IVD Performance Evaluation Protocols in Tanzania

1. Key takeaways

Tanzania does not review in vitro diagnostics (IVDs) against a generic template. Instead, TMDA issues disease-specific laboratory performance evaluation protocols, and the protocols published on the TMDA publications page define the technical expectation for each covered assay type. The currently published protocols are:

March 2025: Protocol for Performance Laboratory Evaluation of SARS-CoV-2 Antigen Assays.

October 2025: Protocols for Performance Laboratory Evaluation of:

• Hepatitis C (HCV) Serology Assays
• Hepatitis B Surface Antigen (HBV)
• Combined HIV and SYPHILIS Serology Assays
• Malaria Plasmodium Falciparum (PF) and Malaria PF/Pan Antigen Rapid Diagnostic Tests
• Human Immunodeficiency Virus (HIV) Serology Assays

The companion general guidance is the Guidelines for Conducting Performance Evaluation of In-Vitro Diagnostic Devices Submitted for Marketing Authorization, dated June 2024. Together, the protocols and the guideline mean that an IVD dossier for Tanzania is built from the performance evaluation pathway, not from a clinical evaluation template borrowed from other device categories.

2. Legal basis

3. Expert insights

Insight one: protocol-per-disease means that one generic performance report will not carry an IVD through Tanzania.

TMDA has issued separate protocols for six categories of assays. These documents are not advisory guidance; they are evaluation protocols, which typically fix the composition of the sample panel, the reference method, the acceptance criteria, and the statistical approach. Class D IVDs, such as HIV screening of blood donors and HIV diagnostics, sit in the highest public health priority tier in Tanzania, and preparing verification data according to the corresponding protocol is the substantive gate of the technical review. Filing a study design that ignores the protocol invites information requests and delay.

Insight two: Regulation 11(k) imposes a separate statutory requirement for near-patient IVDs, predating the 2024 guidance.

Regulation 11(k) provides that for a near-patient IVD, detailed information must be submitted on investigational testing carried out using the device, with human subjects representative of the intended users, under conditions similar to those of use. This provision targets self-testing and point-of-care scenarios and calls for human factors and usability data generated with real users, which is a different dimension from analytical laboratory performance. Both dimensions must be planned at the outset of the project.

Insight three: clinical performance for IVDs and clinical evidence for non-IVD devices are two separate regimes.

Part VII §1 states expressly that the non-IVD clinical evidence guidance does not apply to IVDs, which must follow the performance evaluation pathway. Part III sets the submission requirements for IVDs and Part VI sets the IVD classification rules. GRZAN never cites Part VII in an IVD project, precisely to avoid structural misplacement of the dossier, which reviewers notice quickly.

Insight four: malaria, HIV, HBV, HCV and syphilis are the five highest public health priorities in Tanzania.

The official classification examples place HIV screening of blood donors and HIV diagnostics in Class D, and malaria in Class C. The list of protocols overlaps heavily with the high-risk diseases in the official classification examples. That is not coincidence: the regulator concentrates its resources on the categories with the greatest public health impact, and sponsors should expect the deepest scrutiny exactly there.

Insight five: the SARS-CoV-2 antigen protocol of March 2025 is the earliest of this series.

Issued as a stand-alone document after the regulatory experience accumulated with pandemic-related products, it shows that Tanzania will issue dedicated protocols for categories linked to public health emergencies. Sponsors should expect further disease-specific protocols to appear and should track the TMDA publications page as part of project planning, since a new protocol changes the data requirements for any pending file.

4. Practical recommendations

1. At project start, first confirm whether a laboratory performance evaluation protocol exists for the target analyte; if it does, design the studies to that protocol.
2. Where no protocol exists for the disease, prepare the performance data under the general performance evaluation guideline of June 2024.
3. For near-patient or self-test IVDs, prepare the investigational testing data required by Regulation 11(k) and submit it alongside the laboratory performance data.
4. Do not reuse a non-IVD clinical evaluation report (CER) for an IVD; follow the performance evaluation pathway instead.
5. Track protocol updates on the TMDA publications page, because new protocols change the dossier requirements.

5. Verification checklist

• □ It has been confirmed whether the target assay has a corresponding laboratory performance evaluation protocol (six exist at present: HIV, HCV, HBV, HIV plus syphilis, malaria, and SARS-CoV-2).
• □ Performance data have been prepared under the corresponding protocol or the general guideline of June 2024.
• □ For near-patient or self-test IVDs, the Regulation 11(k) investigational testing details are ready.
• □ The IVD follows the performance evaluation pathway and does not apply the non-IVD clinical evidence guidance (Part VII §1).
• □ The IVD classification (Part VI) and fee tier (IVDs use a four-tier schedule) have been confirmed.
• □ A tracking mechanism for protocol updates is in place.

Regulatory information verified as of 29 October 2026. All content cited in this document was checked against the TMDA publications page, the June 2024 Compendium Part III, Part VI and Part VII §1, and GN. No. 315, Regulation 11(k), and will be re-reviewed when the regulations are updated.

• Local resources in Tanzania: GRZAN can coordinate a licensed Local Responsible Person (LRP) and distributor resources, covering online submission, sample delivery, quality audit support, and port clearance.
• Service capabilities: classification determination, route selection between registration and notification, technical documentation (CSDT/STED) preparation and localization, GMDN coding and grouping strategy, clinical evidence organization, software and AI-enabled device submissions, change management, vigilance and PMS reporting, and annual retention fee and renewal management.
• Contact GRZAN for registration documentation and conformity support for the Tanzania market: info@grzanglobal.com.