Tuesday 20 February 2018

Guidance Documents

Brazilian Regulators Go On Strike – ANVISA

August 3, 2012 | 1 comment

In mid-July Brazilian government officials, including those at the regulatory agency ANVISA, walked-out on strike, leaving the agency critically under-staffed. As […]

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FDA Unveils Proposed Device Identification System, New Database

July 3, 2012 | 2 comments

The FDA has released a proposed rule that requires most medical devices distributed in the United States carry a unique […]

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EU Looks to Tighten Medical Device Safety With Implant Registry

April 30, 2012 | No comments

In the wake of high-level scandals in the EU, including the Poly Implant Prothese (PIP) breast implant snafu and the metal-on-metal hip […]

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FDA Strengthens International Collaboration to Ensure Quality, Safety of Imported products

April 26, 2012 | No comments

The FDA’s Global Engagement Report shed light on the volume of imported food, medical devices, and pharmaceuticals and outlines the measures taken […]

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Report: Internal FDA Reports Slams European Regulation of Medical Devices as Ineffective

April 24, 2012 | 2 comments

The FDA has criticized Europe’s review process for medical devices in an unreleased internal report, claiming the failure of some […]

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New FDA Guidance on Considerations Used in Device Approval, De Novo Decisions

March 28, 2012 | No comments

The U.S. Food and Drug Administration today published a first-of-a-kind guidance for medical device manufacturers, describing how the benefits and risks of […]

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