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The U.S. FDA has taken a giant step toward encouraging the use of unique device identifiers, with the launch of a public website making UDI data available to the public. Read More
While China’s year-old medical device regulations require clinical trials for Class II and Class III devices, there are some exceptions and regulators are in the process of finalizing guidance to help companies take advantage of them, an expert says Read More
The China Food and Drug Administration has issued 90 industry standards — 14 mandatory and 76 recommended — covering implants for surgery, medical electrical equipment, in vitro diagnostic reagents and dentistry. Read More
The International Medical Device Regulators Forum has issued a proposed document explaining how to use quality management systems to regulate software as medical devices. Read More
Devicemakers doing business in the Czech Republic face a steeper regulatory burden than before, thanks to regulations that took effect April 1. The new law requires devicemakers, importers and distributors to archive product safety documentation for five years and subject products to regular validation testing. Read More
Manufacturers planning to participate in the Medical Device Single Audit Program should first study up on Australian and Brazilian regulations, an official at the first company to go through a MDSAP audit tells GMP. Read More
The FDA has banned imports of Doro’s Evacu B wheeled stretchers for infants, after a Nov. 10-13, 2014, inspection found serious GMP violations related to the device Read More
Australia’s Therapeutic Goods Administration has updated the procedures for determining when fees can be reduced for audits and conformity assessments of medical devices. Read More
CDRH has reviewed 69 percent of PMA products approved before 2010 — exceeding its 2014 target — as it works to implement a goal of speeding new technologies to patients without compromising safety. Read More
Devicemakers are doing a better job meeting FDA standards for 510(k) submissions, CDRH Director Jeffrey Shuren told an industry group Thursday. Read More