Medsafe
The new article describes in detail the application process to be followed by the interested parties when applying for authorisations in the context of clinical trials.
Medsafe
The new article explains the requirements pertaining to notifications for clinical trials, as well as the Good Clinical Practice requirements.
The new article clarifies the regulatory requirements related to record-keeping and reporting in the context of clinical trials.
FDA
The article highlights the key points related to the submissions associated with novel medical devices intended to be marketed and used in the US.
FDA
The new article provides additional details pertaining to the submission template to be used by the parties interested in applying for marketing permission for medical devices utilizing innovative technologies.
