
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...