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New Access to China Medtech market via Greater Bay Area Initiative

By Jenny Lin | 15 February 2021
In June 2019, China accepted a new initiative proposed by the Hong Kong Special Administration Region (SAR) to allow the sale of Hong Kong-registered medical devices and drugs to Hong...
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DOC’s will need to be submitted for new Class I IVD ARTG registrations

By Luis Jimenez | 26 November 2020
Similarly, to TGA’s recent notification on 1 October 2020, the TGA has issued a notice of upcoming changes for Class IVD registrations via an email to stakeholders on 17 November...
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Software as Medical Devices (SaMD) Growing Regulatory Trends and Opportunities for Innovators

By Luis Jimenez | 27 September 2018
With SaMD attracting larger players and devices like the Apple Watch, FDA and regulators globally, are developing frameworks for regulating these more efficiently. On Sept 11th, 2018 Apple obtained FDA...

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MR Compatibility and Materials Science

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