ANVISA
The new article highlights certain specific aspects related to the regulatory status of personalised devices allowed for marketing and use in Brazil.
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.
