Advertisement and Comparison Rules for Medical Devices in Tanzania

1. Key takeaways

Tanzania imposes an independent statutory regime on the advertising of medical devices (GN 315, Articles 67–72), and within it two sets of provisions matter most in practice. The first set controls when a device may be promoted at all; the second set controls how one device may be compared with another. Both apply from the moment promotional material is drafted, not from the moment of sale.

Article 68(1): no device that has not been registered by the TMDA shall be promoted.

Article 68(2): if a product is not a device, no person shall advertise it or cause it to be advertised as a device.

Article 68(3): no person shall advertise or cause to be advertised a registered device except in accordance with the relevant provisions.

Article 73(1): comparison of medical devices for competition purposes is prohibited.

Article 73(2): a comparison of devices shall not be disparaging and must be factual, fair and reflect the body of evidence, and shall not mislead by distortion, by undue emphasis or in any other way.

2. Legal basis

3. Expert insights

Insight 1: Article 68(1) and Article 6 form a double lock — Article 6 governs the sale and Article 68 governs the message.

Article 6 prohibits selling, manufacturing, importing, exporting, distributing, donating or offering for sale an unregistered device; Article 68(1) prohibits promoting an unregistered device. The two provisions cover different conduct: one governs transactions, the other governs communication. Pre-registration market warm-up activities — trade fair displays, website product pages, distributor announcements — are therefore constrained by both provisions at once. A company that waits for the certificate before shipping but publishes promotional content in the meantime is in breach of the advertising provision even though no product has moved.

Insight 2: the prohibition in Article 73(1) covers comparison for competition purposes, not every comparison.

Article 73(1) prohibits comparison of medical devices for competition purposes. Article 73(2) then sets four standards for comparisons that are permitted: not disparaging, factual, fair and reflecting the body of evidence, without misleading by distortion, undue emphasis or any other means. The legal evaluation of an academic, non-competitive comparison (for example, a performance discussion in a literature review) differs from that of a comparison inside competitive advertising. Marketing teams should classify each piece of material by purpose before drafting, because the same factual content can be lawful in one context and prohibited in the other.

Insight 3: read Article 73 together with the logo prohibition in Part VIII §3.5 and the regulatory intent is clear.

Section 3.5 prohibits the use of the TMDA logo and name on labels, on the ground that this would be regarded as an endorsement from the authority; Article 73 prohibits disparaging comparisons made for competition purposes. Together the two provisions point in one direction: regulatory authority and unfair competitive methods must be kept out of the market communication of devices. Companies should treat any visual or textual element that could suggest official endorsement — certificates, seals, authority names — as a compliance flag requiring review before publication.

Insight 4: Article 68(2) targets a non-device product being passed off as a device.

If a product is not a device (for example, a borderline product determined to be a medicine, a cosmetic, a food supplement or a biocidal product), it must not be advertised as a device. This links directly to Part XI of the 2024 Compendium (borderline product determination) — if the product is misclassified, the advertising itself becomes unlawful (see the dedicated article in this series). The consequence is not merely a marketing error: advertising a misclassified product can trigger regulatory action against the whole portfolio of the advertiser.

Insight 5: the official PDF shows the same heading and text misalignment in Part VIII.

As with Part V, the article headings in Part VIII of the official text are misaligned with the text itself: the table of contents lists restriction on advertisement as Article 67 and labelling as Article 73, whereas in the body text Article 68 is restriction on advertisement, Article 73 is Comparison of Products, Article 74 carries the eleven labelling items and Article 75 the language requirement. The citation principle applied here is to follow the body text of the provision. Citing the misaligned table-of-contents headings in formal submissions or appeal documents creates avoidable confusion and should be avoided.

4. Practical recommendations

1. Do not conduct any promotion before the registration certificate is issued, including trade fairs, website product pages and distributor publicity (Article 68(1)).
2. Review every comparison in advertising material against the four standards of Article 73(2): not disparaging, factual, fair, reflecting the body of evidence.
3. Do not make comparisons for competition purposes (Article 73(1)).
4. Do not use the TMDA logo or name in advertising (Part VIII §3.5).
5. Determine the classification of borderline products before promotion (Article 68(2) plus Part XI).
6. Cite the body text of provisions, not the misaligned table-of-contents headings.

5. Verification checklist

• □ It has been confirmed that the device is registered before any promotion (Article 68(1)).
• □ Comparisons in advertising have been reviewed against the four standards of Article 73(2).
• □ No comparison for competition purposes has been made (Article 73(1)).
• □ No TMDA logo or name appears in advertising material (Part VIII §3.5).
• □ Borderline products have completed classification (Part XI) before promotion (Article 68(2)).
• □ Provisions are cited from the body text, not from misaligned headings.

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 68 and 73; the June 2024 Compendium, Part VIII §3.5 and Part XI); 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.
• 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 fee and renewal management.
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