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 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.
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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.
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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?
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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
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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.
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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...
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2009年 12月 21日

Update to EU medical device vigilance guidance

The European MEDDEV 2.12.1 entitled "Guidelines on a Medical Devices Vigilance System" has been revised.
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2010年 1月 5日

Clinical Data Requirements & Guidance on Vigilance Revised

As you are well aware, Directive 2007/47/EC goes into effect March 21, 2010. This Directive will affect all medical devices (except IVDs) marketed in Europe.
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2010年 1月 20日

New Version of European MEDDEV 2.7.1 on Clinical Evaluation Now Available

A revision of European guidance MEDDEV 2.7.1, entitled "Clinical Evaluation: A Guide for Manufacturers and Notified Bodies" was issued in December 2009.
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2010年 1月 27日

PMDA Issues List of Pre-Market Certificates Issued by RCBs in Japan

The PMDA has just recently released a spreadsheet enumerating the pre-market certificates issued by each of the 12 Registered Certification Bodies (RCBs) sanctioned under the Pharmaceutical Affairs La
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