Common Rejection Causes for Medical Device Applications in Tanzania

1. Key takeaways

The statutory refusal grounds in Tanzania are set out in Article 15 of GN 315, in two groups. They distinguish a formal refusal on substantive or conduct grounds from the procedural returns that occur far more often in day-to-day processing, and each carries different consequences for fees and timelines.

Article 15(1) — four grounds (a–d) on which the TMDA may refuse to issue or vary a registration:

• (a) the applicant fails to comply with any provision of the Regulations or the Act relating to medical devices;
• (b) a false or misleading statement is made in the application;
• (c) the device does not comply with the labelling requirements of the Regulations;
• (d) the applicant fails to furnish, by a date requested, any information or samples required under the Regulations.

Article 15(2) — the safety and performance catch-all: the device may also be refused if it does not meet the safety and performance requirements, or if the information or samples submitted are insufficient for the TMDA to determine whether the device meets those requirements.

Beyond refusal there are two more common categories of procedural return: Compendium Part I §3.4.2 provides that incomplete applications will be queried and returned for correction, and that applications on the notification pathway that do not qualify will be rejected and returned. §4 provides that samples are submitted after payment, and an application without samples does not enter the assessment process.

Where an application is refused, Article 15(3) requires the TMDA to notify the reasons in writing and to give the applicant an opportunity to be heard.

2. Legal basis

3. Expert insights

Insight 1: two of the four statutory grounds are purely procedural and entirely avoidable.

Article 15(1)(c) (labelling non-compliance) and (d) (failure to respond on time) do not concern the technical merit of the product at all, only the completeness of the dossier and compliance details. Project reviews single these out as zero-cost avoidable items: the label is compared item by item against the 11 items of Article 74(1)(a)–(k), and every query is tracked on an internal countdown against the 60 working days limit of §3.4.6. Refusals on these grounds represent failures of process discipline rather than of product quality, which makes them the cheapest failures to eliminate.

Insight 2: Article 15(2) is the true catch-all, and the burden of proof sits with the applicant.

The formulation — information or samples insufficient for the TMDA to determine compliance — does not require the dossier to look complete; it requires the dossier to be sufficient to support the conclusions. A dossier that stacks documents without an argument chain (for example, test reports with no mapping against the Essential Principles) will fail on this provision even though every individual document is present. Building the evidence mapping into the dossier structure before submission is the only reliable defence.

Insight 3: missing samples is not a refusal — the application simply never enters assessment.

§4: sample submission is a requirement for marketing authorisation, and all samples should be submitted after payment of the application fee; an application without samples shall not enter the assessment process. The difference from Article 15(1)(d) lies in timing — the former blocks at the entrance (after payment, before scheduling), the latter blocks at the correction stage. Many projects leave sample shipment to the end, effectively pushing the entire schedule (Class A/B ≤10, Class C/D ≤20 working days) backwards. Treating sample receipt confirmation as a scheduling trigger is the structural fix.

Insight 4: the consequence of choosing the wrong pathway is rejection and return, not correction.

The final sentence of §3.4.2: a notification application made for a product that does not qualify for notification will be rejected and returned. This is a different treatment from the return of incomplete applications — it means a wrong pathway determination requires a fresh registration submission and a new fee (fees are not refunded). The pathway determination should therefore be documented and independently checked before payment, since the cost of a wrong choice is the entire notification fee plus the delay of a full registration cycle.

Insight 5: refusal carries procedural remedies, but the remedy deadlines run on their own clock.

Article 15(3) guarantees written reasons plus an opportunity to be heard; dissatisfaction with the decision can be pursued by a written appeal to the Minister under Article 78, filed within 60 days. The combined practical meaning: after receiving a refusal letter, first complete the representation at the TMDA level, and assess an appeal in parallel — because the 60-day clock runs independently of the representation process. Waiting for the outcome of the representation before considering an appeal can consume most of the window.

4. Practical recommendations

1. Build an item-by-item checklist of the 11 labelling items (Article 74(1)(a)–(k)), complete one manual comparison before submission, covering the outer packaging and the instructions for use.
2. Ship the samples immediately after payment, and make internal sample receipt confirmation a precondition for starting the schedule.
3. Run a 60 working day countdown on every query, and escalate if there is no reply by the 45th working day — the application is deemed withdrawn on expiry.
4. Re-check the pathway determination before submission: whether a Class A device matches any of active, measuring or sterile, to avoid a rejection and return.
5. Exercise the opportunity to be heard first after a refusal letter, while assessing the Article 78 appeal timetable in parallel.

5. Verification checklist

• □ The 11 labelling items (Article 74(1)(a)–(k)) have been checked one by one, covering the outer packaging and the instructions for use.
• □ Samples were shipped after payment, and receipt records were obtained.
• □ Query responses are under 60 working days countdown management.
• □ The pathway determination (registration vs notification) has been re-checked, excluding the rejection-and-return risk.
• □ It has been confirmed that the application contains no false or misleading statement (Article 15(1)(b)).
• □ The opportunity to be heard after refusal and the 60-day appeal deadline are known.

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, 74 and 78; June 2024 Compendium, Part I §3.4.2, §3.4.6 and §4; change guidelines §4); the review is repeated whenever the regulations are updated.

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