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.

Apr ,11 2011

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
Mar ,30 2011

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
Mar ,30 2011

Affirmations of Compliance Codes (AofC Codes)

According to informal discussions with the FDA, proper use of
Mar ,30 2011

Expediting Customs Clearance with AofC Codes

The FDA recently issued a Letter to Industry with recommendations
Mar ,31 2011

US Meddev Industry Gaining Congressional Sympathy

In a sign of the US medical device industry’s increasing
Mar ,31 2011

MITA Weighs in on Excise Tax Issues

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

EU Considers Applying Transparency Directive to Medical Devices

The European Commission may extend its Transparency Directive covering pricing
Apr ,01 2011

ANVISA Moving Brazil GMP Inspection Fee from Annual to Biennial Schedule

Brazil’s National Agency for Sanitary Surveillance (ANVISA) will purportedly begin
Apr ,05 2011

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
Apr ,08 2011

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