Get the latest global medical device regulatory news from our experts.
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
IVD Devices: From Performance Evaluation Studies to Clinical Performance Studies, What has Changed?
For the marketing of in vitro diagnostic (IVD) medical devices manufacturers need to demonstrate that their products perform as claimed, which typically requires performance data obtained from appropriate studies or from available state-of-the-art literat
Placing Medical Devices on the Swiss Market After the EU MDR Date of Application
Under the European Union's Medical Devices Regulation (MDR), Switzerland is currently considered a third country for medical devices. Find out what that means for manufacturers and importers, and how to safeguard obtain the proper clearance to place Europe
Consultation Open for Swiss Ordinance Governing IVD Products
The Swiss federal office of public health (FOPH) announced the opening of a public consultation on the draft in vitro diagnostics ordinance (IvDO) and amendments to the ordinance on clinical trials for medical devices (ClinO-MD).