Feb 2, 2023
FDA
The new article provides an overview of the revised guidance document and outlines the key points associated thereto. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
Read More
Jun 9, 2022
Australia and Oceania
The article provides an overview of the current regulatory framework for the re-registration of medical devices in Malaysia and describes in detail the most important aspects to be considered when submitting a respective application. The Medical Device Authority...
Read More
Mar 20, 2021
EU MDR/IVDR
The Health Products Regulatory Authority (HPRA), the Irish regulating authority in the sphere of medicines and medical devices, has published a draft guidance document dedicated to new applications for wholesale distribution authorizations (WDAs), as well as...
Read More
Mar 20, 2021
Canada
Health Canada, the country’s regulating authority in the sphere of medical devices, has published updated guidance on incident reporting for medical devices. The present document supersedes the previous version issued by the authority earlier in October 2011. Due to...
Read More
Mar 20, 2021
FDA
The Food and Drug Administration (FDA) has published an information sheet guidance describing the regulatory aspects related to the Significant Risk and Nonsignificant Risk medical device studies. The document is intended to provide additional clarifications and...
Read More