Suspension and Cancellation of Registration in Tanzania

1. Key takeaways

Suspension and cancellation of device registration in Tanzania are governed by GN 315, Articles 18–21. Article 18 lists 9 grounds; where TMDA has reasonable grounds to believe that any of them exists, it may suspend or cancel the registration:

a) the registration contravenes any provision of the Regulations or of the Act relating to devices;

b) the registrant made a false or misleading statement in the application;

c) the registrant has failed to comply with the terms and conditions of the registration;

d) the registrant failed to submit information or samples by the specified date required under Article 16, or the information or samples provided were insufficient for TMDA to determine whether the device meets safety and effectiveness requirements;

e) the device no longer complies with safety and effectiveness requirements;

f) based on information obtained after registration, the QMS and GMP on which the design of Class C and Class D devices, or the manufacture, assembly, processing, packing, refurbishment or modification of Class B, C and D devices, is based are insufficient to ensure that the devices conform to their specifications;

g) the registrant failed to pay the prescribed retention fee within the prescribed time;

h) the registrant failed to submit PMS reports as required;

i) the registrant wilfully and without reasonable cause failed to submit adverse effect reports.

Procedurally, two paths exist: Article 20 (notice and hearing required first) and Article 21 (possible without a hearing). The distinction matters operationally, because the first path gives the registrant structured opportunities to remedy and to be heard, while the second can remove a product from the market at short notice where health protection demands it.

2. Legal basis

3. Expert insights

Insight 1: Four of the nine grounds in Article 18 are purely administrative omissions.

Ground (g) unpaid retention fees, ground (h) missing PMS reports, ground (i) wilful non-reporting of adverse effects, together with ground (d) failure to submit information or samples on time, have nothing to do with product quality. GRZAN lists these four as the highest-priority items of its annual compliance review, because they are entirely avoidable through register management, yet once they occur they directly threaten the validity of the certificate.

Insight 2: Article 20 grants a triple procedural protection, and the sequence cannot be inverted.

Under Article 20, TMDA may not suspend or cancel a registration until three conditions are met: (a) a written notice has been issued to the registrant stating the grounds for the proposed suspension, any corrective measures required and the period within which they must be completed; (b) the corrective period stated in the notice (if any) has expired without action; and (c) the registrant has been given an opportunity to be heard on the suspension. This is a complete notice–remedy–hearing chain, and each step generates documents the registrant should preserve.

Insight 3: Article 21 is the emergency exception, but it still leaves two remedies.

Article 21(1) allows TMDA, where necessary to prevent injury to the health or safety of patients, users or other persons, to cancel or suspend a registration without an opportunity for a hearing, but it must issue the registrant a written notice stating the grounds. Article 21(2) allows the registrant to request a reconsideration in writing. Article 21(3) requires TMDA to give the registrant an opportunity to be heard within 60 days of receiving the request, so the emergency route is fast but not final.

Insight 4: Article 18(f) elevates system failures to product failures, and it is broken down by stage.

The wording of Article 18(f) is specific: the QMS and GMP on which the design of Class C and D devices, or the manufacture, assembly, processing, packing, refurbishment or modification of Class B, C and D devices, is based must be sufficient to ensure conformity with specifications. Note that refurbishment and modification appear expressly in the list – this echoes the rule in Part IV §3.2.3 that third-party refurbishers bear manufacturer responsibilities, and it means outsourced post-market services fall within the scope of the registration risk.

Insight 5: Article 19 provides a voluntary exit channel, and Article 22 an expert consultation mechanism.

Article 19 allows TMDA, at the request and application of the registrant, to cancel the registration of a device (voluntary cancellation). Article 22(1) allows the Director General to establish an expert committee to advise on specific questions of device registration, and Article 22(2) provides that the committee acts within terms of reference set by the Director General. This is a procedural resource in disputes over technical questions, and it can be requested before positions harden.

4. Practical recommendations

1. Make the four administrative grounds (d), (g), (h) and (i) mandatory items of the annual compliance red line.
2. Remediate immediately upon receiving an Article 20 notice; once the stated period expires without action, the hearing and suspension process begins.
3. If an Article 21 suspension without notice occurs, request reconsideration in writing immediately, remembering that TMDA has 60 days to grant a hearing.
4. Bring refurbishment and modification activities within the QMS scope (Article 18(f)).
5. Use the voluntary exit under Article 19 rather than allowing a certificate to lapse naturally or fees to go unpaid.
6. In technical disputes, request that the Director General activate the Article 22 expert committee mechanism.

5. Verification checklist

• □ Self-check completed against the 9 grounds of Article 18, with priority on the four administrative grounds (d), (g), (h) and (i).
• □ Awareness of the notice–remedy–hearing triple protection of Article 20.
• □ Awareness of the emergency suspension without notice under Article 21 and of the remedy of a hearing within 60 days (Article 21(3)).
• □ Refurbishment and modification activities are included in the QMS and GMP scope (Article 18(f)).
• □ Awareness that voluntary exit follows the Article 19 cancellation procedure.
• □ Awareness that the Article 22 expert committee mechanism can be used as a procedural resource in technical disputes.

Regulatory information verified as of 29 October 2026. All provisions cited in this document were checked against the official texts published by TMDA (GN. No. 315, Article 16 and Articles 18–22; the June 2024 Compendium, Part I §5.1 and §5.2; TMDA public notice of 17 August 2026); the review is repeated whenever the regulations are updated.

• Tanzania local resources: GRZAN can coordinate licensed local responsible person (LRP) and distributor resources covering online submission, sample delivery, quality audit support and port release.
• Service capabilities: classification determination, registration and listing pathway selection, preparation and localisation of technical documentation (CSDT/STED), GMDN and grouping strategy, clinical evidence organisation, software and AI device submissions, change management, vigilance and PMS reporting, annual retention fee and renewal management.
• Contact: hito.lin@grzan.cn; website www.grzan.cn.