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The International Medical Device Regulators Forum laid out its agenda for the next two years, with plans to finalize a regulatory framework for software as a medical device and guidance on sharing of adverse event data in 2015. Read More
A scientific panel reviewing the use of mercury-containing dental amalgams and alternative materials says evidence of a serious safety risk in either group is weak and the choice of product should be based on patient characteristics. Read More
As EU notified bodies begin conducting the unannounced audits required by the European Commission, devicemakers need to make sure they have at least two employees who are prepared to handle an audit. Read More
As notified bodies in the EU conduct the first wave of unannounced quality audits of devicemakers, they are building profiles of the companies to determine when and how often they are inspected in the future. Read More
India’s medtech industry could reach $50 billion by 2025 if comprehensive regulatory and reimbursement infrastructures are put in place, a new market research report says. Read More
Devicemakers are urging the Therapeutic Goods Administration to amend its low-value turnover exemption scheme for entries in the Australian Register of Therapeutic Goods to allow more small businesses to take advantage of it. Read More
Makers of low and moderate risk devices can now use the U.S. Food and Drug Administration’s de novo pathway to gain approval without first filing for 510(k) clearance — a route the agency hopes devicemakers will take. Read More
The Therapeutic Goods Administration plans to obtain its own evidence on the quality of certificates and reports issued by select EU notified bodies, after a medical journal report cast doubt on the thoroughness of the reviews they were performing. Read More
The Brazilian government is proposing major reforms to its public-private Product Development Partnership program, doubling the allowable length of PDP agreements from five to 10 years and establishing a committee to approve the projects. Read More
Devicemakers could see their wait time to begin clinical trials cut by more than a third under a proposed regulation calling for protocols to be reviewed in their entirety, rather than in stages, as is the current practice. Read More
Sponsors of Class II and Class III medical devices in China may bypass the need for clinical trials if they can show that the product is equivalent to a product listed in the country, new guidance says. Read More