Tanzania Medical Device and IVD Fees: USD Import and TZS Local Rate Tables

1. Key takeaways

Device fees in Tanzania are governed by the Tanzania Medicines and Medical Devices (Fees and Charges) Regulations, 2022 (as stated on the TMDA website), with two separate rate schedules: local manufacturing (TZS) and imports (USD). The import-side (USD) rates and processing times published on the TMDA page “Medical Devices Assessment Fees and Charges” are as follows.

Medical Devices

In vitro diagnostic devices (IVD)

2. Legal basis

3. Expert insights

Insight 1: Class B and Classes C/D carry the same registration fee of USD 2500 — the value of classification shows in review time and quality audits, not in the application fee.

For non-IVDs the fee schedule merges Classes B, C and D into one tier at USD 2500, with only Class A reduced to USD 500. This contrasts with the IVD scale, which is tiered class by class (300 / 1000 / 1500 / 2000). GRZAN notes: do not underestimate the total cost of a Class D device because its application fee equals that of Class B — the real differences lie in whether a site audit is triggered, in the review baseline (43 versus 93 working days) and in the depth of clinical evidence.

Insight 2: Local manufacturing rates are markedly lower and are denominated in Tanzanian shillings.

Local side: notification at TZS 50,000, Class A at 100,000, Class B at 200,000, and Classes C/D at 500,000 TZS. This is Tanzania’s price instrument to encourage local manufacturing. For companies with a manufacturing entity in Tanzania the rate advantage is obvious, but note the requirement of Part IV §3.2.3 — a domestic manufacturer must be registered with TMDA before notifying its products, and parties participating in final manufacturing steps such as assembly, resizing, cutting and packaging all count as manufacturers.

Insight 3: Annual retention fees split only two ways, USD 200 for registered and USD 50 for notified, regardless of risk class.

This differs from Kenya, which tiers by A/B versus C/D (USD 50 / 300). Tanzania’s retention fee distinguishes only the form of authorization, not the risk class. Section 17(2) of GN 315 requires payment by 31 January each year; Section 17(6) provides that a defaulter after the grace period expires must pay a penalty under the current fees regulations. Budgeting the retention fee as a small annual line item is easy; forgetting it costs the certificate.

Insight 4: The “10 days” processing time for IVD Class D must be treated with caution.

On the TMDA website fee schedule, the processing time for IVD Class D registration is shown as 10 days, while IVD Classes A/B/C and all non-IVD classes are shown at 45 days. The figure diverges sharply from the four-stage timelines of Compendium Part I §3.4 (approximately 93 working days for C/D). GRZAN judges that this entry may contain a data-entry problem: the 10-day figure is not cited externally; the four-stage timelines of the Compendium are used throughout, pending verification, with written confirmation from TMDA recommended.

Insight 5: Fees are non-refundable without exception, and bank charges come on top.

Part I §3.4.3: “All fees are non-refundable”; payment must be made through the control number generated on the TMDA invoice; for bank transfers all bank charges are borne by the applicant. Section 7(2)(a) of GN 315 likewise provides that application fees follow the fees regulations in force at the time of application and are not refundable. This means that where an application is rejected for the wrong route, deemed withdrawn, or withdrawn voluntarily, no fee is returned.

4. Practical recommendations

1. Budget on the import + high-class ceiling: USD 2500 for non-IVD Classes B/C/D; USD 2000 for IVD Class D.
2. Accrue the annual retention fee yearly at USD 200 (registered) / USD 50 (notified), and complete payment by 31 January each year.
3. Accrue variation fees separately: USD 300 for major and USD 150 for minor variations (IVD: 500 / 200); where multiple variations are combined, charging follows the highest category (see article 39).
4. Do not cite the 10-day timeline for IVD Class D; use the four-stage timelines of the Compendium instead.
5. Send the advice note after every payment, stating the applicant’s name, the device names and the amount; quote the registration number where the device is registered.

5. Verification checklist

• □ The applicable rate schedule has been confirmed: import (USD) or local (TZS).
• □ The difference between the device and IVD fee tables has been confirmed (non-IVD merges B/C/D; IVD tiers class by class).
• □ Annual retention fees accrued: 200 USD for registered / 50 USD for notified.
• □ Fees confirmed non-refundable, with bank charges additional.
• □ The 10-day processing time for IVD Class D is not cited in external documents (known data problem).
• □ The advice note has been sent after payment, quoting the registration number where required.

Regulatory information verified as of 29 October 2026. All data cited in this article were checked against the TMDA website page “Medical Devices Assessment Fees and Charges” and the Tanzania Medicines and Medical Devices (Fees and Charges) Regulations, 2022; GN 315 provisions were checked against the officially published text. 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.
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