International Medical Device Regulatory Monitor

EU device regulations should be more in line with the U.S., with randomized controlled trials considered the highest standard to document efficacy and safety, a Belgian federal institution is urging. Includes the full text of Premarket Evaluation of Innovative Medical Devices.

Health ministers of the BRICS countries (Brazil, Russia, India, China and South Africa) are collaborating to address trade barriers and other challenges to healthcare product access in the regions.

As the Global Harmonization Task Force (GHTF) prepares to reorganize, its chairmanship is transitioning from Australia to Japan.

Devicemakers in New Zealand and Australia will be able to submit one patent application for simultaneous review in the two countries beginning in 2013.

Brazil’s National Health Surveillance Agency (Anvisa) and Sweden’s Läkemedelsverket (Medical Products Agency) have signed a cooperation agreement to share information and discuss mutual areas of interest.

While small and medium-size enterprises (SME) in Europe’s device sector reportedly find it the most predictable market for regulatory approval, much more can be done to protect the innovation potential of the more than 7,000 device SMEs in Europe, Eucomed says.

Australia’s Therapeutic Goods Administration’s (TGA) transparency review panel is calling on the agency to take several steps toward greater transparency, including developing an early postmarket risk communication scheme and creating an online tracking system for applications.

Review, application and registration fees for medical devices and medicines in Australia are increasing by 3.4 percent.

The U.S. Food and Drug Administration (FDA) is exempting 30 different types of diagnostic and radiology devices from premarket requirements and has released a guidance outlining the affected products.

Device companies and drugmakers will need to work closely and quickly to ensure novel therapeutic products and their companion in vitro diagnostic (Dx) devices are ready for U.S. Food and Drug Administration (FDA) review at the same time, a draft guidance says.

The U.S. Internal Revenue Service (IRS) should use U.S. Food and Drug Association (FDA) regulatory decisions as guides to ensure combination products don’t get double-taxed under the healthcare reform bill.

Certain software, such as applications for smartphones used in mobile health (mHealth) technologies in conjunction with medical devices, should not be regulated, according to the mHealth Regulatory Coalition.

The FDA’s Microbiology Devices advisory panel has unanimously recommended the U.S. Food and Drug Administration (FDA) consider down-classifying certain diagnostic tests for tuberculosis (TB) infections.

The medical device industry will have to wait a bit longer for regulations on the unique device identifier (UDI) database and electronic medical device reports (eMDRs).

Device spending and prices are not contributing to the rising cost of healthcare.