Borderline Products: Classification Under TMDA Part XI Guidance

1. Key takeaways

When a product shows the features of both a device and a medicine (or a cosmetic, a food supplement or a biocidal product), Tanzania provides a dedicated determination tool. Section 3.4.1 of Part I of the 2024 Compendium states:

In some cases, it may be difficult to determine whether a product is a medical device particularly when the product has features similar to medicines, cosmetics, food supplements or biocidal. Furthermore, when a product consists of two or more regulated components (a medical device and a medicine) that are combined/integrated as a single product or co-packed and sold together, applicants may face challenges in understanding if the product should attain authorization as a medical device or medicine.

Such products are referred to as borderline products. For guidance on how to determine if a borderline product is a medical device refer to Guidelines on Borderline Products found under part XI of this compendium.

Part XI of the Compendium, the Guidelines on Borderline Products (pages 196–201), provides the determination process, including a flowchart for determining if a product fulfils the definition of a medical device.

2. Legal basis

3. Expert insights

Insight 1: the authority splits borderline questions into two categories, and only the first has a determination process in Part XI.

The description in Part I §3.4.1 covers two situations: first, a product whose features are similar to medicines, cosmetics, food supplements or biocidal products; second, a product consisting of two or more regulated components (a device plus a medicine) that are combined or integrated as a single product, or co-packed and sold together. Part XI provides the determination process for whether a product meets the device definition — that is, it resolves the first category and supplies the classification foundation for the second. Companies facing combination scenarios should document both steps separately, because the regulatory departments and fee structures differ once a product crosses the boundary.

Insight 2: a wrong classification makes everything downstream wrong — Article 68(2) and the fee structure are both affected.

Article 68(2) prohibits advertising a non-device product as a device. The fee structure also differs (devices fall under the TMDA medical devices assessment division, medicines under the medicines registration division). The working approach is: run the Part XI flowchart during product development and archive the conclusion, rather than waiting to be challenged after submission. A determination made after submission locks the company into whichever pathway was chosen, and correcting it mid-review can mean losing the assessment position and the fee already paid.

Insight 3: drug-combination devices carry two dedicated prohibited-change provisions at the change stage.

TMDA/DMD/MDA/G/003 §4(f): a change to the active pharmaceutical ingredient combined with a registered device requires a new application; §4(g): a change to a registrable medicine playing a secondary role in the device requires a new application. These two provisions show that Tanzania guards the device–medicine boundary tightly: once the pharmaceutical component changes, the classification of the product changes with it. Change management systems for combination products should therefore route any pharmaceutical-component modification directly to the new-application track rather than through the routine change workflow.

Insight 4: the division of labour between Part XI and Parts V/VI is classification first, then category.

Part XI answers whether a product is a device (classification); Part V (non-IVD devices) and Part VI (IVDs) answer which risk category it belongs to (categorisation). The order cannot be reversed — many companies jump straight to categorisation and are returned at the classification stage. Building the sequence into internal submission checklists prevents this recurring failure, which is one of the most common avoidable delays observed in practice.

Insight 5: compared with ordinary devices, borderline products carry one extra pre-submission step.

Part I §3.4.1 requires five items to be ready before submission: category, intended purpose, GMDN code, conformity assessment certificate and declaration of conformity. For a borderline product, the first item — the category — itself depends on the Part XI conclusion, so the determination process is a pre-condition to submission rather than a parallel task. Scheduling the determination early also gives time to prepare the reasoning record that reviewers may request when the product sits near the boundary.

4. Practical recommendations

1. Run the Part XI flowchart at the product development stage and archive the determination process and conclusion.
2. Follow the order of classification first, then category; do not skip classification and jump to categorisation.
3. For drug- or biological-product combinations, manage pharmaceutical component changes separately (§4(f) and §4(g)).
4. The classification conclusion affects advertising compliance (Article 68(2)) and the receiving division; synchronise it across external materials.
5. Assess co-packed products separately — two regulated components sold together are expressly listed by the authority as a borderline scenario.

5. Verification checklist

• □ The Part XI determination flowchart has been completed and the conclusion archived.
• □ The order of classification first, then category, has been followed (Part XI, then Part V/VI).
• □ For drug-combination devices, pharmaceutical component change management has been handled separately (§4(f)(g)).
• □ Co-packed products have been assessed separately (Part I §3.4.1).
• □ The classification conclusion has been synchronised to advertising and external materials (Article 68(2)).
• □ Among the five pre-submission items, the category is supported by a Part XI conclusion.

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 (June 2024 Compendium, Part I §3.4.1 and Part XI; GN. No. 315, Articles 3 and 68(2); TMDA/DMD/MDA/G/003 §4(f)(g)); the review is repeated whenever the regulations are updated.

• Tanzania local resources: GRZAN can coordinate licensed local responsible persons (LRP) and distributor resources covering online submission, sample delivery, quality audit support and port clearance.
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