Annual Retention Fees for Registered and Notified Devices in Tanzania

1. Key takeaways

The annual retention fee is the first hard annual obligation after certification in Tanzania, imposed by Regulation 17(2) of GN 315:

Every registrant shall, in addition to the fees related to registration of each medical device, pay annual retention fees before 31st January of each calendar year.

In other words: the fee is payable before 31 January every year.

Three accompanying rules:

• Regulation 17(1): in the provision setting the five-year validity of a registration, the text states subject to payment of prescribed annual retention fees — payment is a condition of validity, not an extra step.
• Regulation 17(6): a defaulter after the grace period has expired must pay a penalty in accordance with the prevailing fees and charges regulations.
• Regulation 18(g): where a registrant fails to pay the prescribed retention fee within the prescribed time, TMDA may suspend or cancel the registration.

Rates (TMDA website fee schedule, import side): registered devices USD 200 per year; notified devices USD 50 per year.

2. Legal basis

3. Expert insights

Insight one: payment is a condition of validity, and this wording changes the nature of the legal relationship.

Regulation 17(1) embeds subject to payment of prescribed annual retention fees directly into the wording of the five-year validity; Part I §5.1 likewise lists Payment of annual retention fees as the first of the conditions on which the validity of a registration depends. This means that during any period of arrears, whether the certificate remains valid must be confirmed with TMDA rather than presumed. GRZAN treats any arrears as an open compliance exposure in client advisories, pending verification with the authority.

Insight two: the Tanzanian retention fee is not tiered by risk class, in contrast with Kenya.

Tanzania charges USD 200 for registered and USD 50 for notified devices — the only distinction is the form of authorization. Kenya’s PPB, by contrast, tiers by class: Class A/B at USD 50 and Class C/D at USD 300. The annual holding cost structure for the same product from the same company differs across the two neighbouring countries, so an East African multi-country budget cannot simply be copied from one market to the other.

Insight three: on 1 October 2026, TMDA already published the payment notice for the 2027 annual retention fees.

This is a feature of the Tanzanian system: the payment notice for the following year’s retention fees is issued in October of the preceding year. Companies should treat October as the trigger month for the retention fee cycle, not January. Aligning the internal budget approval, payment execution, and receipt archiving to that October trigger removes the year-end scramble entirely.

Insight four: the legal consequence of arrears is that TMDA may suspend or cancel, not automatic lapse.

The structure of Regulation 18 is that the Authority may suspend or cancel the registration if the Authority has reasonable grounds to believe that the registrant has failed to pay. Arrears therefore trigger a discretionary power, and, combined with the procedural requirements of Regulation 20 (written notice, corrective period, opportunity to be heard), companies have a remediation window. The penalty under Regulation 17(6) is the separate financial consequence of lateness.

Insight five: the retention fee and the renewal fee are two separate payments.

Regulation 17(2) states in addition to the fees related to registration of each medical device — the retention fee is on top of the registration fee. In year five, a renewal involves paying both that year’s retention fee and the renewal-related fees under the Fees and Charges Regulations. Budgets that merge the two lines systematically understate the true cost of year five.

4. Practical recommendations

1. Set 31 January as the fixed annual milestone and start preparation in October, when TMDA publishes the payment notice for the following year.
2. Accrue the budget annually at USD 200 for registered and USD 50 for notified devices, denominated in US dollars (a separate TZS rate applies on the local side).
3. After payment, retain the receipt and a screenshot of the payment status in the TMDA portal as evidence against any Regulation 18(g) allegation.
4. Do not merge the retention fee and renewal fee into one budget line — both fall due in year five.
5. If already overdue, pay immediately and anticipate the penalty under Regulation 17(6); at the same time, confirm the certificate status in writing.

5. Verification checklist

• □ The annual milestone is on record: annual retention fees payable before 31 January each year (Regulation 17(2)).
• □ Budget accrued at USD 200 (registered) and USD 50 (notified).
• □ The applicable local TZS rate has been confirmed (for local manufacturing).
• □ Payment receipts and portal status screenshots are retained.
• □ The consequences of arrears are understood: penalty under Regulation 17(6) plus possible suspension or cancellation under Regulation 18(g).
• □ Year five budgets include both the retention fee and the renewal fee (Regulation 17(2), in addition to).
• □ The TMDA public notice for the 2027 annual retention fees, published on 1 October 2026, has been tracked.

Regulatory information verified as of 29 October 2026. All provisions cited in this document were checked against the official TMDA published texts (GN. No. 315, Regulation 17 and Regulation 18(g); the TMDA website fee schedule; the TMDA public notice of 1 October 2026) 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.