MHRA Guidance on Portal Registration: Overview
The article highlights the key points related to the registration process to be completed by interested parties to be able to make submissions via the e-submission system implemented in the UK.
The article highlights the key points related to the registration process to be completed by interested parties to be able to make submissions via the e-submission system implemented in the UK.
The article provides a brief overview of the regulatory approach to be applied with respect to certain tests intended to be used in the context of an emergency.
The new article provides additional clarifications regarding specific aspects associated with recalls, such as appeals to relevant decisions or disposal for medical products.
The new article pays special attention to the classification of recall actions taken in order to ensure the continuous safety of medical devices allowed for marketing and use in the country.
The new article describes in detail how a recall action should be initiated, emphasizing the key points to be taken into consideration by the parties involved.
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