China’s National Medical Products Administration is gearing up to implement a unique device identification system and it has created a pilot program that will focus on high-risk implantable devices first.…

The FDA cited six devicemakers for problems with complaint procedures, change controls and quality oversight, among other deficiencies. Source: The GMP Letter

The FDA issued a warning letter to Polymer Technology Systems — doing business as PTS Diagnostics — arising from an inspection earlier this year of its facility in Indianapolis. Source:…

The FDA is making new recommendations to manufacturers of duodenoscopes to transition to new designs that will eliminate the need for reprocessing. Source: The GMP Letter

Russia’s Ministry of Health has rolled out new requirements for internal quality control and monitoring of the safety of devices in medical facilities. Source: The GMP Letter

Houston-based medical devicemaker Talon received a lengthy FDA warning letter for design process and quality control issues following an inspection of the firm’s manufacturing facility. Source: The GMP Letter

The International Medical Device Regulators Forum (IMDRF) has issued a new draft document on harmonizing terminology and codes for reporting adverse events for medical devices and in vitro diagnostics. Source:…

Devicemakers have raised concerns about the European Commission’s proposed specifications for reprocessing single-use devices. Source: The GMP Letter