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The FDA’s new changes to data elements within its Global Unique Device Identification Database have dealt a setback to manufacturers who were well into the process of assigning UDIs to their products. Read More
Manufacturers of in vitro diagnostics and low-risk medical devices could have an easier time registering their products in Brazil, thanks to a pair of resolutions proposed by Anvisa. Read More
Over the next four years, the U.S. Food and Drug Administration plans to increasingly coordinate its inspections and enforcement activities with its international counterparts. Read More
The U.S. Food and Drug Administration and Customs and Border Protection are accepting applications for an 18-month pilot of a “trusted trader” program. The initiative aims to reduce inspections and oversight of products imported from manufacturers that establish tough internal import control programs of their own. Read More
Health Canada has published its 2014 list recognized medical device standards, adding 15 new standards and 10 new editions of currently recognized standards Read More
The China Food and Drug Administration published 120 new medtech standards covering everything from metal spine implant system components to blood analyzer reagents, total knee and hip implants and endoscopic instruments. Read More
Citing problems faced by stakeholders, Malaysia’s Medical Device Authority has issued a series of policy notices aimed at helping industry comply with the 2012 Medical Device Act. Read More
Medtech companies are under no obligation to correct misleading third-party statements or claims about their products made on social media, websites and online forums — even if the website is owned by the manufacturer. That’s the bottom line in a U.S. Food and Drug Administration draft guidance released June 17. Read More
Devicemakers using Twitter to promote their products need to include both product benefit and risk information in every tweet, despite the 140-character limitation that Twitter imposes on messages, the U.S. Food and Drug Administration says. Read More
Medical device companies in the Philippines are prohibited from providing financial or material gifts to healthcare professionals for the purpose of promoting their products, according to a recent administrative order by the country’s Food and Drug Administration. Read More
The China Food and Drug Administration has ordered 18 devicemakers to stop publishing advertisements that make false claims about the effectiveness of their products — a move some say shows a new willingness to crack down on illegal ads. Read More
New requirements for the clinical evaluation of medical devices in China, part of a regulatory overhaul that took effect June 1, could slow the introduction of innovative technologies there, industry experts say. Read More