EU
The article highlights the key points associated with the regulatory status of certain products placed on the EU market and also describes in detail the approach to be applied with respect to qualification.
HSA
The new article outlines specific aspects associated with the registration of medical devices intended to be marketed and used in Singapore, emphasizing the most essential matters to be considered to ensure compliance with the requirements set forth under the existing legal framework.
Saudi Arabia
The article highlights the critical points associated with the regulatory framework for surgical sutures intended to be marketed and used in Saudi Arabia.
Saudi Arabia
The article provides a general overview of the regulatory requirements for medical devices developed by healthcare institutions to meet their internal needs.
Saudi Arabia
The new article highlights the critical points associated with the concept of intended use and clarifies the approach to be applied concerning risks associated with in-house medical devices.
Canada
The new article describes in detail the authority’s review process when assessing applications related to medical devices.
