Several Medical Device Regulatory Updates for 2022
The Ministry of Food and Drug Safety (MFDS), South Korea’s medical device market regulator, plans to roll out several amendments to the country’s Medical Devices Act over the course of 2022, and has also expanded its list of devices eligible for electronic
New Guidelines Published on Integrating UDI Into Quality Management Systems Under MDR, IVDR in Europe
The European Medical Device Coordination Group (MDCG) has published new recommendations for medical device manufacturers on integrating Unique Device Identification (UDI) data into their quality management systems