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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 That’s the bottom line in a U.S. Food and Drug Administration draft guidance released June 17.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
Canadian devicemakers are praising their government’s plan to implement an internationally harmonized system of unique device identification, but say it must become “truly global” to avoid additional barriers to trade. Read More
The U.S. Food and Drug Administration’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
As of April, EU member states and the European Commission had conducted five mandatory joint assessments of notified bodies, with one resulting in a negative decision, according to a working document prepared by Commission staff and presented to the Council of the European Union. Read More
For the first time, manufacturers submitting 510(k)s would have to show FDA reviewers that the risks and benefits of a candidate device are acceptable and substantially equivalent to those of the predicate device, according to draft guidance issued last week. Read More