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 11月 1日

PMA Summary Review Database Now Available from CDRH

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has launched a new searc
阅读更多
2011年 11月 1日

New DCGI director for India

Dr. V. G. Somani has been named Drug Controller General of India (DCGI) as of October 31, 2011.
阅读更多
2011年 11月 14日

New FDA Guidance on IDEs for Early Feasibility Studies

The US Food and Drug Administration is proposing a new policy for Investigational Device Exemption (IDE) applications for
阅读更多
2011年 11月 11日

Device Classification Guidance Issued by GHTF

As it transforms into a new organization , the Global Harmonization Task Force (GHTF) continues to issue guidances likely to influence major medical device regulators worldwide.
阅读更多
2011年 11月 11日

Australia: License Cancellation for Non-Payment of Fees, ARTG Database

In September, the TGA released a response to the to the Australian Government Health Technology...
阅读更多
2011年 11月 10日

Comment Period Extended for FDA’s Guidance on 510(k) Device Modifications

The US Food and Drug Administration has extended its comment period to November 28, 2011 for guidance the agency issued
阅读更多
2011年 11月 7日

Drug and Medical Device Modernization Law Nearing Adoption in France

Two versions of a draft law amending regulations of pharmaceutical and medical technology products in France have been adopted by the French National Assembly and Senate.
阅读更多
2011年 11月 7日

GHTF Unveils Successor Organization

The Global Harmonization Task Force (GHTF) will evolve into the International Medical Device Regulators' Forum (IMDRF) , with the new organization’s inaugural meeting set to take place in Singapore in early 2012.
阅读更多
2011年 11月 3日

Push for Med-tech Innovation Policy Underway in Germany

The German government has formed a committee of industry and regulatory experts charged with developing a national innovation policy for medical technology.
阅读更多
2011年 11月 2日

FDA Seeks Feedback on Device Labeling Requirements

The US Food and Drug Administration (FDA) has requested public comment from health care providers until January 3, 2012 on its proposed
阅读更多

Pages