Worldwide Medical Device Regulatory Updates
As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That is why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you.
US medical device and IVD regulators plan stronger oversight of laboratory developed tests (LDTs) as these products have become more widely used and riskier to patients and users.
The Malaysian Medical Device Authority (MDA) has published new guidance on its conformity assessment process in order to provide more information to authorized representatives, manufacturers and conformity assessment bodies, or CABs.
Recent data from the US Food and Drug Administration shows that additional information requests (AI) for 510(k) medical device premarket notification applications remain high, but also that the frequency of AI requests has fallen slightly since 2010.
Once medical device manufacturers receive US FDA clearance or approval, they must then establish effective distribution partnerships to realize their business goals. In this Emergo podcast, common issues around how to develop viable US distribution strategies and qualify distribution partners are discussed.
The Malaysian Medical Device Authority (MDA) has published draft guidance on new medical device labeling rules as well as mandatory problem reporting based primarily on European Union labeling requirements.
The US Food and Drug Administration increased its number of quality system inspections at foreign medical device manufacturing sites in 2014, expanding on its years-long effort to monitor FDA Good Manufacturing Practice compliance at sites based outside the US.
Taiwanese medical device market regulators are launching their new “two-step” review program on November 10, 2015, after which administrative and technical device reviews will no longer be conducted in parallel.
The Australian Department of Health has started consultations on how to improve the country’s private health insurance system that may affect how implantable medical devices are reimbursed once any potential reforms are implemented.
New draft guidance released by the US Food and Drug Administration explains what supporting documents some medical device manufacturers should include in premarket applications to prove electromagnetic compatibility (EMC) of their products.
The International Medical Device Regulators Forum (IMDRF), the group of major medical device market regulators previously known as the Global Harmonization Task Force or GHTF, has announced plans to focus efforts on improving post-market surveillance and premarket review processes for devices through 2020.