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 9月 12日

FDA Details New Medical Device Registration and Listing Requirements

The US Food and Drug Administration has published a list of frequently asked questions regarding
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2012年 9月 7日

ANVISA, Brazil’s medical device market regulator, has ended a months-long strike

ANVISA, Brazil’s medical device market regulator, has ended a months-long strike that had complicated foreign manufacturers’ importation and commercialization efforts in the country.
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2012年 9月 5日

New European Norm Harmonized Standards Go Into Effect

There are big changes in the world of European Norm harmonized standards!
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2012年 8月 29日

New Whitepaper Urges Better Reimbursement Process for CIED Telemonitoring in Europe

European Union regulators must develop a robust country-level reimbursement framework for remote monitoring of cardiac implantable electronic devices (CIED), according to a new whitepaper by PriceWaterhouseCoopers, the European Heart Rhythm Association (EHRA) and Eucomed.
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2012年 8月 23日

Important changes to US FDA establishment registration requirements

There are important changes coming soon from the US FDA that may affect your company...
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2012年 8月 22日

Big changes in the world of EU harmonized standards

We note that there is considerable change in the world of harmonized standards.
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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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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 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 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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