HSA
The new article describes in detail the key aspects related to the advertising activities in the context of medical devices intended to be marketed in Singapore.
TMMDA
The article highlights the critical points related to the legal framework for medical device testing, control, and calibration.
Australia
The article describes the recall procedures to ensure the continued safety of medical devices and other therapeutic products allowed for marketing and use in Australia.
Australia
The new article describes in detail the first three steps of a recall process, which include obtaining information and distribution status, conducting a risk analysis, and deciding on the type, class, and level of recall.
Australia
The new article provides additional details regarding the subsequent steps of the recall process, including the development of an action strategy, drafting a communication strategy to be followed when conducting a recall, and also the matters related to interactions with the authority, such as the noes associated with the submission of the relevant notification and an assessment to be conducted by the TGA
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