Recall of Devices and Diagnostics

Recall of Medical Devices, Invitro Diagnostics & Laboratory Equipment

Regulation No. 65 of the Tanzania Medicines and Medical Devices (Control of Medical devices) Regulations, 2015 prohibits to sell, offer or expose for sale or supply medical devices products subjected to recall.

The recall of medical devices and In-vitro diagnostic devices serve as the means of preventing or removing unfit medical devices or in-vitro diagnostics from the market or supply chain to reach consumers by sending them back to 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.

After the assessment of relative health risks of the medical devices or in-vitro diagnostic devices, the recall may be classified as Class I, II and III. Class I recall is for incidences which have been identified to be of the highest risks, the recall of which should be completed within 14 days from the day of approval of the recall by the Authority. 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; and
  3. The measures taken to prevent a recurrence of the problem.

More details on recall are found in the Guidelines for Recall, Handling and Disposal of Unfit Medicines.