ANVISA
The new article covers the matters related to classification of personalised devices and provides additional clarifications in this respect.
Tanzania
The final article of the cycle provides clarifications regarding the remaining specific aspects addressed in the document, finalizing the overview of the existing legal framework and highlighting the key points to be taken into consideration by the parties involved.
Tanzania
The new article further elaborates on the requirements related to importation of medical devices, and also explains the way adverse events should be handled.
Tanzania
The new article describes the approach to be followed when it comes to the way the assessment process should be managed, as well as the matters related to marketing authorization and quality audits products should undergo in order to be allowed for marketing and use in the country.
Tanzania
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.
