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.

2012年 4月 16日

Health Canada Amends Lists of Medical Device Standards

Health Canada has announced changes to its list of recognized list of medical device
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2012年 4月 16日

CDSCO Expanding to Enforce New Clinical Trial Rules in India

Indian regulators are adding staff and resources to the Central Drugs Standard Control Organization (CDSCO) in order to enforce more stringent clinical trial guidelines for medical devices and pharmaceuticals.
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2012年 4月 9日

FDA Lists Final Guidance on 513(g) Requests for Information

The US Food and Drug Administration has published final guidance on its process for accepting and responding to 513(g) Requests for Information from medical device manufacturers and sponsors.
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2012年 4月 2日

Singaporean, Malaysian Health Regulators Team Up

The Health Sciences Authority (HSA) of Singapore and the Malaysian Ministry of Health have signed on to a memorandum of understanding in which both agencies will collaborate on regulatory science, enforcement efforts, post market vigilance and quality system issues impacting their respective markets.
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2012年 4月 2日

GAO: FDA Medical Device Review Timeframes Increasing

A new report from the US Government Accountability Office (GAO) provides yet more data showing...
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2012年 3月 29日

ANVISA Gets Strict on Breast Implant Sales in Brazil

Brazilian medical device market regulatory ANVISA has announced tighter controls over sales of breast implants in the country following revelations of defective implants manufactured by French firm
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2012年 3月 27日

US FDA Further Explains its Pilot Program for ISO 13485 Audits

Following last week's announcement that it would implement a pilot program in June waiving FDA GMP quality system inspections for manufacturers choosing to submit recent ISO 13485:2003 audit reports, the US Food and Drug Administration has published additional explanations of how its new program will work.
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2012年 3月 23日

New Health Canada Fees Set for April 1, 2012

Canadian medical device regulator Health Canada plans to increase its fees to manufacturers starting April 1, Emergo Group’s Canada office has learned. For Class II medical device license application reviews, fees will increase from $350 to $357. For Class III medical device license application reviews, HC plans the following increases:
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2012年 3月 19日

Guidance Released for FDA ISO 13485 Pilot Program

As part of a professed effort to align its regulatory practices more closely with those of Global Harmonization Task Force (GHTF) members, the US Food and Drug Administration is set to implement a
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2012年 3月 15日

Neue MEDDEV Leitlinien

Der Anfang des Jahres 2012 bringt wesentliche Neuigkeiten in die Welt der Europäischen Leitlinien (MEDDEVs). Die europäische Expertengruppe für Medizinprodukte (MDEG) hat vier überarbeitete MEDDEVs freigegeben, während drei neue MEDDEV Dokumente sowie ein Leitfaden für eigenständige Softwaresysteme auf der Website der EU Kommission veröffentlicht wurden. Diese Leitfäden beschreiben übereinstimmende Positionen der EU über eine Vielzahl von Themen, die aber nicht rechtsverbindlich sind.
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