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Negotiations on the fourth iteration of the Medical Device User Fee Act will swing into full gear July 13, with an FDA public meeting to assess the current MDUFA and ways to improve it. Read More
Devicemakers should develop a design flexible enough to allow for use outside the U.S. with modest revisions, the FDA's former chief UDI architect says. Read More
Devicemakers should expect to see the European Council’s final version of the proposed medical device and in vitro medical device regulations next month, an EU industry official says. Read More
Australia’s Therapeutic Goods Administration is proposing changes to its low-value turnover exemption scheme that could help some devicemakers save money while reducing red tape and making the process more user-friendly and transparent. Read More
Health Canada exceeded its review targets for device submissions during the 2015 first quarter, reviewing new Class II devices in an average of nine days, six days quicker than the 15-day goal, and completing Class IV device reviews in an average of 70 days versus a 75-day goal. 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 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