TMDA Annual Retention Fees 2027: Pay by 31 January or Face Suspension

TMDA annual retention fees keep a registered medicine, medical device or in vitro diagnostic (IVD) on the Mainland register. The Tanzania Medicines and Medical Devices Authority (TMDA) has published its notice for the 2027 cycle. It sets a payment deadline of 31 January 2027, a penalty window to 31 March 2027, and suspension from 1 April 2027. The first step, the product declaration, closed on 1 November 2026. This update reads the notice and the fees regulations directly and explains what a late declarer can do.

The notice is dated 28 July 2026 and was posted on the TMDA website on 1 October 2026. Pure Global, a regulatory intelligence firm, reported it on 27 October 2026. We read the TMDA notice on payment of annual retention fees for the year 2027 ourselves before writing.

What changed for the 2027 cycle?

Retention fees are not new. What is new is the sequence and the consequences TMDA now spells out. The notice for 2024, dated 23 November 2023, told companies to collect invoices from TMDA offices and pay by 31 January 2024. Its only stated sanction was that import permits would not be issued for unpaid products. You can compare it in the TMDA notice for the year 2024.

The 2027 notice adds four things:

• Proforma invoices are generated by TMDA and sent to holders through their trader portal accounts, by October 2026.
• Holders must first declare which products they wish to continue marketing, by 1 November 2026.
• Late payment in February and March 2027 attracts the penalty in the fees regulations.
• From 1 April 2027, registrations of undeclared products, and of declared products still unpaid, are suspended. A medicinal product registration suspended for more than 12 months is revoked automatically.

The declaration step matters most. It turns the annual fee into an annual choice. A product you do not declare is treated as one you no longer wish to market.

What are TMDA annual retention fees?

A TMDA registration certificate does not stay live on its own. The Act makes registration subject to payment of a prescribed annual retention fee. The fee keeps the product on the register for the coming year. A 2024 amendment text published by TMDA adds that the fee also funds post-marketing surveillance of medical products on the Tanzanian market.

The amounts sit in the First Schedule to the Tanzania Medicines and Medical Devices (Fees and Charges) Regulations, 2021, GN 686 of 2021. The schedule has separate retention rows for imported medicines, imported medical devices, imported diagnostics and imported antiseptics and disinfectants. Devices and diagnostics are split into registered and notified products. The schedule prints no retention row for domestically manufactured medicines, devices or diagnostics.

We have not printed the dollar amounts here. Zatra quotes government fees only from its fee register, and the register lines for these TMDA retention rows could not be confirmed for this update. Your proforma invoice on the trader portal is the figure that governs. The schedule rows to check are listed under "Figures to confirm" below.

Regulation 4(5) lets fees be paid in Tanzanian shillings or in US dollars or another convertible currency equal to the shilling amount on the day of payment.

What the law says

Three instruments carry the rules.

The Tanzania Medicines and Medical Devices Act, Cap. 219. The Act was renamed by the Finance Act, 2019 (No. 8 of 2019), which came into operation on 1 July 2019. Part VIII of that Act replaced "Tanzania Food, Drugs and Cosmetics" with "Tanzania Medicines and Medical Devices" and renamed the Authority TMDA. The notice relies on section 55(b), which lets the Authority act where the annual retention fee has not been paid.

A consolidated text on TanzaniaLaws (Cap. 219 consolidation) numbers that ground as section 55(1)(b). The same text provides that a registration certificate is valid for five years, subject to payment of prescribed annual retention fees. It also requires written notice before cancellation, with one month for the holder to make representations. That text is an unofficial consolidation, so the section numbers should be confirmed against the current revised edition of the Act.

GN 686 of 2021. The fees regulations were signed on 6 September 2021 and published on 24 September 2021. The official record is on TanzLII, GN 686 of 2021. Regulation 4(1) requires anyone doing business in regulated products to pay the First Schedule fees. Regulation 4(7) sets the late payment penalty at fifteen percent of the total amount payable.

The 2027 notice. It fixes the dates for this cycle and states the suspension and revocation consequences. It does not reprint the fee amounts. It refers to the 2021 regulations for the penalty.

TanzLII also lists an amendment, GN 5 of 2023, made in December 2022. Its text could not be read for this update. TMDA's site also hosts a 2024 amendment text dated March 2024 that substitutes new schedules. That text shows no Government Notice number. We discuss below why that matters for notified devices.

Who is affected?

The notice is addressed to marketing authorisation holders of registered medicinal products, medical devices and IVDs on the Mainland. In practice that means:

• Foreign manufacturers that hold registrations through a local technical representative.
• Local agents and distributors who manage registrations on a principal's behalf.
• Importers whose import permits depend on the product staying registered.
• Hospitals, laboratories and NGOs that import registered devices or diagnostics directly.
• Local manufacturers, who should confirm that the schedule prints no retention row for their products.

If you are still at the registration stage, read our guide to registering medicines and medical devices with TMDA first.

Which products does the notice cover, and which does it not?

