Canada
The new article highlights certain specific matters to be addressed in all the applications for a medical device license in order to ensure the authority is provided with all the information needed to assess the safety and effectiveness of the product subject to review.
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 new article describes in detail the applicable types and classes of recalls and also explains the difference between recalls and non-recall actions from a regulatory standpoint.
EU
The article highlights the key points associated with the regulatory status of certain products placed on the EU market and also describes in detail the approach to be applied with respect to qualification.
HSA
The new article outlines specific aspects associated with the registration of medical devices intended to be marketed and used in Singapore, emphasizing the most essential matters to be considered to ensure compliance with the requirements set forth under the existing legal framework.
Saudi Arabia
The article highlights the critical points associated with the regulatory framework for surgical sutures intended to be marketed and used in Saudi Arabia.
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