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… Learn more
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… Learn more
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.
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… Learn more
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…… Learn more
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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 Japan, China to Australia and more. Discover what it takes to succeed in APAC markets. Can’t make it to California in March? This is so good we are running it twice – also on February 1-2, 2018 in Zurich, Switzerland
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Risk Assessments, Design Controls, Biocompatibility , Clinical Evaluation Reports we can provide comprehensive technical support to ensure compliant product development. We can prepare full regulatory submissions for Medical Devices (including medical software) IVDs and combination products. We have the depth of technical expertise and international experience you need to support your expanding business.
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