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
US FDA Revokes Emergency Use Authorizations (EUA) for Some Personal Protective Equipment (PPE)
US regulators have revoked emergency use authorizations for some non-NIOSH-approved personal protective equipment (PPE) as the country's COVID-19 public health emergency situation evolves. Learn more at Emergo by UL.
US FDA Aims to Improve Cybersecurity Related to Servicing and Maintenance of Medical Devices
FDA seeks feedback from stakeholders on four key cybersecurity issues associated with servicing of medical devices. Learn more about US FDA medical device cybersecurity regulations at Emergo by UL.
Chinese Regulatory Bodies Provide Updates on Revised Medical Device Regulations
China's national medical products administration (NMPA) and center for medical device evaluation (CMDE) published announcements and supporting documents relating to State Council Order No. 739, which revised the country's medical device regulations
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