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Swissmedic Guidance on Incident Reporting: Overview
The article highlights the key points related to the regulatory requirements in the sphere of incident reporting in the context of healthcare products allowed for marketing and use in Switzerland.
The article highlights the key points related to the regulatory requirements in the sphere of incident reporting in the context of healthcare products allowed for marketing and use in Switzerland.
The new article describes in detail certain specific aspects associated with registrations necessary to make submissions associated with healthcare products.
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.