International Medical Device Regulatory Monitor

Revising the role and transparency of notified bodies in the EU’s medical device approval process could be the centerpiece of the European Commission’s September recast of the Medical Device Directive (MDD).

Countries in the Association of Southeast Asian Nations (ASEAN) would have to establish postmarketing surveillance alert systems to report and evaluate device-related adverse events and make the information available to other member states under a draft medical device directive released for comment this summer.

Makers of hip, knee and shoulder joint implants have two years from July 1, 2012, to apply for their products to be transitioned from Class IIb to Class III devices in Australia, according to the Therapeutic Goods Administration (TGA).

China’s State Food and Drug Administration (SFDA) has wrapped up a public consultation on the reclassification of 745 in vitro diagnostic (IVD) reagents as part of an effort to develop a more sophisticated device classification system.

Makers of home use medical test kits must be able to demonstrate that they can be properly used by people who lack specialized training, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) says in new guidance for notified bodies.

Makers of Class IV devices that choose not to use a summary technical documentation (STED)-based license or amendment application must provide details on manufacturing and quality controls, a device-specific quality plan and process validation studies, according to a Health Canada final guidance.

European medical device makers will be required to use a new labeling standard that reduces the need for multiple languages on a single label and reduces potential confusion and delays for selecting the appropriate language when using a device.

Color-coding or labeling tubes to reduce risks associated with enteral tube misconnections will no longer be considered enough of a precaution under a new U.S. Food and Drug Administration (FDA) draft guidance.

The European Parliament and Council are wrapping up their review of a proposed regulation that would ban several types of mercury-containing medical devices because of their potential toxicities.

The U.S. Office of Management and Budget has approved the U.S. Food and Drug Administration’s (FDA) long-awaited proposed rule on a unique device identifier (UDI), clearing it for release by the agency.