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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 says. Read More
The China Food and Drug Administration is proposing to require medical devicemakers to file clinical trial record forms, as the agency strengthens its oversight of devices. Read More
Health Canada is proposing 52 changes to its list of recognized standards for medical devices, including the addition of 26 new standards and updates to nine others. Read More
GMP violations including failure to submit a premarket approval application for its denture liner and failure to register the device in 2015 prompted an FDA warning letter to Better Health Systems. Read More
The FDA issued a warning letter to Thermedx, a Solon, Ohio-based manufacturer of gynecological and urological fluid management systems, for failing to notify the agency of device upgrades and other GMP violations. Read More
The U.S. FDA plans to withdraw 30 draft guidance documents affecting medical devices issued between 1988 and 2011, because they are obsolete or no longer considered necessary. Read More
Devicemakers looking to market their products for use in children based on adult clinical trials should limit their use of that data to situations in which the course of the disease or condition and the device’s effects are “sufficiently similar” in both populations, the U.S. FDA says. Read More
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