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 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
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2011年 3月 30日

JFMDA Pushes for Industry-Specific Regulatory Framework

The Japan Federation of Medical Device Associations (JFMDA) has begun pushing for regulations specifically targeting the medical device industry ahead of plans next year to revise the country’s Pharma
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2011年 3月 30日

Affirmations of Compliance Codes (AofC Codes)

According to informal discussions with the FDA, proper use of AofC codes can reduce the Customs processing time from several days to a matter of minutes.
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2011年 3月 30日

Expediting Customs Clearance with AofC Codes

The FDA recently issued a Letter to Industry with recommendations for using Affirmation of Compliance (AofC) codes to expedite release of goods from US Customs and Border Protection (CBP) for imported medical devices. Use of the AofC codes is voluntary but recommended to avoid Customs delays. According to informal discussions with the FDA, proper use of AofC codes can reduce the Customs processing time from several days to a matter of minutes. We have listed some of the most commonly used AofC codes here .
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2011年 3月 31日

US Meddev Industry Gaining Congressional Sympathy

In a sign of the US medical device industry’s increasing clout among federal legislators, Senators Scott Brown of Massachusetts and Amy Klobuchar of Minnesota have relaunched the Senate Medical Technology Caucus to drum up Congressional attention on issues such as the 2.3% excise tax and possible changes to the FDA’s 510(k) clearance process.
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2011年 3月 31日

MITA Weighs in on Excise Tax Issues

The Medical Imaging & Technology Association (MITA), the trade group representing US medical imaging equipment manufacturers, has
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2011年 3月 31日

EU Considers Applying Transparency Directive to Medical Devices

The European Commission may extend its Transparency Directive covering pricing and reimbursement transparency of medicinal products to medical devices. EU regulators have launched a public consultation in conjunction with a process review of the Transparency Directive (89/105/EEC) intended to revise pharmaceutical pricing rules, which have not been updated since 1989.
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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.
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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
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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
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