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 7月 23日

ANVISA Strike to Delay Medical Device Reviews in Brazil

Employees of Brazil’s medical device regulator ANVISA have gone on strike for an indeterminate length of time, resulting in delays for device manufacturers awaiting regulatory approval to sell their products in the country.
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2012年 7月 12日

SFDA releases China Provisions on Medical Devices Recalls

China’s State Food and Drug Administration (SFDA) strengthened its efforts to protect human health and safety via regulation of medical device recalls.
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2012年 7月 10日

US MDUFA Changes Signed into Law (Finally)

( Update: The following blog entry was revised on July 23, 2012 to reflect the most recent fee schedule in place at the FDA.) The Medical Device User Fee Amendments of 2012 (MDUFA III) providing increased funding for the US Food and Drug Administration have been signed into law as part of the FDA Safety and Innovation Act (FDASIA) by President Obama following months of intense negotiations between medical device industry and regulatory representatives.
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2012年 7月 9日

Final Guidance on Class III, IV Device Licensing from Health Canada

Health Canada has released final guidance on supporting evidence requirements for Class III and Class IVC medical device license applications. The guidance specifies scientific information requirements for manufacturers submitting Class III and Class IV device license applications, excluding makers of Class III and IV IVD products. (Health Canada plans separate updated guidance on higher-risk IVDs in the future.)
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2012年 7月 3日

Unique Device Identifier Rule Proposed by US FDA

The US Food and Drug Administration has published a proposed rule that would require medical devices marketed in the US to be
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2012年 6月 27日

Regulatory Updates for Australia as a result of the RegTech Forum

On June 22 we attended “Sponsor Information and Training Day” in Canberra organized by the “Regulatory and Technical Consultative Forum for medical devices” (RegTech Forum).
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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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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 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 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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