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 1月 23日

US Government to Require Device Manufacturers to Disclose Payments to Doctors

The Obama Administration has announced plans to require medical device and pharmaceutical companies to report payments they make to US doctor and other health care providers for research, consulting and travel.
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2012年 1月 18日

European Med-Tech Trade Groups Join Forces

European medical technology association Eucomed and the European Diagnostic Manufacturers Association (EDMA) are forming a single industry trade federation to more effectively lobby on behalf of their medical device and IVD manufacturing members.
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2012年 1月 13日

Mises à jour réglementaires de l'UE

L’année 2011 touchant à sa fin, nous vous informons de quelques nouvelles de fin d’année en provenance de l'Union européenne.
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2012年 1月 13日

New and Revised MEDDEVs for the European Union

The European Medical Device Expert Group (MDEG) convened on Tuesday January 10, 2012 in Brussels...
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2012年 1月 12日

Chinese Medical Technology Market Primed for 17% Growth According to Citigroup

A new Citigroup Global Markets report on China’s medical device and technology industries expects the...
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2012年 1月 12日

Mexico Updates Lists of Class Ia Devices, Third-Party Reviewers

Mexico’s medical device market regulator COFEPRIS has formally published a new list of medical devices that no longer require registration and those that qualify for new Class Ia status in th
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2012年 1月 10日

GAO Finds FDA Data on Pediatric Devices Lacking

A recent report by the US Government Accountability Office (GAO) finds that the Food and Drug Administration has not consistently taken steps to identify and track medical devices designated for pediatric use .
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2011年 12月 19日

China Allows Clinical Trial Waivers for Some Class II Medical Devices

Update 12/20/2011: According to Emergo Group sources in Beijing, the waiver policy was instituted by the Beijing FDA (BFDA) rather than the SFDA. Furthermore, the policy applies only to domestic medical devices in China, not imports.
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2011年 12月 19日

New FDA Guidance Emphasizes Gender Differences in Clinical Studies

New draft guidance from the US Food and Drug Administration recommends improvements to medical device manufacturers’ clinical study designs in order to better assess safety and effectiveness of their products according to gender.
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2011年 12月 19日

CMC Decision on Labeling, EC Translation & Croatia in the EU

As 2011 winds down, we write you with some final news for the year from the European Union.
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