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The article provides an overview of the draft guidance document describing the procedures related to certain certificates related to medical devices.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...
FDA
The new article addresses the aspects related to different grounds for delays occurring before and during an inspection. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
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...
FDA
The new article addresses the aspects related to supplemental reports medical device manufacturers should submit and also provides an overview of the summary reporting instructions. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
Saudi Arabia
The article provides an overview of the regulatory requirements for clinical trials of medical devices. Table of Contents The Saudi Food and Drug Administration (SFDA), a country’s regulating authority in the sphere of healthcare products, has published...
FDA
The article provides an overview of the factors resulting in delaying or refusing an inspection. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft guidance...
