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 1日

ANVISA Moving Brazil GMP Inspection Fee from Annual to Biennial Schedule

Brazil’s National Agency for Sanitary Surveillance (ANVISA) will purportedly begin charging inspection fees for Certificates of Good Manufacturing Practice and Quality Control (Brazil GMP) every two years rather than on an annual basis.
阅读更多
2011年 4月 5日

US Hospital Groups Wary of Medical Device Tax’s Impact

Hospital industry trade groups including the American Hospital Association, the Federation of American Hospitals and the Catholic Health Association of the United States are warning that their members
阅读更多
2011年 4月 8日

US Government Shutdown Would Hamper FDA Clearance and Approval Process

A potential shutdown of the US government due to Republican lawmakers’ stance on budget negotiations would significantly reduce the Food and Drug Administration’s ability to conduct inspections of foo
阅读更多
2011年 4月 11日

EHTI Research Takes Aim at “Innovation Paradox” in EU Medtech Procurement Policy

New research by the European Health Technology Institute for Socio-Economic Research (EHTI) puts forth five recommendations to address the impact of more centralized medical technology procurement pol
阅读更多
2011年 4月 12日

FDA Weighs Classifying EHRs as Medical Devices

The US Food and Drug Administration (FDA) is considering whether to regulate electronic health records (EHRs) as medical devices as it develops new rules targeting software, according to Center for Devices and Radiological Health (CDRH) director Dr. Jeffrey Shuren.
阅读更多
2011年 4月 18日

BVMed Annual Report: Healthy Returns, but Stronger Regulatory Support for Innovation Needed

In its latest annual report , German medical device industry trade group BVMed (Bundesverband Medezintechnologie)...
阅读更多
2011年 4月 18日

GAO Finds FDA’s Review and Safety Processes Inadequate

In April 13 testimony before the US Senate’s Special Committee on Aging, Government Accountability Office...
阅读更多
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...
阅读更多
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...
阅读更多
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
阅读更多

Pages