Update on Notified Bodies designation under MDR / IVDR
The implementation of the new European MDR (2017/745), now in place since May 2021 and IVDR (2017/746) less than a year away, has proven to be a very challenging task...
MR Compatibility and Materials Science
Magnetic Resonance Imaging (MRI) is a well-established diagnostic technology. Since its introduction in the early 1980s, it has been widely used and extensively developed. It has many of the capabilities...
Australia’s TGA releases updated Essential Principles Checklist
In Australia, for any given device, irrespective of risk classification, manufacturers must demonstrate compliance with the Therapeutic Goods Administration (TGA) essential principles. The essential principles define the requirements for the...
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...
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...
