Health Canada Draft Guidance on Significant Changes: Types of Changes
The new article describes specific types of changes to medical devices in detail and outlines the critical points related to the regulatory status thereof.
The new article describes specific types of changes to medical devices in detail and outlines the critical points related to the regulatory status thereof.
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The article provides an overview of the draft guidance document describing the procedures related to certain certificates related to medical devices. Table of Contents The Medical Device Authority (MDA), a Malaysian regulating authority in the sphere of healthcare...
The article provides an overview of the new classification rules to be applied. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a set of guidance documents dedicated...
The new article describes in detail the approach to be applied by the parties responsible for medical devices when notifying the authority about the products subject to reclassification they are going to supply. Table of Contents The Therapeutic Goods Administration...