
TMDA Guidelines on Good Review Practices: MD Regulation
The new article provides additional details and extensive clarifications regarding the approach to the regulation of medical devices and diagnostic products.
The new article provides additional details and extensive clarifications regarding the approach to the regulation of medical devices and diagnostic products.
The new article provides additional clarifications regarding the specific scope of information-related obligations medical device manufacturers should comply with.
The article highlights the key points related to the manufacturers’ obligations in case of product supply being interrupted or discontinued.
The article outlines the basics of the regulatory framework for innovative medical devices.
The final article of the cycle clarifies certain specific regulatory matters associated with submissions, such as the applicability of transitional provisions or modifications to submissions and the way they should be introduced.