Snapshot

The Marketing authorization of medical devices and diagnostics pathway has been developed by the of Tanzania.

This pathway can be used where Registrable Classes of the IVD such as Class A-registrable (supplied in sterile, active and have measuring function), B, C and D..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Target time assessment is 1. After receipt of the application, the Authority shall conduct a screening of submitted documents to confirm the completeness of submission before issuing an invoice for payment of the respective fees within 1 - 2 working days. Incomplete applications will be queried for additional data, and returned back to the applicant for rectifications. Applications for incorrect products applied for notifications will be rejected and returned to the applicant. Once the application has been accepted, an invoice shall be generated and sent to applicants via TMDA Traders’ Portal. 2. A complete application includes the product dossier and required product samples. Once TMDA receives a complete application, the application is scheduled for assessment. The time taken to schedule assessment is dependent on the complexity of the device and availability of assessors. Nevertheless, the scheduling stage may not exceed 10 working days for class A and B devices and 20 working days for class C and D devices. 3. Each process shall undergo first and second assessment whereby assessors shall review the documents to confirm whether the device complies with TMDA requirements of quality, safety and performance. The assessment stage is expected to take 23 working days for class A and B devices and 40 working days for class C and D devices. Note: Quality Audit of the manufacturing facilities is also incorporated into the assessment process however, the timelines reflected above do not include the time for conducting site inspections. 4. Quality assurance of the assessment reports shall be done to verify the recommendations and any request for additional data (queries). This stage is expected to take 5 working days for class A and B devices and 8 working days for class C and D devices. 5. After a final conclusion is reached and the product is recommended for registration or refused registration, the application undergoes administrative procedures. These procedures attaining approval from the Director General. This stage shall not exceed 5 days for class A and B devices and 25 days for class C and D devices. .