
TMDA Guidelines on Good Review Practices: Overview
The article outlines the key points of the regulatory approach applied in Tanzania when it comes to medical devices intended to be marketed and used in the country.
The article outlines the key points of the regulatory approach applied in Tanzania when it comes to medical devices intended to be marketed and used in the country.
The new article explains in detail the way the relevant principles and practices should be implemented in order to ensure the safety and proper performance of medical devices allowed for marketing and use in the country.
The new article provides additional details and extensive clarifications regarding the approach to the regulation of medical devices and diagnostic products.
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.