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.

2011年 4月 20日

FDA Grants Six-month Extension for Transition from Steris

The US Food and Drug Administration has allowed a six-month extension to health care facilities...
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2011年 4月 21日

Regulatory Updates affecting the EU Market

The European Commission has issued a new version of the "Manual on Borderline and Classification...
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2011年 4月 21日

New Guidance from FDA on 30-Day Notices

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has issued
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2011年 4月 25日

New Guidelines for Medical Technology Issued in the UK

The National Institute for Health and Clinical Excellence (NICE), an organization providing health care-related guidances and standards in the UK, has
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2011年 4月 25日

FDA’s Office of Combination Products Revises Guidance on RFD Submissions

The US Food and Drug Administration’s Office of Combination Products (OCP) has updated its guidance on Request for Designation (RFD) documents submitted by manufacturers or their sponsors in order to determine how to classify their devices. The revised guidance spells out more clearly what information the OCP requires within an RFD in order to more promptly determine whether a product should be regulated as a drug, device, biological product or combination product.
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2011年 4月 27日

ANVISA Accepting Public Comments for New Medical Device Grouping Criteria

Medical device manufacturers interested in submitting comments to Brazilian regulator ANVISA regarding proposed new grouping criteria have until May 8 to do so.
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2011年 5月 2日

Updated Guidance from FDA on Reusable Medical Device Labeling Out for Comment

The Food and Drug Administration (FDA) has issued draft guidance on labeling of reusable
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2011年 5月 6日

Licensing Changes in Place at Health Canada

Health Canada has announced several changes to its licensing processes over the past several weeks, some of which have been
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2011年 5月 6日

Final Guidance from FDA on Dispensing Devices Sold with OTC Drugs

The US Food and Drug Administration has published final guidance targeting over-the-counter drug products packaged with syringes, droppers and other dispensing devices.
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2011年 5月 9日

GHTF Issues Final Guidance on Medical Device Regulatory Model

The Global Harmonization Task Force (GHTF) has published final guidance advocating global convergence of medical...
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