International Medical Device Regulatory Monitor

A proposed Global Harmonization Task Force (GHTF) document aims to create a uniform system for premarket adverse event (AE) reporting as part of the approval process.

The European Council’s proposed reforms to the judicial system for the EU-wide single patent system will exclude third-party countries, according to a “non-paper” on the topic.

The European Council is calling on member states and the European Commission (EC) to provide clearer classification criteria for medical devices, and to improve the risk-based classification system for new products, particularly in vitro diagnostics.

The European Commission’s (EC) Employment, Social Policy, Health and Consumer Affairs Council is suggesting changes to notified body (NB) oversight, such as designating them only for the assessment of devices or technologies that correspond to their proven expertise.

UK industry stakeholders are raising concerns over the General Medical Council’s (GMC) proposed guidance on prescribing off-label or unlicensed medical products.

Canadian devicemakers must provide, when requested, a summary of their validation procedures for confirming that their reusable devices will be sterile when reprocessed, a final Health Canada guidance says. Includes the full text of Health Canada Reprocessing and Sterilizing Guidance for Devices.

Health Canada is not meeting its obligations for regulating medical devices despite recent increases in overall program funding and capacity, the auditor general of Canada says.

Despite some drawbacks, Latin America is a prime location for medical device sector growth, an industry representative says.

Medical device companies in New Zealand (NZ) and Australia will see reduced barriers to market thanks to an agreement between the two nations to implement a joint regulatory agency within the next five years.

Industry stakeholders can weigh in on the Medical Technology Association of Australia’s (MTAA) Code of Practice on interactions between devicemakers and physicians as the organization begins its triennial review of the code.

In light of increasing competition from developing nations, AdvaMed released a “competitiveness agenda” to maintain the U.S.’ role as a leader in the device industry.

The U.S. Court of Appeals for the Federal Circuit has increased the threshold patent-challengers must use to allege inequitable conduct in litigation.

The U.S. Food and Drug Administration (FDA) should launch a program to routinely and systematically assess device recall information, and use this program to identify strategies for mitigating health risks presented by defective or unsafe devices, the U.S. Government Accountability Office (GAO) says.

The U.S. patent system will undergo its first major overhaul in years as the U.S. House of Representatives passed its version of the America Invents Act June 23 by a 304–117 vote.

The U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) plans to cut back on domestic facility inspections in fiscal 2012 in an effort to ramp up its visits to foreign sites, an official says.

Outlining a “roadmap for discussion,” the U.S. Food and Drug Administration (FDA) released a draft of its nanotechnology guidance, to help industry better determine whether an FDA-regulated product uses nanotechnology.

The second major study released in as many months is showing that total calendar days for the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) reviews have increased substantially.