MD Regulatory transition under Brexit
With the UK having exited the EU in February 2020 (Brexit), manufacturers of medical devices and IVDs need to ensure they have plans in place to comply with the UK...
DOC’s will need to be submitted for new Class I IVD ARTG registrations
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...
TGA guidance for SaMD Regulatory “Carve Out”
Following a public consultation on the Regulation of software, including Software as a Medical Device (SaMD) in early 2019, the TGA introduced several regulatory changes, including: new classification rules for...
Upcoming update to the Taiwan FDA Medical Devices Act
Taiwan has one of the most enviable healthcare systems in the world - it boasts the number one ranking among 93 countries two years in a row from mid-2018 and...
TGA deploys Post Market Review Compliance Dashboard
Under the Therapeutic Goods Act 1989, it is mandatory for sponsors and manufacturers to report adverse events that have, or could have, led to death, serious illness or injury to...
TGA Issues guidance for sponsors with lapsing Conformity Assessment Certificates
On 13 October 2020, the TGA specified that it will take a broader view in the case that companies suffer a lapse on renewing their Conformity Assessment Documents in response...
TGA will require DOC’s to be submitted for Class I ARTG registrations
Australia’s, Therapeutic Goods Administration (TGA) issued a notice on 1 October 2020, in addition to an email to stakeholders prior, specifying new policies for the inclusion of non-sterile, non-measuring Class...
What you need to know about disinfectants in Australia
In May 2020, we looked at hand sanitisers and TGA’s exemption on certain formations in response to the COVID-19 emergency. As we are seeing an increasing number of corporations receiving...
