Anaheim, California-based Anacom MedTek hadn’t established procedures for finished device acceptance, for acceptance of incoming product or for CAPA activities, an FDA inspection found. Read More

Multiple repeat deficiencies related to medical device reporting, CAPAs, validation procedures and acceptance activities were uncovered during an FDA inspection of General Medical Company’s Jacksonville, Florida manufacturing facility. Read More

Failure to establish procedures for design control and to document control procedures and acceptance activity procedures were just a few of the 483 observations cited for device specification developer and repackager Web 2U Com during an inspection of its Fort Lauderdale, Florida plant. Read More

Janssen flagged problems it faced during reviews of combination products in a comment to the Office of New Drugs. Read More

The FDA will hold a March 5 public workshop on evaluation practices for virtual and augmented reality in medicine at the agency’s White Oak Campus in Silver Spring, Maryland. Read More

Time is running out for devicemakers to meet the May 26 deadline to renew or extend their device certificates under the new EU Medical Devices Regulation, MedTech Europe stressed in its latest status report. Read More

Taiwan’s legislature passed the Medical Device Management Law, which separates the country’s regulation of medical devices from pharmaceutical products for the first time. Read More

China’s National Medical Products Administration (NMPA) updated its clinical trial regulations for medical devices last month, designating eight device categories that require clinical trials. It also added new exemptions from clinical trial requirements, allowed conditional approval with limited clinical data and published guidelines on the use of real-world data (RWD). Read More

The EU’s Medical Device Coordination Group released new guidance on cybersecurity requirements for devicemakers under the new Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). Read More