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 new article highlights the aspects related to the classification rules applicable to specific categories of healthcare products.
The article provides a general overview of the classification framework for medical devices.
The new article highlights the key points related to the specific categories of changes and describes the way the regulatory status of such changes should be determined based on the nature of such changes, the impact they are expected to have on the safety and...
The new article describes in detail the way a risk-based approach should be applied with respect to clinical trials involving human subjects, paying special attention to the initial risk assessment to be carried out by the party responsible for a clinical...