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.

2012年 5月 22日

FDA Report Slams EU Medical Device Approval Process

A new report issued by the US Food and Drug Administration argues that the European Union's regulatory system fails to ensure safety of high-risk medical devices it approves .
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2012年 6月 5日

CBO: US Device Excise Tax Repeal would Cost $30 Billion over Ten Years

Ahead of highly anticipated US Congressional votes to repeal the planned 2.3% medical device excise tax, an analysis by the Congressional Budget Office anticipates $29.1 billion in lost federal revenues through 2022 if the repeal goes into effect.
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2012年 6月 7日

CDRH Process for Resolving Internal Medical Device Review Disagreements Needs Improving

Processes in place to resolve scientific disagreements among FDA medical device reviewers need stronger definitions and clearer lines of responsibility, according to the US Health and Human Service
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2012年 6月 12日

HSA Releases Additional Details on New Singapore Registration Routes

The Health Sciences Authority (HSA), Singapore's medical device regulator, has published draft guidance on new expedited and immediate evaluation routes for Class B low-risk devices.
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2012年 6月 12日

Electronic Recycling Regulation in British Columbia Now Applies to Medical Devices

Electronic equipment recycling regulations in place in British Columbia since 2004 now cover some medical...
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2012年 6月 19日

Brazilian Customs Strike Could Affect Medical Device Shipments

A national strike by customs workers in Brazil stands to significantly delay imports of medical devices into the country.
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2012年 6月 21日

Swedish Regulators Publish Guidance on Software as a Medical Device

Sweden's medical device market regulator, the Medical Products Agency (MPA), has issued expanded guidance on how the European Commission plans to address software used as medical devices . The Swedish guidelines follow a revision to Medical Device Directive 2007/47/EC announced in January 2012, MEDDEV 2.1/6, which addressed stand-alone healthcare software falling into the EU's medical device regulatory framework.
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2012年 6月 22日

FDA Guidance would Reclassify Implanted Blood Access Devices to Class II (Special Controls)

New draft guidance from the US Food and Drug Administration (FDA) would allow reclassification of implanted blood access devices for hemodialysis procedures to Class II (special controls).
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2012年 6月 25日

Japanese Government Open to Medical Device Regulation Revisions

The Japanese government is reportedly considering changes to its Pharmaceutical Affairs Law (PAL) that would include separate rules and regulations for medical devices.
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2012年 6月 27日

EU PIP Scandal - Will PMA System Be The Result?

As we recently reported, the effects of the recent PIP scandal continue to ripple across the European Union.
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