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...
The article highlights the aspects related to the rights and responsibilities of Institutional Review Boards in the context of informed consent. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere...
The article provides a general overview of the regulatory requirements for in vitro diagnostic medical devices intended to be marketed and used in the United Kingdom. Table of Contents The Medicines and Healthcare products Regulatory Agency (MHRA), the UK...
This article details the process of modifying existing registration entries for medical devices permitted for marketing and use in Mexico. Table of Contents Mexico’s medical device regulatory authority, COFEPRIS, has released guidance on changes to the sanitary...
The new article highlights the aspects related to placing certain medical devices on the market with the respective CE certificates expired or expiring soon. Table of Contents The Medicines and Healthcare Products Regulatory Agency (MHRA),the UK regulating...
The article provides an overview of the existing regulatory framework for submissions related to healthcare products. Table of Contents The Health Services Authority (HSA), Singapore’s regulating authority in the sphere of healthcare products, has published a guidance...
Canada
