EU
The new article describes in detail the approach to be applied when it comes to the re-assessment of designation under the new regulatory framework.
EU
The new article highlights certain specific aspects associated with designation, such as notification procedure or changes to the scope of designation.
Canada
The present article highlights the key points related to the changes the Canadian authority intends to introduce in order to mitigate the risks associated with potential shortages in the supply of healthcare products intended to be marketed and used in the country.
Australia
The article provides an overview of the official notice describing the changes to the Australian regulatory framework for medical devices.
EU
The new article clarifies the aspects associated with the designation decision to be taken with respect to the applicant entity in the context of the CAB/NB designation process.
RegDesk is recognized as a Regulatory Intelligence Representative Vendor! Learn more by reading the 2024 Gartner® Market Guide for Regulatory Intelligence Solutions.
Get the report
