HSA
The article provides a general overview of the regulatory framework for product registration submissions, including the relevant procedures for applying for marketing approval 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
Australia
The article provides a comprehensive overview of the requirements to be followed by a party responsible for a recall when preparing and issuing a sponsor’s customer letter to ensure all the critical safety-related information is appropriately communicated to the addresses.