The notice names registered medicinal products, medical devices and IVD devices. It says nothing about premises, food or cosmetics. The table sorts the common cases.

The Finance Act 2019 moved food and cosmetics to the Tanzania Bureau of Standards. Part VII of that Act inserted food and cosmetics parts into the Standards Act, Cap. 130. News Central TV reported on 30 August 2019 that cosmetics regulation had moved to the standards bureau. A cosmetics importer therefore deals with TBS, not TMDA. Our guide to product standards certification with TBS covers that route.

Premises are a separate gate. A retail pharmacy, a wholesaler and an importer each hold a premises permit or registration that renews on its own cycle. Our guide to pharmacy and medical practice licensing explains which body handles which class. Paying product retention fees does not renew a premises permit.

How much is the late payment penalty?

Regulation 4(7) of GN 686 of 2021 sets the penalty at fifteen percent of the total amount payable. The notice applies it to payments made from 1 February to 31 March 2027. The regulation does not set the window; the notice does.

The penalty is charged on the total amount payable, not on a portion. A holder who pays one day late pays the full 15% on top. There is no sliding scale by days late in the text we read.

Payment after 31 March 2027 is not described in the notice as a further penalty band. It is described as suspension. Treat 31 March 2027 as the last date on which paying keeps the registration active without interruption.

What should a late declarer do now?

The declaration deadline was 1 November 2026. If you missed it, the notice does not say whether TMDA will accept a late list. It also does not say a late list will be refused. Its stated consequence for undeclared products arrives on 1 April 2027: suspension of the registration and no import permits.

That leaves a window of five months. Within what the sources support, a late declarer should:

• Write to TMDA now, through the trader portal or by email to the address on the notice, listing each product you wish to keep marketing. Record the date and keep the acknowledgement.
• Check whether your proforma invoice already lists those products. If it does, pay it by 31 January 2027.
• If the invoice omits a product you want to keep, ask TMDA in writing to add it or issue a supplementary invoice.
• Do not assume silence means acceptance. Follow up before the end of January.

If a registration is later suspended or a cancellation notice arrives, the Act provides for written notice and a chance to make representations before cancellation. Representations, appeals and any dispute with the Authority belong with an advocate. Zatra prepares the file and routes the matter.

What happens on 1 April 2027?

Three things follow from the notice.

1. Registrations of undeclared or unlisted products are suspended.
2. Registrations of declared products with unpaid retention fees are suspended.
3. Import permits are not issued for undeclared products or for declared products with fees still pending.

The fourth consequence applies later. A medicinal product registration that stays suspended for more than 12 months is revoked or cancelled automatically. The notice names medicinal products only in that sentence. Pure Global's report reads it the same way: medical devices and IVDs are not named in the revocation provision. Device holders should not read that as safety. A suspended device still cannot be imported, and the Act's general cancellation power remains.

The import permit block reaches the border. A consignment shipped in March for a product that is suspended on 1 April may arrive with no permit to clear it. Plan shipments around the payment date, not the arrival date. Our note on import and export compliance sets out the other border documents.

Is the notified device fee the same in every TMDA document?

Not in the documents we read. GN 686 of 2021, as published in September 2021, sets one retention figure for notified devices and notified diagnostics. TMDA's own medical devices fees and charges page shows the same figure. The March 2024 amendment text on the TMDA site prints a lower figure for the same rows.

We could not find a Government Notice number for the 2024 text, so we cannot say whether it is in force. TMDA's fees and charges regulations page lists only GN 686 of 2021. For notified products, pay the amount on your TMDA invoice and ask TMDA which schedule it applied. Registered device, registered diagnostic and medicine rows are the same in both texts.

Mainland and Zanzibar: who regulates what?

The TMDA notice covers the Mainland register. Zanzibar has its own law and its own agency. The Zanzibar Food, Drugs and Cosmetics Act, 2006 provides for regulation of food, drugs, medical devices, cosmetics, herbal drugs and poisons in Zanzibar. The Policy Vault record of the Zanzibar Act sets out its scope. The Daily News described the Zanzibar Food, Drugs and Cosmetics Agency as responsible for food, medicines and cosmetics in a 30 June 2026 enforcement report.

Paying TMDA keeps the Mainland registration alive. It does nothing for a ZFDA registration. Our guide ZFDA, not TMDA, for food, drugs and cosmetics in Zanzibar covers the island route. Check ZFDA's renewal terms on the ZFDA website or with the Agency directly.

Worked example: a hypothetical device importer that pays late

Pwani Diagnostics Ltd is a hypothetical Dar es Salaam importer. It holds registrations for 14 imported products. Its trader portal shows a proforma invoice. For this illustration, assume the invoice total is USD 3,200. That total is invented for the arithmetic and is not a schedule rate.

Scenario A: it pays on 28 January 2027. It pays USD 3,200. No penalty applies.

Scenario B: it pays on 12 February 2027. The penalty is 15% of the total amount payable.

• Penalty: 3,200 × 0.15 = USD 480.
• Total: 3,200 + 480 = USD 3,680.

