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.

2009年 6月 11日

European Commission issues interpretation of Directive 2007/47/EC

The European Commission has issued an interpretative document (dated 5 June 2009) of Directive 2007/47/EC (which amends the Medical Devices Directive MDD 93/42/EEC and the Active Implantable Medical Devices Directive AIMDD 90/385/EEC).
2009年 6月 11日

European Commission issues important guidance document on 2007/47/EC

The EU has just released an important guidance document that should be read by every company selling medical devices in Europe.
2009年 6月 25日

Redesigned US FDA website an improvement

The US FDA recently launched a new website, with a new look and organization.
2009年 8月 12日

MHRA publishes updated guidance document for clinicals conducted in UK

In July, the MHRA issued an updated guidance document on clinical investigations to be carried out in the UK.
2009年 8月 13日

Health Canada to require STED format for Class 3/4 medical device submissions

Health Canada just put out an official notice that they are going to require the STED format for most Class 3 and Class 4 medical device license submissions by July 2010.
2009年 9月 23日

FDA Hosts Public Hearing to Address the Internet and Social Media and how they Relate to Product Regulation

The FDA is holding a public hearing on November 12 and 13, 2009 from 8am to 5pm each day to discuss the increasing challenges that social media and the internet have presented to product regulation. The hearing will be at the National Transportation Safety Board Conference Center in Washington, D.C. In addition to the public meeting, the FDA will also accept comments (electronic and hard copy) until February 28, 2010.
2009年 10月 5日

Guidance on sampling requirements for Class IIa and IIb devices set forth in EU Directive 2007/47/EC

Directive 2007/47/EC becomes effective March 21, 2010 and will require Notified Bodies to review a sample of Technical Files for Class IIa and Class IIb devices. The most frequent question from companies with numerous devices has been: What is an appropriate sample?
2009年 10月 8日

Faster medical device approval times in Japan may be in store

As part of Japan’s Five Year Action Plan, Japan has set goals for specific in-house improvements to ease the process of obtaining clearance from the Pharmaceuticals and Medical Devices Agency (PMDA) a
2009年 10月 9日

House Increases FDA Funding for Medical Devices

The US House of Representatives has passed a bill that will increase funding for the FDA’s Center for Devices and Radiological Health (CDRH), to US$315M in fiscal year 2010.
2009年 11月 9日

Suggested Change to QSP 9.1-5, Advisory Notice, Recalls, and Vigilance Reporting

The European Commission website has been redesigned and an important web page listing Vigilance Contact...