New Zealand – Guideline on the Regulation of Therapeutic Products in New Zealand
Pharmacovigilance is defined by the WHO as the science and activities relating to the
detection, assessment, understanding and prevention of adverse events or any medicinerelated...
Australia – Understanding regulatory requirements for in vitro diagnostic (IVD) companion diagnostics (CDx)
The purpose of this guidance is to outline the regulatory framework for in vitro diagnostic (IVD) companion diagnostics (CDx) and for the medicine or...
Australia – How to submit a custom-made medical device / patient-matched medical device notification...
The following guide is designed to assist you with completing and submitting a:
• Custom-Made Medical Device (CMMD) notification; and
• Patient-Matched Medical Device (PMMD) transition...
Australia – Refinements to the Personalised Medical Device Framework
The public consultation indicated the importance of the TGA’s role as the regulator of
medical devices, affirming that in the majority of cases medical devices...
China- Medical Device Administrative Control System (MDACS)
During the life-cycle of a medical device, changes may take place from time to
time. To safeguard public health, the information in the Medical Device...
Europe – MDCG 2019-13 Guidance on sampling of MDR Class IIa / Class...
Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish the requirements for sampling of...
Europe – Interface between the Regulations on clinical trials of medicinal products, medical devices...
In the EU, there are legal requirements for the individual authorisation processes of clinical trials of medicinal products, clinical investigations of medical devices and...
UK – Medical Devices Regulatory Reform – Roadmap to implementation – Update
A roadmap outlining the intended timelines for delivering a future regulatory framework for medical devices and an intended policy on international recognition...
Australia – Medical devices vigilance program pilot
The TGA is commencing a new Medical Devices Vigilance Program (MDVP). The MDVP will begin as a 12-month pilot. The pilot is designed to...
Europe – Commission launches a public consultation and a call for evidence for EU...
The Commission has launched a public consultation and a call for evidence on the EU’s legislation on medical devices and in vitro diagnostic medical devices, as...
