medical device

Winding Road

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

As the long-awaited deadline for the implementation of the European Medical Devices Regulations (EU MDR) finally draws near, it is now more important than ever to understand the applicable deadlines...
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Technical File Differences Between Medical Devices and IVD Medical Devices

With the Medical Device Regulations (MDR) coming into force from 26 May 2021 and the upcoming In Vitro Diagnostics Regulations (IVDR) from 26 May 2022, the regulatory requirements are finally...

Taiwan FDA Unique Device Identifier (UDI) Draft Regulation

Taiwan has recently published a draft regulation of their Unique Device Identifier (UDI) Requirements for Medical Device Labels on 5 November 2020. This regulation will be applicable to all imported...

Transition Plan and Regulatory Changes for Software as Medical Devices

In our November 2020 blog post, we communicated the changes regarding the implementation dates and the criteria for Software as a Medical Device regulations as amended in the Therapeutic Goods...

New Access to China Medtech market via Greater Bay Area Initiative

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...
3D Printing of Hand

Transition plan from Custom device to Patient-matched

In our Blog of June 2020, we communicated on the delays relating to the implementation dates of the December 2019 amendment of the Therapeutic Goods (Medical Devices) Regulations 2002. The...
Clinical Evidence

Clinical Evidence Insights for Medical Devices in China

Registration of medical devices in China requires a clinical evaluation report (CER) regardless of the device classification. For many, preparing a CER that meets China’s requirements is a daunting challenge...
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The Medical Devices Regulation (EU) 2017/745 and In Vitro Diagnostic Regulation (EU) 2017/746 include use, maintenance and management of a European databank on medical devices (EUDAMED). The database consists of...
Crisis management

Six uncomfortable regulatory truths in a pandemic

These are truly extraordinary times. With supply chains breaking down and demand outstripping supply for critical products such as ventilators, masks and test kits, both regulators and industry are having...
Clearing fog

TGA acceptance of international device reviews – clearing the fog

A recent discussion on the RAPS bulletin board (link here for members) revealed confusion as to what international evidence can be used to support Australian regulatory approvals for medical devices....


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