FDA
The new article describes in detail the aspects of the different types of interactions with the authority within the Q-Submission concept, emphasizing their specific features and use cases
EU
The new article highlights specific aspects of a clinical investigation plan, such as the approach to be followed concerning the deviations or informed consent and how it should be obtained before commencing a study.
Canada
The article highlights the critical points of managing new submissions related to the products intended to be placed on the Canadian market.
DRAP
The new article describes the approach to be applied concerning reporting and record-keeping in the context of clinical investigations associated with medical devices intended to be marketed and used in Pakistan.
Canada
The article highlights the critical points related to the recall procedures applicable to medical devices allowed for marketing and use in Canada.
Canada
The new article clarifies the recall procedure in the context of the roles and responsibilities of the parties involved.
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