Recall of Devices and Diagnostics

Section 65 of the Tanzania Medicines and Medical Devices (Control of Medical devices) Regulations, 2015, restrict the sell, offer or expose for sale or supply medical devices subjected to recall.

The recall of medical devices and In-vitro diagnostic devices serve as the means of preventing or removing of the products from the market or supply chain to reach consumers and sent back to the manufacturer. The usage of such product(s) may be injurious to the health or the product(s) uses would not perform as intended by the manufacturer.

Recall of medical devices and diagnostic devices may be initiated by TMDA, Manufacturer, Registrant or Market Authorization Holder after receiving complaints from customers or following identification of potentially life threatening products during Post Marketing Surveillance activities. The costs of recall shall be borne by manufactures, marketing authorization holders or Registrants.

Based on relative health risks of the medical devices and diagnostic devices, the recall may be classified as Class I, II and III. Class I recall is for medical devices and diagnostic devices with the highest risks, the recall of which should be completed within 14 days since receipt of the initial recall order. Class II recall is for moderate risk and recall should be completed within 21 days. Class III recall time limit is 30 days.

After completion of the recall exercise the product(s) manufacturer(s)/applicant will be required to do and submit to the TMDA the following:

  1. The report with results of the recall
  2. The risk evaluation report conducted to assess the impact of the defectiveness or possible defectiveness devices;
  3. The measures taken to prevent a recurrence of the problem.

More details on recall refer to the Tanzania Medicines and Medical Devices (Control of Medical devices) Regulations, 2015 and Guidelines for Recall, Handling and Disposal of Unfit Medicines

To see the list of recalls Click here.