Malaysia
The article describes updated guidance on re-registration and highlights the key aspects to be taken into consideration for the procedure. The Medical Device Authority (MDA), a Malaysian regulatory agency in the sphere of medical devices, has published a second...
FDA
The present article describes in detail the regulatory approach to be applied concerning monkeypox tests intended to be used in the US in the context of the public health emergency. In particular, the article describes the way the FDA will authorize the use of...
Australia and Oceania
The present article provides a brief overview of the regulatory matters related to the clinical evaluation reports to be submitted by the parties responsible for clinical trials. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating...
FDA
The article provides a brief overview of the existing regulatory requirements for computer software assurance in the context of medical devices. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
Asia
The new article highlights the approach to be applied concerning counterfeit medical devices, as well as the way the parties involved should handle complaints related to medical devices they are dealing with. Table of Contents The Health Sciences Authority (HSA),...
FDA
The present article describes in detail the way the least burdensome approach should be applied. In particular, it explains the ideas behind the concept of the minimum information necessary. Table of Contents The Food and Drug Administration (FDA or the Agency), the...
