Tanzania TMDA Sets 2027 Medical Device Retention Fee Dates
TMDA's 2027 annual retention notice sets a 1 November 2026 continued-marketing declaration deadline, a 31 January 2027 fee deadline (USD 200 per registered imported medical device or IVD and USD 50 per notified imported device or IVD under GN No. 686 of 2021), a 15% late-payment penalty window from 1 February to 31 March 2027, and registration suspension plus import-permit blocks from 1 April 2027.
Regulatory Update
The Tanzania Medicines and Medical Devices Authority (TMDA) published a public notice, Payment of Annual Retention Fees for the Year 2027, dated 28 July 2026 and posted on the TMDA portal on 1 October 2026. Issued by the Director General under Section 55(b) of the Tanzania Medicines and Medical Devices Act, Cap 219, the notice sets the 2026–2027 declaration, payment, late-penalty, registration-suspension, and import-permit deadlines for registered medicinal products, medical devices, and in vitro diagnostic devices (IVDs).
While the notice cross-references The Tanzania Medicines and Medical Devices (Fees and Charges) Regulations, 2021 without reprinting the tariff table, TMDA's official Fees and Charges Regulations, 2021 (Government Notice No. 686 of 2021) and Medical Devices Assessment Fees and Charges schedule specify the exact annual retention amounts and the late-payment penalty rate that apply to this cycle.
2027 Retention Calendar and Product Scope
The 28 July 2026 notice names all three regulated product categories — medicinal products, medical devices, and IVDs — in its invoice, declaration, and suspension sentences, while restricting its 12-month automatic cancellation sentence to medicinal products:
| Milestone | Date in the TMDA notice | Product scope stated in the notice | Regulatory consequence |
|---|---|---|---|
| Proforma invoice generation | By October 2026 | Registered medicinal products, medical devices, and IVDs | TMDA generates proforma invoices and transmits them to marketing authorization holders through their TMDA trader-portal accounts |
| Continued-marketing declaration | By 1 November 2026 | Registered medicinal products, medical devices, and IVDs | Marketing authorization holders must scrutinize the proforma invoices and submit the list of products they intend to continue marketing in 2027 |
| On-time retention fee payment | By 31 January 2027 | Declared products | Annual retention fee payable without penalty |
| Late-payment penalty window | 1 February 2027 to 31 March 2027 | Late retention payments | Payment attracts the 15% late-payment penalty prescribed under Regulation 4(7) of the 2021 Fees and Charges Regulations (GN No. 686 of 2021) |
| Registration suspension | By 1 April 2027 | Non-declared medicinal products, medical devices, and IVDs, plus declared products with unpaid retention fees | Registrations are suspended |
| Import-permit block | Effective by 1 April 2027 | Non-declared products and declared products with pending retention fees | Import permits will not be issued |
| Automatic revocation after 12 months of suspension | After more than 12 months of suspension | Named for "any medicinal product registration" only | The notice states that any medicinal product registration suspended for more than 12 months shall be automatically revoked or cancelled; medical devices and IVDs are not named in that sentence |
Prescribed Retention Fees and Late Penalty Under GN No. 686 of 2021
Under Regulation 4(1), Regulation 4(7), and the First Schedule of The Tanzania Medicines and Medical Devices (Fees and Charges) Regulations, 2021 (GN No. 686, published 24 September 2021), the annual retention fees and late-payment amounts for the 2027 cycle are:
| Category in GN No. 686 of 2021 (First Schedule) | Schedule reference | On-time annual retention fee (by 31 Jan 2027) | 15% late penalty under Regulation 4(7) | Total payable during 1 Feb – 31 Mar 2027 window |
|---|---|---|---|---|
| Registered imported medical devices (Classes A sterile/measuring, B, C, and D) | First Schedule, S/N 26 | USD 200 | USD 30 | USD 230 |
| Notified imported medical devices (Class A non-registrable) | First Schedule, S/N 27 | USD 50 | USD 7.50 | USD 57.50 |
| Registered imported diagnostics / IVDs (Classes A sterile/measuring, B, C, and D) | First Schedule, S/N 42 | USD 200 | USD 30 | USD 230 |
| Notified imported diagnostics / IVDs | First Schedule, S/N 43 | USD 50 | USD 7.50 | USD 57.50 |
| Domestic medical devices and domestic diagnostics / IVDs | First Schedule, S/N 11–17 & 28–34; TMDA Fee Schedule | None prescribed (marked NA on TMDA schedule) | Not applicable | Not applicable |
| Registered imported human/veterinary medicines and biologicals (for comparison) | First Schedule, S/N 6 | USD 300 | USD 45 | USD 345 |
Practical Implications for Manufacturers
Pure Global analysis:
- Audit trader-portal proforma invoices and file the continued-marketing list by 1 November 2026: Foreign manufacturers and their local representatives in Tanzania should verify that every active imported medical device and IVD registration or notification appears accurately on the TMDA trader-portal proforma invoice at the prescribed rate (USD 200 for registered imported devices/IVDs; USD 50 for notified imported devices/IVDs) and return the confirmed 2027 product list by 1 November 2026. Products omitted from the declaration face registration suspension and import-permit blocks on 1 April 2027 alongside declared products with unpaid invoices.
- Settle invoices by 31 January 2027 to avoid the 15% surcharge: Because Regulation 4(7) of GN No. 686 of 2021 imposes a flat 15% surcharge on late payments made between 1 February and 31 March 2027, multi-product portfolios should complete bank transfers and portal reconciliation well ahead of 31 January 2027.
- Keep the 12-month automatic cancellation rule scoped to the text: While registration suspension and the import-permit cutoff on 1 April 2027 apply to non-declared and unpaid medical devices and IVDs, the notice's automatic revocation rule after 12 months of suspension explicitly names "any medicinal product registration" only. Manufacturers tracking regional obligations across our regulatory updates should treat 1 April 2027 as a hard shipment and registration-status cutoff for Tanzania without over-reading the medicinal-product cancellation clause.
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