Disposal of Unfit Devices and Diagnostics
Once medical devices deemed unfit for public consumption has to be disposed. Section 59 of the Tanzania Medicines and Medical Devices (Control of Medical devices) Regulations, 2015, prohibit the disposal of unfit medical devices and In-vitro diagnostic devices without the approval from the TMDA
Disposal of medical devices and diagnostic devices that do not meet quality requirements may be initiated by TMDA, regional, district and hospital pharmacist, owner or in-charge of facility or premises, superintendent or an Inspector.
When disposal of medical devices and diagnostic devices is initiated by TMDA following confiscation of the products during inspection, the owner shall be required to incur the cost of disposal by payment of 25% of the total cost of products as per fees and charges regulations
When disposal of medical devices and diagnostic devices is initiated voluntarily, no disposal cost are paid to TMDA except payment to the disposal facility.
To apply for disposal of unfit medical devices, In-vitro diagnostic and Laboratory equipment submit to TMDA the following document:-
- Completely filled in, signed and stamped application form for disposal.
- Complete list of the medical devices and diagnostic to be disposed with the following information;
- Trade name of the product
- Common name of the product
- Packaging material
- Quantity of the product to be disposed
- Name of the Manufacturer
- To create a platform for information sharing on the harmonized medicines registration system to key stakeholders at national and regional level
- Lot/ Batch number/product code of the product
- Current valid market value of each product to be disposed
Disposal of medical devices and diagnostic devices shall be done by methods proposed by National Environment Management Council (NEMC) and supervised by TMDA. During disposal Members involves include:-
- TMDA inspectors,
- NEMC officer/ representative from NEMC,
- Police officer,
- Representative from local government office, and
- Any other office deem necessary for the disposal procedure(if applicable)
After disposal, TMDA issues disposal certificate. For more details regarding requirements and procedures for disposal refer to Guidelines for Recall, Handling and Disposal of Unfit Medicines.