International Medical Device Regulatory Monitor
May 2012 | Vol. 20 No. 5 | Full Issue in PDF Format
As fallout from the defective PIP breast implant imbroglio continues, a European Parliament health committee is calling for tough new regulatory controls, including the creation of a premarket authorization system for certain categories of medical devices — an idea that brought immediate kickback from industry.
A Dutch proposal to tighten device vigilance in the EU would intensify inspections of devicemakers that operate internationally and organize surveillance around the complete life cycle of specific product lines.
The European Commission is preparing guidance to assist notified bodies during inspections of facilities where CE-marked medical devices are made.
Cross-border sharing of devicemaker audit results should be easier, thanks to a standardized nonconformity grading system developed by the Global Harmonization Task Force’s (GHTF) Study Group 3.
Concerns over who will take over as the Drug Controller General of India (DCGI) in mid-May are leading some industry observers to worry about another backlog in medical device import licenses and registrations.
Singapore’s Health Sciences Authority (HSA) is easing the registration process and reducing fees for about 70 percent of medical devices, in a bow to industry concerns about the cost of registering devices there.
China is expected to begin amending its current medical device rules this year, as part of its 12th five-year plan to update its drug and device regulations, according to a panel of China experts at the Food and Drug Law Institute’s annual conference in Washington, D.C.
Bulgaria is creating an electronic register of medical devices to promote transparency and increase its control over device procurement, according to PMR, a British-American company providing information to international businesses interested in Central and Eastern Europe.
The U.S. Food and Drug Administration (FDA) and other agencies must provide expertise, training and tools to developing nations to improve their device and drug monitoring practices and prevent dangerous healthcare products from entering the U.S., according to an April 4 Institute of Medicine (IOM) report.
Over the next several years, the U.S. Food and Drug Administration (FDA) will engage more with its international counterparts through systems that will allow it to share real-time information and resources in a more comprehensive way than is currently possible.
AdvaMed will add full-time staff on the ground in China, Brazil and India over the next three years under a new strategic plan unveiled April 19.
A panel of European medtech experts is calling for simplified, more efficient reimbursement policies and purchasing procedures to reduce barriers to speed access to novel devices developed by small and medium-sized enterprises (SMEs).
User fees for medical device license and renewal rose 2 percent in Canada, effective April 1.
Sponsors of some 510(k)s for in vitro diagnostics and radiological devices could hear back from the U.S. Food and Drug Administration (FDA) more quickly under a pilot program aimed at speeding high-quality applications.
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