Tanzania IVD Classification: Individual Risk and Public Health Risk Axes

1. Key takeaways

In vitro diagnostic devices (IVDDs) in Tanzania reuse the A/B/C/D four-class naming, but the assessment axis differs from non-IVD devices: IVDs are classified along the two dimensions of individual risk and public health risk, not by the invasiveness or energy form of the device itself. A self-test kit with no physical contact with the body can therefore sit in a higher class than an invasive instrument, because what matters is the consequence of a wrong result for the patient and for the population.

The class examples for IVDs given on the TMDA website procedure page are as follows:

The specific rules are set out in Part VI of the June 2024 Compendium, the guidance on IVD classification; the rules for non-IVD devices are in Part V. The two parts must never be mixed: applying the non-IVD rule set to an IVD, or the reverse, produces a wrong class and a rejected submission. Teams accustomed to EU IVDR logic will find the Tanzanian structure familiar, but the fee tiers and timelines differ, as described below.

2. Legal basis

3. Expert insights

Insight 1: The public health risk axis naturally pushes infectious-disease tests upward.

Tests for malaria, HIV, HBV, HCV, syphilis and SARS-CoV-2 address high-priority public health topics in Tanzania, and the official examples place HIV blood donor screening and HIV diagnosis directly in Class D. This matches the EU IVDR logic, under which HIV donor screening is also Class D, but for manufacturers entering the African market for the first time it arrives as a cost shock: Class D goes through registration (notification is impossible), with an independent laboratory performance evaluation protocol on top of the standard dossier.

Insight 2: Tanzania has already turned IVD performance evaluation into disease-specific protocols.

TMDA published laboratory performance evaluation protocols in two batches, in March 2025 and October 2025, covering SARS-CoV-2 antigen (March 2025) and HIV serology, HCV serology, HBV surface antigen, HIV plus syphilis combined serology, and malaria PF and PF/Pan antigen rapid tests (October 2025). These are not general guidelines but evaluation protocols drafted per disease — meaning that Class D IVDs face clearly defined experimental designs to follow in the technical review in Tanzania. Building the validation data set around the relevant protocol from the start avoids a costly redo of laboratory work.

Insight 3: Fee tiers for IVDs differ from non-IVDs, with the IVD scale set class by class.

According to the TMDA website fee schedule: for non-IVDs, both Class C and Class D are charged USD 2500, while IVDs are charged class by class — Class A at 300, Class B at 1000, Class C at 1500 and Class D at 2000 US dollars, with a distinct tier for each of the four classes. The processing time for IVD Class D is also shown separately as 10 days (the other IVD classes are shown at 45 days, as are all non-IVD classes) — this 10-day entry deviates sharply from the adjacent columns. GRZAN recommends confirming against the invoice and acceptance receipt issued by TMDA and not using this figure as a scheduling basis, pending verification.

Insight 4: Self-testing products are the sensitive zone of the class table.

Pregnancy self-testing is listed in the official examples as Class B (moderate individual risk / low public health risk), while blood glucose self-testing is listed as Class C (high individual risk / moderate public health risk). Both are self-tests, yet they differ by two classes because the clinical consequences of a wrong result differ. GRZAN notes that self-testing products must also layer on the labelling language requirement — household-use devices must use Swahili (see article 23 of this series). Budget the localization work at project start, not after approval.

4. Practical recommendations

1. Run a two-axis scoring before starting any IVD project: assess individual risk and public health risk separately, then take the higher tier.
2. Plan budget and schedule for infectious-disease IVDs directly at the higher class — do not first assume a low class and wait for TMDA to correct it.
3. For Class D IVDs, obtain the laboratory performance evaluation protocol for the relevant disease early and prepare the validation data according to its experimental design.
4. Start Swahili labelling and IFU localization at the same time for self-testing IVDs; this is a hard requirement at the labelling stage, not a nice-to-have.

5. Verification checklist

• □ The self-assessment has been completed on the two axes of individual risk and public health risk.
• □ The specific classification rules of Part VI have been applied (not the non-IVD rules).
• □ Whether the test relates to an infectious disease has been confirmed, and any upward shift of the class verified accordingly.
• □ The laboratory performance evaluation protocol for the relevant disease has been obtained, where applicable.
• □ The difference in fee tiers between IVDs and non-IVDs has been confirmed (IVDs are tiered class by class).

Regulatory information verified as of 29 October 2026. All provisions cited in this article were checked against the texts officially published by TMDA (Section 5 of GN. No. 315, Part VI of the June 2024 Compendium, and the TMDA website procedure and fee pages); the content is re-reviewed whenever the regulations are updated.

• Local resources in Tanzania: GRZAN can coordinate licensed local responsible persons (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 device submissions, change management, vigilance and PMS reporting, annual retention fees and renewal management.
• Contact: hito.lin@grzan.cn; website www.grzan.cn.