Control of advertisement and product promotion of Medical Devices
Section 68 of the Tanzania Medicines and Medical Devices Act Cap.219 restricts the promotion and advertisement of medicines, medical devices, invitro diagnostics and biocidals unless approved by the Authority.
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Types of promotional materials and Advertisements
Advertisements refer to any information that can promote the sale or use of medical device and in vitro diagnostic products including:
- Publication in newspapers, magazines, journals, or other periodicals
- Display of posters or notices
- Circulars, brochures, pamphlets, books, fliers or free samples to healthcare professionals
- Announcement made orally or by means of producing or transmitting light or sound
How TMDA regulates promotion and advertisements for medical devices
TMDA regulates and controls all information that is presented to users through the following means:
- Reviewing product information including label artwork and manuals that are presented during the market authorization process;
- Reviewing and approving all advertisements for medical devices and Diagnostics; and
- Monitor advertisements and taking regulatory decisions regarding all unauthorized and misleading adverts.
Why regulate promotional and advertisements for medical devices
TMDA regulates the promotion of medical devices and diagnostics in order to protect users from these false and misleading advertisements that may lead to:
- Increased adverse events following misuse of the device
- Users failing to get the desired outcome following use of the device
- Wastage of resources by using products that may not work as expected
- Reduce the public’s confidence in the Authorities that are in place to protect their health
Requirements
The product must be registered
Detailed requirements on application for approval of advertisement and promotion of regulated product
When and how to apply
The product must be registered
- Create a trader portal account
- Lodge an application online
- Processing is within 7 days