International Medical Device Regulatory Monitor

The EU is one step closer to mandating premarket authorization for Class IIb and Class III medical devices, following the European Parliament’s adoption of proposals aimed at beefing up device regulation in the wake of the PIP silicone gel breast implant scandal.

China is expected to reclassify some in vitro diagnostic (IVD) and medical imaging devices to lower-risk categories as part of a reform of its classification system that began in 2009, industry experts say.

Sweden’s Medical Products Agency (MPA) is asking a European Commission working group to address certain issues before adopting a draft guideline on when a stand-alone software program is regulated as a medical device.

The South Korean Food and Drug Administration (KFDA) has revised its Medical Device Act to shorten the registration process and reduce the number of requirements for Class I and II medical devices.

Singapore’s Health Sciences Authority (HSA) has revised its guidance on registration of Class B devices to incorporate new expedited and immediate registration routes for products already authorized in major international markets.

China’s State Food and Drug Administration (SFDA) has launched a trial program to increase unannounced inspections of medical device manufacturers and ensure companies are following good manufacturing practices (GMP).

The U.S. Food and Drug Administration (FDA) expects to pilot a mobile version of the MedWatch reporting form on hand-held devices by the end of this year, one of several new software tools the agency is developing to improve postmarket monitoring of adverse events.

PHILADELPHIA – As Taiwan and South Korea apply health technology assessment (HTA) to sift out the costs versus benefits of new drugs and medical devices, other Asian countries, such as China, are looking at ways to adopt such cost-cutting programs, a pair of recent industry surveys suggests.

As Canadian healthcare facilities begin to insist on credentialing of medical device sales reps, industry stakeholders are offering advice on vendor credentialing policies to avoid issues that have plagued U.S. organizations.

Legislation reauthorizing medical device and prescription drug user fees for another five years is headed to President Barack Obama’s desk to be signed into law, following a 92–4 Senate vote approving the bill on June 26.

Compared with the EU and other international markets, medical devicemakers face greater regulatory uncertainty and a more burdensome approval process for their products in the U.S., an industry survey concludes.

After 12 years, the Global Diagnostic Imaging, Healthcare IT & Radiation Therapy Trade Association (DITTA) has officially incorporated in the U.S., a move that will allow it to better influence discussions on global medical imaging concerns, an association official says.

The U.S. Food and Drug Administration (FDA) needs to insist on more quality data in 510(k) premarket notification and premarket approval (PMA) applications and provide real-time postmarket surveillance data that is transparent, Rita Redberg, chief editor of the Archives of Internal Medicine and professor of medicine at the University of California, San Francisco, told the 2012 PharmedOut Conference in Washington, D.C.