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 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 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 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 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 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 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 27日

ANVISA Announces Continuity Measures for Medical Device Importers During Strike

Update 08/27/2012: The Brazilian Supreme Court has recently ordered ANVISA to operate at 70% capacity despite the agency's ongoing strike in order to address medical supply issues affecting healthcare providers in the country. According to Emergo Group's Brasilia office as well as Brazilian shipping service provider Fiorde International , various hospitals in Brazil are reporting shortages of blood reagents, medications and other hospital materials that are reportedly stalled at the border and cannot clear Brazilian customs. Barring a breakthrough in ongoing negotiations , observers expect effects of the ANVISA strike to last through November.
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2012年 7月 31日

WEEE2 Will Impose Recovery and Recycling Requirements on Medical Devices

A revised Waste Electrical and Electronic Equipment Directive (WEEE2, 2012/19/EU) will expand recovery and recycling targets for electronic medical devices in the European Union.
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2012年 8月 2日

Regulators in Singapore Lower Some Medical Device Registration Fees

The Health Sciences Authority (HSA), the agency regulating the medical device market in Singapore , has lowered registration fees for its Special Authorization Routes (SAR) to expand public access to low-risk devices.
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2012年 8月 6日

US FDA Opens Small-Business Medical Device User Fee Discounts to More Foreign Manufacturers

The US Food and Drug Administration has opened small business qualification to foreign companies--including those that have not submitted US income tax returns--and also eliminated establishment registration fee discounts for small businesses as part of the agency’s updated Medical Device User Fees for 2013.
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