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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...
Pile of Documents

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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Recent Posts

China Medical Device Regulations – Major Updates

Apr 8, 2021

European Medical Devices Regulation (EU MDR) Implementation date is just around the corner

Mar 30, 2021

Technical File Differences Between Medical Devices and IVD Medical Devices

Mar 26, 2021

Taiwan FDA Unique Device Identifier (UDI) Draft Regulation

Mar 8, 2021

Hitting the Accelerator

Mar 4, 2021

Prescription Medicine Pathways

Feb 25, 2021

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