International Medical Device Regulatory Monitor

A proposal before the Canadian Parliament to more than triple device user fees could make the Canadian market less attractive to devicemakers.

The Global Harmonization Task Force (GHTF) for the first time suggests requirements for in vitro diagnostic (IVD) devices in a draft guidance on device labeling and instructions for use.

Devicemakers doing business in the EU may continue to have trouble collecting past-due bills from public hospitals, despite efforts to clamp down on government debt.

Mandatory use of Eudamed, the EU’s device databank, is expected to streamline the registration process for makers of in vitro diagnostic (IVD) devices and serve as a first step in making the system more efficient for all devicemakers.

Calling it a first for the U.S. Food and Drug Administration (FDA), Jeffrey Shuren says the agency is exercising its authority across an entire class of devices — infusion pumps — because of “rampant problems” with the technology.

Reusing single-use devices puts patients at increased risk for injury or infection, the European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) says in an opinion adopted last month.

To address cyberthreats to implantable devices, the U.S. Food and Drug Administration (FDA) has been working with the International Electrotechnical Commission and the International Organization for Standardization to develop a new standard, IEC/ISO 80001, that is expected to be finalized and published by the end of the year.

Health Canada is considering updating its Therapeutic Products Directorate’s list of recognized standards for medical devices to reflect the most recent international standards. Includes the full text of Canada’s Proposed Changes To Device Standards.

Volcanic eruptions, reactor shutdowns and a push for low-enriched uranium (LEU) have combined to make South Africa a leading source for a widely used diagnostic isotope.

The U.S. Food and Drug Administration (FDA) is looking to global harmonization to help its devices center deal with a staffing shortage that’s increasing device review times, delaying guidances and limiting access to regulatory officials.

Devicemakers wanting to market their products in Saudi Arabia should begin applying for marketing authorization (MA) beginning Sept. 1.

The Regulatory Affairs Professional Society (RAPS) is partnering with a Chinese university to develop education materials focusing on device regulation.

Devicemakers on both sides of the Atlantic are making a joint commitment to ethical interactions with healthcare professionals (HCPs).

The Global Harmonization Task Force (GHTF) is looking for ways to open a top leadership position to a broader range of its members. Includes the full text of “GHTF Roles and Responsibilities.”