Being 12 days late costs USD 480, which is 15% of the invoice.

Scenario C: it missed the 1 November declaration for two products. Assume those two products account for USD 400 of the illustrative total. If TMDA does not add them, they are suspended on 1 April 2027 and no import permit issues for them. Pwani's other 12 products stay registered if their USD 2,800 is paid by 31 January 2027.

The cheapest path is Scenario A. Note the currency rule too. If Pwani pays in shillings, regulation 4(5) uses the shilling equivalent on the day of payment.

Retention fees are separate from border taxes. Pharmaceuticals sit in EAC Common External Tariff band 1 at 0% import duty (register line F0304). That rate does not reduce or replace the TMDA retention fee.

What to do now

1. Open the portal. Log in to your TMDA trader portal account and download the proforma invoice issued for 2027.
2. Reconcile the list. Compare the invoice with your register of products and principals. Mark every product you want to keep and every product you will let lapse.
3. Close the declaration gap. If you missed 1 November 2026 or omitted a product, write to TMDA now and keep proof of the request.
4. Pay by 31 January 2027. Pay the invoiced amount through the payment route TMDA gives on the invoice. Keep the receipt with the invoice.
5. Align shipments. Do not ship a product whose fee is unpaid to arrive after 31 March 2027. Its import permit will not issue.
6. Check premises and Zanzibar separately. Renew premises permits on their own cycle, and handle any ZFDA registration directly with ZFDA.

Key dates

The independent report by Pure Global, 27 October 2026 gives the same dates and the same 15% penalty.

How Zatra helps

Zatra handles TMDA retention as part of our sector business permits service. We reconcile your product list against the portal invoice and draft the late declaration letter. We track payment to the receipt and line up premises renewals and import permits. For importers, our import and export compliance service keeps shipments in step with registration status.

Government fees are paid to TMDA at the official rate against its invoice. They are separate from Zatra's professional fee and are never marked up. Zatra prepares and coordinates. It does not decide or guarantee any authority's outcome. Representations against suspension or cancellation, appeals, product seizure, prosecution and formal legal opinions go to an advocate. We work with one on your file.

Sources and status

Accurate as at 2 November 2026.

• Payment of Annual Retention Fees for the Year 2027. TMDA, dated 28 July 2026, posted 1 October 2026. Accessed 2 Nov 2026.
• Tanzania Medicines and Medical Devices (Fees and Charges) Regulations, 2021, GN 686. Ministry of Health, published 24 September 2021. Accessed 2 Nov 2026.
• GN 686 of 2021 record. TanzLII, version of 24 September 2021. Accessed 2 Nov 2026.
• Fees and Charges (Amendment) Regulations, 2022, GN 5 of 2023. TanzLII, version of 6 January 2023. Accessed 2 Nov 2026.
• Fees and Charges (Amendment) Regulations, 2024 text. TMDA website, dated March 2024. Accessed 2 Nov 2026.
• Medical devices assessment fees and charges. TMDA, page read 2 November 2026. Accessed 2 Nov 2026.
• Fees and charges regulations. TMDA, page read 2 November 2026. Accessed 2 Nov 2026.
• Payment of Annual Retention Fees for the Year 2024. TMDA, 23 November 2023. Accessed 2 Nov 2026.
• Finance Act, 2019, No. 8 of 2019. Parliament of Tanzania, published by TRA, in force 1 July 2019. Accessed 2 Nov 2026.
• Tanzania Medicines and Medical Devices Act, Cap. 219 (unofficial consolidation). TanzaniaLaws, page dated 30 September 2023. Accessed 2 Nov 2026.
• Tanzania TMDA Sets 2027 Medical Device Retention Fee Dates. Pure Global, 27 October 2026. Accessed 2 Nov 2026.
• Tanzania shifts cosmetics regulation to standards bureau. News Central TV, 30 August 2019. Accessed 2 Nov 2026.
• ZFDA destroys 82 tonnes of unfit food product. Daily News, 30 June 2026. Accessed 2 Nov 2026.
• The Zanzibar Food, Drugs and Cosmetics Act, 2006. Policy Vault, version of January 2022. Accessed 2 Nov 2026.

Figures to confirm before you act

• The retention amount for each of your products. Check your TMDA proforma invoice against GN 686 of 2021, First Schedule, rows 6 (imported medicines), 26 and 27 (imported devices), 42 and 43 (imported diagnostics) and 58 (antiseptics and disinfectants).
• The notified device and notified diagnostic figure. GN 686 of 2021 and the March 2024 amendment text differ. Ask TMDA which schedule is in force.
• Whether TMDA will accept a product list submitted after 1 November 2026. The notice is silent.
• The content of GN 5 of 2023, which could not be read for this update.
• Section numbers of Cap. 219 on retention and cancellation, against the current revised edition.
• ZFDA's renewal fees and dates for Zanzibar registrations.

This article is general information based on official sources available at the date of publication. It is not legal, tax or financial advice. Laws and notices change. Verify with the issuing authority or consult Zatra before acting.