European regulators issue recommendations for integrating UDI into medical device, IVD QMS processes

The Health Sciences Authority (HSA) is inviting stakeholders to comment on its guidelines for the risk classification of software as a medical device (SaMD) and the criteria for when clinical decision support software (CDSS) applications qualify as medical devices.

Remote FDA inspections of drug facilities affecting life sciences companies' learning management and training needs

The Saudi Food and Drug Authority issued new requirements relating to measuring and tracking the temperature and humidity of storage facilities and transportation vehicles.

FDA's final guidance on Unique Device Identifier (UDI) requirements for medical device and SaMD manufacturers

Part 2 of our series on challenges and recommendations regarding estimating use errors for medical devices

Latest FDA EUA revocations target non-NIOSH-approved respirators

FDA discussion paper raises awareness of cybersecurity risks and vulnerabilities tied to servicing of medical devices

The regulatory body is no longer accepting provisional authorization (PA) applications for tests. It also provided details on the process for authorization antigen rapid test (ART) self-test kits.

EU MDCG Q&A on Eudamed registraton for actors not covered by MDR Article 31 or IVDR Article 28

The document addresses maintenance activities performed on products that have the potential to impact their regulatory status.

Special considerations for conducting clinical performance studies for companion diagnostics under the European IVDD and IVDR

LMS features and functionality that life sciences companies and manufacturers should look out for in third-party vendor offerings

The Australian regulator is ending a measure intended to lessen the financial impact of elective surgery cancellations on medical device companies.

The National Medical Products Administration (NMPA) and Center for Medical Device Evaluation (CMDE) have issued announcements and supporting documents relating to the implementation of State Council Order No. 739.