Clinical Evidence Mandatory for All Device Classes in Tanzania

1. Key takeaways

On clinical evidence, Tanzania gives the clearest single sentence among African markets. Part VII §3.1 of the 2024 Compendium of Guidelines states:

Submission of clinical evidence is mandatory for all devices regardless of their classification. Nevertheless, the extent and type of evidence submitted shall depend on the device under evaluation.

In other words: regardless of Class A/B/C/D, clinical evidence must be submitted in all cases; but the breadth and type of the evidence depend on the device under evaluation.

The definition of clinical evidence has two components:

• Clinical data: safety and/or performance information generated from the clinical use of a device, with sources including — a) the results of pre-market and post-market clinical investigations of the device; b) results of pre- or post-market clinical investigations or other studies reported in the scientific literature of a justifiably comparable device; c) published and/or unpublished reports of other clinical experience with the device or a justifiably comparable device.
• Clinical evaluation: the assessment and analysis of clinical data pertaining to a device, to verify the clinical safety and performance of the device when used as intended by the manufacturer. Its output is a report, which can be reviewed by conformity assessment bodies and regulatory authorities.

2. Legal basis

3. Expert insights

Insight 1: The obligation-holder is the manufacturer, not the applicant.

Part VII §3 is explicit: the obligation to collect and compile clinical evidence lies with the manufacturer, who provides this to the applicant. This is an important rule on the allocation of responsibility — an overseas manufacturer cannot push the compilation of clinical evidence onto the LRP or a distributor. The applicant remains responsible for submission logistics, but the substance of the evidence, its completeness and its scientific quality are manufacturer duties that cannot be delegated downstream.

Insight 2: Clinical evaluation is a continuous process, not a one-time document.

Part VII §2.3: clinical evaluation is a process carried out by the manufacturer to help establish conformity with the relevant essential principles; after the device is placed on the market, the manufacturer should routinely monitor clinical safety and performance information (adverse event reporting, results of further clinical investigations, published literature, among others) and re-assess the benefit and risk accordingly. The NOTE under §3 further emphasises that clinical evidence is required to be available throughout the lifecycle of a device, must be submitted with the marketing authorization application, and forms part of the post-market surveillance report.

Insight 3: The clinical evaluation must cross-reference the risk management documents.

§2.3 states expressly that one of the key aims of clinical evaluation is to demonstrate that any risks associated with the use of the device are acceptable when weighed against the benefits to the patient, and that the clinical evaluation will, therefore, also need to cross-reference risk management documents. This closes the loop with the ISO 14971 risk assessment required by regulation 11(d) of GN 315 — the risk documents and the clinical evaluation report must be mutually traceable, with each hazard addressed in both directions.

Insight 4: The evidentiary weighting migrates with market age — this is the part to be recalculated at renewal.

The NOTE under §3 observes that when the device has been on the market for a number of years, the relevance of comparable device data is less significant, and direct clinical experience data is likely to be of greater relevance. This means that at renewal (every 5 years), the evidence weighting structure of the clinical evaluation report should already have shifted — away from reliance on comparable-device literature, and toward the manufacturer’s own clinical experience data accumulated from post-market sources.

Insight 5: IVDs do not follow this guideline; they follow an independent clinical performance route.

Part VII §1 is explicit: this guideline is not applicable for in-vitro diagnostic devices. The clinical evidence requirements for IVDs are found in the Guidelines for Conducting Performance Evaluation of In-Vitro Diagnostic Devices Submitted for Marketing Authorization (June 2024) and the disease-specific laboratory performance evaluation protocols (2025). GRZAN notes that Tanzania runs IVD clinical performance and non-IVD clinical evidence as two separate systems, which cannot be cited in place of each other.

4. Practical recommendations

1. Prepare a clinical evaluation report even for Class A — this is one of the largest differences from other markets, and the experience that Class A needs no clinical evidence does not apply here.
2. Structure the clinical evaluation report (CER) as a standalone document, with a cross-reference table linking it to the ISO 14971 risk management documents.
3. Establish a post-market clinical information collection mechanism, accumulating the manufacturer’s own clinical experience data for the renewal in 5 years and for PMS reports.
4. Run IVDs through the performance evaluation route separately, drawing on the corresponding disease-specific laboratory evaluation protocols (the 6 protocols published in 2025).
5. Write out the justification for the comparable device — §2.2(b) uses the phrase justifiably comparable, so the reasons why the devices are comparable must be documented.

5. Verification checklist

• □ Confirmed that all classes (including Class A) must submit clinical evidence (Part VII §3.1).
• □ Clinical evidence = clinical data + a clinical evaluation report (CER), both in place.
• □ The CER cross-references the risk management documents (ISO 14971).
• □ The justification that the comparable device is justifiably comparable documented.
• □ Post-market clinical information collection mechanism established (for renewal and PMS reports).
• □ IVDs handled through the performance evaluation route, not through the non-IVD clinical evidence guideline.

Regulatory information verified as of 29 October 2026. All provisions cited in this document were checked against the official published texts of TMDA (the June 2024 Compendium of Guidelines, Part VII §1–§3.2; GN. No. 315, regulation 11), and will be re-checked when the regulations are updated.

• Tanzania local resources: licensed Local Responsible Person (LRP) and distributor resources can be coordinated to cover online submission, sample delivery, quality audit cooperation and port clearance.
• Service capabilities: classification determination, registration and notification pathway selection, technical documentation (CSDT/STED) preparation and localization, GMDN and grouping strategy, clinical evidence organization, software and AI device submissions, change management, vigilance and PMS reporting, annual retention fees and renewal management.
• Contact: hito.lin@grzan.cn; website www.grzan.cn.