FDA
The new article highlights the aspects related to the main principles on which the least burdensome approach is based, and also describes the key points related to the said principles. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
Asia
The new article highlights the main points related to the secondary assembly of medical devices intended to be marketed and used in Australia. In particular, the document addresses the assembly area requirements, storage conditions, and labeling. Table of Contents...
FDA
The new article describes the responsibilities of institutional review boards (IRBs) when assessing clinical studies related to medical devices, as well as the approach to be applied when determining the regulatory status of such studies based on the risks associated...
Malaysia
The article describes in detail the approach to be applied when determining the regulatory nature of borderline products as set forth by the current legislation in Malaysia. The Medical Device Authority (MDA), a body of the Ministry of Health Malaysia responsible for...
FDA
The article provides an overview of key points and principles related to the least burdensome provisions. 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...
EU MDR/IVDR
The article provides additional details regarding the matters related to the notification made in the context of designation and the appropriate publication. Table of Contents The Medical Device Coordination Group (MDCG), an advisory body of the European Commission...
