Saudi Arabia
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...
Malaysia
The article provides an overview of the draft guidance document describing the procedures related to certain certificates related to medical devices.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...
Australia and Oceania
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...
Australia and Oceania
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...
Australia and Oceania
The new article provides an overview of the recent changes to the classification rules for active implantable medical devices. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has...
