SFDA Guidance on Medical Devices Samples Collection: Overview
The article provides an overview of the regulatory framework for sample collection.
The article provides an overview of the regulatory framework for sample collection.
The highlights the aspects to be taken into consideration in order to ensure the real-world data used to support regulatory submissions is relevant and reliable.
The new article highlights specific points related to medical device registration in Singapore under the existing legal framework.
The article highlights the aspects related to the definition of shortage and the steps the authority takes to mitigate the associated risks.
The new article describes in detail the approach to be followed when applying for registration and marketing approval for Class A and B medical devices.