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: -

  1. Promotion activities are done with respect to products that have been registered by the TMDA.
  2. TMDA is responsible for regulating the labelling and advertising of products in order to adequately safeguard consumers from false or misleading promotion.
  3. TMDA regulates:
    1. Advertisements of medical devices, in-vitro diagnostics devices and laboratory equipment
    2. Manufacturer-sponsored symposia
    3. Trade shows
    4. iv) Public/patient disease awareness programmes not related to any medical devices, diagnostics devices and laboratory equipment. Though these are not considered to be promotional activities, however, such activities should adhere to the highest standards in terms of accuracy of information.

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:-

  1. Completely filled, signed and stamped application form for approval of promotional materials.
  2. Hard or soft copies of advertisements

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.