TMDA Logo and Official Statements Prohibited in Labelling

1. Key takeaways

Tanzania draws a clear red line on labelling. The 2024 Compendium of Guidelines for Marketing Authorization of Medical Devices, Diagnostics and Laboratory Equipment states in Part VIII §3.5 (Use of TMDA Logo):

Any logo of the TMDA is prohibited to be placed in the medical device labelling. Use of specific statements such as Tanzania Medicines and Medical Device Authority (TMDA) and/or Ministry of Health Tanzania (unless it required by Ministry of Health Tanzania) is prohibited in all labelling as it is considered as an endorsement from the Authority.

This translates into three prohibitions:

1. It is prohibited to place any TMDA logo on the device labelling;
2. It is prohibited to use the statement Tanzania Medicines and Medical Device Authority (TMDA) in all labelling;
3. It is prohibited to use the statement Ministry of Health Tanzania — unless the Ministry of Health Tanzania requires it.

The reason given by the authority is that such use is considered an endorsement from the regulator, which no applicant may claim through its commercial materials.

2. Legal basis

3. Expert insights

Insight one: the prohibition covers the whole territory of labelling, not only the outer packaging.

Section 3.5 uses the words in all labelling. Read with the definition in Part VIII §2, Labelling or information supplied by the manufacturer or product information covers written, printed or graphic materials attached to the device or any of its containers or packaging, or supplied with the device, relating to identification, technical description and use — but excluding shipping documents. The outer packaging, inner packaging, instructions for use, patient information leaflets and e-IFU pages therefore all fall inside the prohibition. Any one of these carriers breaches the rule.

Insight two: read together with Regulation 15(1)(c), the consequence is refusal of registration.

Regulation 15(1)(c) of GN 315 provides that where a device does not comply with the labelling requirements of these Regulations, TMDA may refuse to issue or amend the registration of the device. A TMDA logo on the label is therefore not merely a labelling correction; it constitutes a statutory ground for refusal, which makes this a submission-blocking issue rather than a cosmetic one.

Insight three: there is an instructive contrast with changes involving reference authority approval marks.

TMDA/DMD/MDA/G/003 §3.3(c) treats a labelling change consisting of the addition or removal of a reference authority approval (for example the CE mark) as a notification-type change — the company may add or remove the CE mark and report it afterwards. The TMDA logo and name, by contrast, are absolutely prohibited and fall outside the notification category altogether. The distinction is that the mark of another regulator is commercial information, while the mark of the domestic regulator would read as an endorsement.

Insight four: Regulation 73 adds a separate advertising-level restriction on comparisons.

Regulation 73(1) prohibits the comparison of devices for competition purposes. Regulation 73(2) provides that comparisons of devices shall not be disparaging and must be factual, fair and representative of the totality of the evidence, and must not mislead by distortion, undue emphasis or in any other way. The provision points in the same direction as §3.5: Tanzania does not want the name of the regulator, nor disparaging comparisons, in market communications.

Insight five: the only exception is a requirement of the Ministry of Health.

The parenthesis in §3.5 leaves one opening: unless it required by Ministry of Health Tanzania. Such situations typically arise where a government programme or public health initiative designates specific products. Where this applies, the company must retain the written request from the Ministry of Health as documentary support, so that any audit or inspection can trace the authority for the use.

4. Practical recommendations

1. Add a mandatory check to the labelling design specification: no TMDA logo, no TMDA statement, no Ministry of Health Tanzania statement.
2. Sweep every carrier: outer packaging, inner packaging, IFU, patient information leaflet, e-IFU web pages, and promotional datasheets.
3. Where use is genuinely required by a Ministry of Health programme, obtain and retain the written request.
4. Do not use TMDA-registered as an advertising slogan; registration status may be stated factually, but the authority’s logo or name must not appear in an endorsement form.
5. Check advertising materials at the same time: Regulation 68 prohibits the promotion of unregistered devices, and Regulation 73 prohibits comparisons for competition purposes.

5. Verification checklist

• □ No TMDA logo appears in the labelling or any accompanying materials.
• □ The statement Tanzania Medicines and Medical Device Authority (TMDA) does not appear in the labelling.
• □ The statement Ministry of Health Tanzania does not appear (unless a written Ministry requirement exists).
• □ All carriers have been checked: outer packaging, inner packaging, IFU, patient information leaflet, e-IFU, datasheets.
• □ It is understood that a labelling breach is a ground for refusal under Regulation 15(1)(c).
• □ Advertising materials have been checked in parallel (Regulations 68 and 73).

Regulatory information verified as of 29 October 2026. All provisions cited in this document were checked against the official TMDA published texts (the June 2024 Compendium Part VIII §2 and §3.5; GN. No. 315, Regulations 15(1)(c), 68 and 73) and will be re-reviewed when the regulations are updated.

• Local resources in Tanzania: GRZAN can coordinate a licensed Local Responsible Person (LRP) and distributor resources, covering online submission, sample delivery, quality audit support, and port clearance.
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