"Recast" is now "revision" - bigger changes on the way for the European Directives?

Jacqueline Minor, Director of Consumer Affairs, European Commission DG SANCO has indicated at recent RAPS and Eucomed meetings that the anticipated upgrade of the devices directives will likely convert the current "Directives" to a Regulation - providing opportunity for more substantial changes and more prescriptive powers for the European Commission and more detailed input from the European Parliament.

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Medical Device Recalls in China – are you prepared?

Perhaps you are still eyeing the $8 billion medical device market in China or maybe you have already set up your shop there. Either case, you should make sure you are aware of this newly published guideline on medical device recalls, the Provision on Medical Devices Recalls (interim) 医疗器械召回管理办法（试行）

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What's Hot and What's Not in Mobile Apps Regulation

A recent AusBiotech session on mobile medical apps raised some hot issues on regulation of these "medical devices"

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Proposed Chinese Clinical Trial Exemption for some Class II Medical Devices

Some class II device manufacturers may soon be exempt from providing Chinese clinical trial data for regulatory approval in China - meaning a substantial reduction in regulatory burden for many Class II devices manufacturers.

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Australian Regulation of Medical Devices - is there a better way?

The Australian Senate Community Affairs Committee has established an inquiry into the regulatory standards for approval of medical devices. The terms of reference include the role of the TGA and the processes of regulation in Australia (both pre- and post-market) and there is a particular focus on orthopaedic implants.

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