China Issues Fresh Guidelines Urging Device Makers to Utilize AER Systems

The China Food and Drug Administration plans to step up its tracking of medical device adverse events in hospitals, and is asking high-risk and Class III device makers to refer to a 2011 guideline on electronic monitoring to facilitate submission of incident reports.

Borderline Product Ruling Cements Challenges for Devicemakers

A recent decision by the EU Court of Justice on borderline products affirms a practice by member states that can pose challenges for devicemakers, says Erik Vollebregt of Axon Lawyers in the Netherlands. The court ruled in case C-109/12 that individual member states may classify the same product differently, whether as a medicinal product requiring clinical data or as a medical device.

Single-Audit Pilot Rolls Out in January, Will Be Limited to CMDCAS Registrars

The International Medical Device Regulators Forum will launch its medical device single audit program (MDSAP) pilot in January in the U.S., Canada, Australia and Brazil.  The program will run for three years in pilot phase and has the potential to overhaul inspection and enforcement activities in the participating countries.  For devicemakers, the benefit is that a single inspection could eventually serve all IMDRF nations, taking the place of the routine audits currently conducted separately. Preapproval for-cause and compliance follow-up audit responsibilities would be retained by member nations in most cases.

AdvaMed urges Parliamentary Committee to consider its views on Medical Devices Bill

The Advanced Medical Technology Association (AdvaMed), an association of international medical device manufacturers, has urged the Parliamentary Standing Committee on Health and Family Welfare to consider its recommendations for the Drugs & Cosmetic (Amendment) Bill 2013 (known as the medical devices bill) so that the benefits of the bill can result in faster and safer solutions for Indian patients and more investments for the country.

FDA Unique Device Identification System

The Food and Drug Administration (FDA) is issuing a final rule to establish a system to adequately identify devices through distribution and use.