Labelling Content and Language Rules for Medical Devices in Tanzania

1. Key takeaways

Tanzania operates a two-layer labelling regime: statute and guidance. The statute fixes the mandatory content and the language options; the 2024 Compendium then tightens the language rule for home-use devices and adds a longer design checklist.

Statute (Regulation 74 of GN 315) — no person may import or sell a device that does not bear the following information, eleven items in total:

(a) the name of the device; (b) the name and address of the manufacturer; (c) the device identifier, including identification as part of a system, test kit, device group, device family, or device family group; (d) the lot or batch number; (e) where the contents are not readily identifiable, an appropriate indication of the contents of the packaging (size, net weight, length, volume, or number of units); (f) where the manufacturer intends the device to be sold sterile, the statement Sterile; (g) where the device is intended for single use, the statement for single use only; (h) the expiry date, expressed as month and year; (i) unless evident to the intended user, the medical condition, purpose and uses for which the device is manufactured, sold or represented, including the performance specifications necessary for proper use; (j) instructions for use; (k) any special storage conditions applicable.

Language (Regulation 75): the information required by Regulation 74 must be given in English or Kiswahili, or in both English and Kiswahili.

Guidance (2024 Compendium, Part VIII §3.4) goes further:

The language to be used for labels and instructions for use for products intended to be marketed in Tanzania should be in English and/or Kiswahili, moreover the following shall be considered: a) The use of Kiswahili shall be required for home use medical devices; and b) Other languages may be used as necessary.

In short: Kiswahili is mandatory for home-use devices.

2. Legal basis

3. Expert insights

Insight one: the statute says English or Kiswahili; the guidance upgrades home-use devices to Kiswahili as a must.

Regulation 75 sets a three-way choice (English, Kiswahili, or both). Part VIII §3.4(a) then adds a mandatory element for home-use devices. The practical reading is that home-use devices must carry Kiswahili at minimum, while professional-use devices may be labelled in English only, although adding Kiswahili is the safer option across the portfolio.

Insight two: Regulations 74(3)–(5) solve the packaging-too-small problem, but the order of the rules cannot be reversed.

Regulation 74(3): where a device is to be sold to the public, the information required by Regulation 74(1) must be placed on the outside of the packaging and be visible under normal conditions of sale. Regulation 74(4): where the packaging is too small to display all the required information, the instructions for use must accompany the device, but need not be placed on the outside of the packaging or be visible under normal conditions of sale. Regulation 74(5): even so, the accompanying information must be provided in the form of a package insert, manual, leaflet, or any other manner. Outer-packaging visibility is the principle, accompaniment is the exception, and the exception still requires a physical carrier.

Insight three: the Part VIII §5.1 label checklist is longer than Regulation 74, with twenty items, several of which are easily missed.

Section 5.1 lists items (a) to (t), and a few deserve separate attention:

• (e) where appropriate, an indication that the device contains or incorporates a medicinal or biological substance (for example a heparin-coated catheter);
• (f) the lot or serial number, prefixed with the words LOT or SERIAL NUMBER or an equivalent symbol, to enable post-market action where traceability or recall is required;
• (g) a clear indication of the manufacturing and expiry dates, expressed at least as year and month, with the format following ISO 8601;
• (s) where the device is refurbished, an indication of that fact, together with the date of refurbishment;
• (t) devices for veterinary use must be marked For Veterinary Use or Device for Veterinary Uses Only.

Insight four: the placement of Kiswahili translations may be decided by risk assessment, but the assessment must be submitted at registration.

Part VIII §3.3(e) provides that information to be translated into Kiswahili should be placed next to the English version; alternatively, the position of the translation may be determined by a risk assessment, and that risk assessment must be submitted at the time of registration. This gives design flexibility but places the burden of proof on the applicant: the assessment document must travel with the application file.

Insight five: symbols must conform to ISO 15223, and explanations are owed where symbol meaning is not evident.

Part VIII §1 requires symbols used on labels of devices, IVDs and laboratory equipment to meet the minimum requirements of the current ISO 15223 (ISO 15223-1), with examples in Annex III of the Compendium. The later part of §3.3 encourages the use of internationally recognized symbols provided that device safety is not compromised by a patient or user failing to understand them; where the meaning of a symbol is not evident to the user (for example on home-use devices or newly introduced symbols), an explanation must be provided. Combined with §3.4(a), a home-use device effectively has to satisfy both Kiswahili language and symbol explanation duties at once.

4. Practical recommendations

1. Run the eleven-item self-check under Regulation 74 first, then complete the design against the twenty items of Part VIII §5.1 — the statute is the floor and the guidance is the full checklist.
2. Localize home-use devices into Kiswahili and pair every non-intuitive symbol with an explanation.
3. Unify date formats on ISO 8601, with expiry dates expressed at least to year and month (Regulation 74(1)(h)).
4. Do not miss the markings for refurbished and veterinary devices (§5.1(s) and (t)).
5. Where a risk assessment decides translation placement, file the assessment with the registration dossier.
6. Display on the outer packaging as the default; where the packaging is too small, use the accompaniment route and secure a carrier (Regulations 74(4) and (5)).

5. Verification checklist

• □ The label carries all eleven items of Regulation 74(1).
• □ Language complies with Regulation 75 (English, Kiswahili, or both); home-use devices carry Kiswahili (Part VIII §3.4(a)).
• □ Lot and serial numbers are prefixed with LOT or SERIAL NUMBER.
• □ Date formats follow ISO 8601, with expiry dates given at least to year and month.
• □ Refurbished devices are marked with the refurbishment date; veterinary devices carry the For Veterinary Use statement.
• □ Symbols conform to ISO 15223-1 and non-intuitive symbols carry explanations.
• □ Where translation placement rests on a risk assessment, the assessment has been submitted with the application.
• □ Outer-packaging visibility is met; where packaging is too small, an accompanying carrier is provided.

Regulatory information verified as of 29 October 2026. All provisions cited in this document were checked against the official TMDA published texts (GN. No. 315, Regulations 74 and 75; the June 2024 Compendium Part VIII §1, §3.3, §3.4, §5.1 and §5.2) 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.
• Service capabilities: classification determination, route selection between registration and notification, technical documentation (CSDT/STED) preparation and localization, GMDN coding and grouping strategy, clinical evidence organization, software and AI-enabled device submissions, change management, vigilance and PMS reporting, and annual retention fee and renewal management.
• Contact GRZAN for registration documentation and conformity support for the Tanzania market: info@grzanglobal.com.