Health Canada Guidance on Medical Device Recalls: Roles and Responsibilities
The new article clarifies the recall procedure in the context of the roles and responsibilities of the parties involved.
The new article clarifies the recall procedure in the context of the roles and responsibilities of the parties involved.
The article describes in detail the transitional arrangements associated with the recent regulatory changes in the European Union.
The article describes in detail the regulatory approach to be applied in the context of the importation and distribution of medical devices in the EU, focusing on the obligations of the parties involved.
The article highlights the key points associated with interpreting specific regulatory provisions of the current European legislation in medical devices.
The new article highlights the aspects related to the content of the clinical investigation report, discusses additional considerations associated with the transitional period, and explains the status of a legal representative.
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