Appeals to the Minister: Challenging TMDA Decisions in Tanzania
Updated: 2026-11-12 · GRZAN Regulatory Team · Verification date 2026-10-20
1. Key takeaways
Tanzania splits the remedies available against a TMDA decision into two distinct tracks: an internal reconsideration request directed to TMDA itself, and a formal appeal to the Minister. Each track carries its own statutory deadline, and the consequences of missing those deadlines are permanent. Understanding which track applies to which kind of adverse decision is the first practical step for any licence holder or applicant.
Article 78 of GN 315 (appeal to the Minister):
- Article 78(1): a person aggrieved by a decision of the TMDA may, within 60 days, appeal to the Minister in writing.
- Article 78(2): notwithstanding that provision, a person who has not filed an appeal within the prescribed period may, within 30 days, apply to the Minister for an extension of time; (a) the Minister may extend the appeal period for any good cause; (b) if no appeal is filed within the extended period, the person shall be barred from appealing.
- Article 78(3): in determining an appeal the Minister may — (a) constitute a panel of experts to advise on the subject of the appeal; (b) allow or dismiss the appeal; (c) revoke any refusal, cancellation or suspension decision; (d) order a person to make a fresh application.
Article 21 (internal reconsideration): against a suspension or cancellation imposed without prior notice under Article 21(1), the registrant may request the TMDA in writing to reconsider the decision; the TMDA shall give the registrant an opportunity to be heard within 60 days of receiving the request (Article 21(3)).
2. Legal basis
| Regulation | Number | Publication date | Provisions |
|---|---|---|---|
| The Tanzania Food, Drugs and Cosmetics (Control of Medical Devices) Regulations, 2015 | GN. No. 315 | 31 July 2015 | Articles 15(3), 21(2), 21(3), 22(1), 22(2), 34(2), 37, 38, 78(1), 78(2), 78(3) |
3. Expert insights
Insight 1: the appeal lies to the Minister, not to a court and not within TMDA.
Article 78(1) expressly names the Minister as the recipient of the appeal. This is an administrative remedy, and it sits at a different level from the reconsideration requests available under Article 21(2) (suspension or cancellation without notice) and Article 37 (reconsideration of premises licence decisions). When an adverse decision arrives, the company must first determine which of these provisions actually governs its situation. Filing the request under the wrong provision wastes weeks of a limited window, and the regulator is under no obligation to redirect a misfiled remedy to the correct track before the deadline expires.
Insight 2: the loss of the right to appeal is written into Article 78(2)(b), and the wording is barred.
An appellant who fails to file even within the extended period is barred from appealing — a final, closed formulation. The two numbers therefore have to be managed strictly: 60 days is the appeal period, and 30 days is the window for requesting an extension. Taken together they give at most 90 days from the decision, after which the door closes permanently. There is no third opportunity, and the wording leaves the Minister no discretion to revive a lapsed appeal once the extended period has run. Compliance teams should treat these dates with the same discipline they apply to payment deadlines.
Insight 3: the Minister’s powers on appeal are broad, including ordering a fresh application.
Article 78(3) gives the Minister four options: constituting an expert panel, allowing or dismissing the appeal, revoking a refusal, cancellation or suspension decision, and ordering a fresh application. Option (d) — to order a person to make a fresh application — means that even a successful appeal may not end with a certificate being issued directly. The company can be required to repeat the application process from the beginning. Budget planning for an appeal should therefore account for the possibility that fees, documentation and review time will be incurred a second time.
Insight 4: the opportunity to be heard recurs across procedures and is a consistent procedural safeguard.
Article 15(3) (refusal of registration must state reasons and give an opportunity to be heard), Article 20(c) (suspension or cancellation of registration requires a hearing opportunity), Article 34(2) (refusal of a premises licence must state reasons and give a hearing opportunity), Article 36(3)(c) (suspension of a premises licence requires a hearing opportunity) and Article 21(3) (an opportunity to be heard within 60 days after a suspension without notice) together show that Tanzania has built a hearing stage in front of virtually every adverse decision. These are procedural rights the company should actively invoke rather than wait for; in practice the regulator does not always schedule the hearing on its own initiative.
Insight 5: the expert panel mechanism appears twice, at different levels.
Article 22(1) allows the Director General to constitute a panel of experts to advise on specific questions of device registration (registration stage); Article 78(3)(a) allows the Minister to constitute a panel of experts on the subject of an appeal (appeal stage). Both are usable resources for resolving technical disputes, and a company facing a contested scientific or performance question should evaluate both routes rather than treat the appeal as purely legal argument.
4. Practical recommendations
- Open a deadline log on the day the adverse decision is received: the 60-day appeal period and the 30-day extension application window.
- Separate the tracks first: a suspension without notice goes to TMDA for reconsideration under Article 21(2); other adverse decisions go to the Minister under Article 78.
- Proactively request a hearing — Articles 15(3), 20(c), 34(2) and 36(3)(c) all confer this right.
- In the appeal, invoke the revocation power of Article 78(3)(c) rather than merely asking for reconsideration.
- For technical disputes, request the constitution of an expert panel (Article 22 or Article 78(3)(a)).
- Never miss the deadline: the barred consequence of Article 78(2)(b) is final.
5. Verification checklist
- □ Appeal deadlines recorded: 60 days (Article 78(1)) and a 30-day extension application window (Article 78(2)).
- □ Tracks separated: suspension without notice goes to Article 21(2) reconsideration; other decisions go to the Article 78 appeal.
- □ A hearing opportunity has been actively requested in every adverse decision.
- □ The appeal invokes the revocation power of Article 78(3)(c).
- □ The option of an expert panel (Article 22 / Article 78(3)(a)) has been assessed for technical disputes.
- □ The consequence of missing the deadline — barred under Article 78(2)(b) — is known to the team.
Regulatory information verified as of 29 October 2026. All provisions cited in this document have been checked against the official published text of the TMDA (GN. No. 315, Articles 15(3), 20, 21(2)(3), 22, 34(2), 36(3), 37, 38, 78); the review is repeated whenever the regulations are updated.
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Disclaimer
Prepared by GRZAN from publicly available regulation. It is provided for general information only and does not constitute legal advice. Legislation and official fees are subject to change by the competent authority.
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