bio_subbu
Super Moderator
Medical Device Regulatory Guidelines – TFDA (Tanzania Food and Drugs Authority)
Dear All
I came across this TFDA’s (Tanzania Food and Drugs Authority) first draft document on "Guidelines on submission of documentation for registration of Medical devices”.
The guideline states that: “Regulation of medical devices involves amongst other things, registration, which is an official authorization for the purpose of marketing or free distribution after assessment of safety and performance”.
Also states that “In order to address various concerns from stakeholders and the general public, the Authority has decided to set up a framework for regulating medical devices in Tanzania. To begin with, the Authority has developed this guideline which defines requirements for registration of medical devices”. For more details find the attachment.
Regards
S. Subramaniam
Dear All
I came across this TFDA’s (Tanzania Food and Drugs Authority) first draft document on "Guidelines on submission of documentation for registration of Medical devices”.
The guideline states that: “Regulation of medical devices involves amongst other things, registration, which is an official authorization for the purpose of marketing or free distribution after assessment of safety and performance”.
Also states that “In order to address various concerns from stakeholders and the general public, the Authority has decided to set up a framework for regulating medical devices in Tanzania. To begin with, the Authority has developed this guideline which defines requirements for registration of medical devices”. For more details find the attachment.
Regards
S. Subramaniam
