Feb 26, 2024
EU
The article provides a general overview of the regulatory concepts associated with demonstrating substantial equivalence for specific products intended to be marketed and used in the EU.
Read More
Feb 23, 2024
EU
The new article provides additional clarifications concerning the content of submissions associated with clinical investigations and modifications to it.
Read More
Feb 23, 2024
Serbia
The article describes in detail the approach to be applied when requesting changes to the existing medical device registration.
Read More
Feb 23, 2024
FDA
The new article highlights the aspects related to the applicability scope, and also provides definitions of the key terms and concepts.
Read More
Feb 23, 2024
Australia
The article highlights the critical points related to the regulatory requirements for quality management system audits and certification.
Read More
Feb 21, 2024
FDA
The article highlights the key points associated with factors to be considered when determining the eligibility of a medical device type for a third-party review program under the 510(k) framework.
Read More