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Archives for February 2018

Are you up to date with the rapidly changing reimbursement environment?

February 20, 2018 by Sarah Griffin

Are you up to date with the rapidly changing reimbursement environment?

There is likely to be a lot of activity in the Private Health Sector in Australia in 2018, particularly in medical devices. Following on from the highly publicised five-year Prostheses agreement between the Commonwealth Department of Health and the Medical Technology Association of Australia, implementation of the agreement must now take place. The agreement included […]

Filed Under: Blog Tagged With: Reimbursement

Using China’s Innovative Device Pathway; CFDA’s Yongheng Chang to address Asia Pacific Device Summit

February 13, 2018 by Arthur Brandwood

Using China’s Innovative Device Pathway; CFDA’s Yongheng Chang to address Asia Pacific Device Summit

We are delighted to confirm that the forthcoming Asia Pacific Device Summit will feature a presentation by Yongheng Chang of China Food and Drug Administration. Mr Chang will speak on China’s Policies to support Medical Device Innovation including navigating the Innovative Device Pathway for CFDA approval, He will also provide an up to the minute […]

Filed Under: Blog

How much clinical data for established devices?

February 12, 2018 by Arthur Brandwood

How much clinical data for established devices?

The new European MDR and IVDR require that all devices are re-qualified – no grandfathering here. So how much clinical data is enough for established devices? European guidance is in the works. It’s time to speak to your Notified Body.

Filed Under: Blog Tagged With: clinical, Europe, IVDR, MDR

TGA introduces priority review pathway

February 2, 2018 by Grant Bennett

TGA introduces priority review pathway

As we introduce a new year, we’ve hit the ground running with new guidance documents published by the Australian regulatory (Therapeutic Goods Administration) in early January. The guidance outlines the requirements for the new Priority review designations For Medical devices (including IVDs). The TGA had discussed the availability of this process as a result of […]

Filed Under: Blog Tagged With: TGA

I’ve a great idea, but now what?

February 2, 2018 by Grant Bennett

I’ve a great idea, but now what?

After attending the Medtech Monday event held in Irvine this week, it became very apparent that the thought of managing the regulatory or quality requirements of your product was a scary one for the novice. This had me thinking of key learnings that I’ve found valuable in product development, and thought I’d share a few… […]

Filed Under: Blog

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International Manufacturer Compliance

One System, many sites.  A US headquartered multi-national implant manufacturer had been marketing in Taiwan for more than ten years and had obtained multiple product approvals based on US FDA approvals. Rapid expansion over that period spanned had enlarged operations to more than 20 separate global manufacturing sites controlled by a single quality system.  Taiwan […]

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Asia Pacific Device Summit

Join us on March 19-20, 2018 in Yorba Linda, California for an exceptional event that will bring you face-to-face with local experts from India to … Learn more

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