
FDA Guidance on Laboratory Developed Tests: Overview
The article describes in brief the key points related to the regulatory framework for laboratory-developed tests.
The article describes in brief the key points related to the regulatory framework for laboratory-developed tests.
The new article highlights the key points related to the change notification procedure applicable to medical devices allowed for marketing and use in Malaysia.
The article describes in detail certain aspects to be considered when applying grouping criteria for medical devices intended to be marketed and used in Malaysia.
The article provides a general overview of grouping requirements applicable in Malaysia.
The article provides a general overview of grouping requirements applicable in Malaysia.