Asia
The article describes in detail the approach to be applied with respect to clinical evidence the parties responsible for medical devices are expected to provide when applying for marketing approval. Table of Contents The Health Sciences Authority (HSA), Singapore’s...
Canada
The article highlights the aspects related to the regulatory status of such categories as “medical device group”, “medical device group family” and “medical device system”. Table of Contents Health Canada, the Canadian regulating authority in the sphere of healthcare...
FDA
The article highlights the aspects related to existing submission formats and key considerations associated thereto in the context of the Voluntary Improvement Program. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority...
Australia
The article highlights the aspects related to the regulatory framework for telecommunication products, radiation-emitting medical devices as well as the software used to power healthcare products. Table of Contents The Therapeutic Goods Administration (TGA), an...
Asia
The article addresses the aspects related to the labeling requirements in vitro diagnostic devices should comply with, as well as the approach to be applied with respect to risk analysis in order to ensure the proper health protection and safety of patients. Table of...
FDA
The new article addresses the aspects related to the voluntary improvement program introduced by the US regulating authority. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare...
