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.

Dec ,02 2010

EU Regulatory Update - changes and pending revisions to regulatory guidance documents

Dec ,02 2010

Changes to TGA Medical Device Applications & IVD Guidance Documents

There are modifications to TGA medical device applications, TGA's public regulatory consultation, and IVD guidance.
Dec ,02 2010

US FDA 510(k) Regulatory Process Update

Important changes are affecting the US FDA’s 510(k) process; namely
Dec ,02 2010

New OJEC Standards & MEDDEV on Medical Device Classification

On 7 July 2010, the newly issued list of standards
Dec ,02 2010

Australian TGA Updates IVD Regulations

The Therapeutic Goods (Medical Devices) Amendment Regulations 2010 and the
Dec ,02 2010

DG SANCO, NBOG Guidance & Registration Italy Medical Devices

BfArM has a new PDF form for vigilance which fulfils
Dec ,02 2010

Important regulatory changes in Australia

IVDs will now be regulated by the TGA effective 1 July 2010. Though the Therapeutic Goods (Medical Devices) Amendment Regulations 2010 and the Therapeutic Goods Amendment Regulations 2010 were issued on 25 February 2010, the changes will be implemented on ...
Dec ,02 2010

FDA issues report on proposed objectives for CDRH's 510(k) program

A newly released FDA report has been made available for public comment until October 4, 2010.
Dec ,02 2010

Proposed Changes to Regulatory Approval Process in Mexico

On August 17, 2010, Mexico's President Felipe Calderon announced changes that will affect registration of medical devices in Mexico.
Dec ,02 2010

Updates to medical device classification in Japan

As you may know, medical devices in Japan are classified as follows:

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