Control of advertisement and product promotion of Medical Devices
Section 68 of the Tanzania Medicines and Medical devices (Control of Medical Devices) Regulations, 2015 restrict promotion and advertisement of medical devices, Invitro diagnostics unless it has been approved by the Authority.Promotion if not carried out correctly, may pass the wrong information and exaggerated claims hence misleading the consumer regarding the safety and performance of the medical devices, in-vitro diagnostics devices and laboratory equipment. In this regard: -
Medical devices, in-vitro diagnostics devices and laboratory equipment promotion activities is done in accordance with;
To apply for approval of promotional material applicant is required to submit to TMDA the following:-
The approval issued to an advert or promotion material is valid for two (2) years, after which it is subject for renewal. As part of control, all advertisements for medical devices, in-vitro diagnostic devices and laboratory equipment are monitored on daily basis.