Donated Devices, Free Samples and Research Devices in Tanzania

1. Key takeaways

Tanzania sets dedicated rules for donated devices and free samples, and in neither case does the absence of a commercial transaction mean the absence of regulation. The core provisions of GN 315 are summarised below.

Three practical themes emerge from this table. Donations must clear both the general registration requirement and a documentary gate consisting of a letter on official letterhead and a Donation Certificate. Free samples are tightly bounded by a label requirement and a numeric cap measured in unit packs. And even genuinely free devices generate regulatory fees, because they are charged on FOB value under the Fees and Charge Regulations, so budgets for donation or sample programmes must include the regulatory cost line.

2. Legal basis

3. Expert insights

Insight 1: In the official PDF, the Part headings and the provision contents are offset by one; cite the provision content, not the heading.

In the official text of GN 315, within Part V (IMPORTATION AND EXPORTATION) the section headings are shifted by one position relative to the provisions: under the heading Conditions for donated medical devices sits Article 50 (no import of unregistered devices plus public interest approval); under the heading Restriction to Importation of free samples sits Article 51 (donated device requirements); under the heading Importation of free of charge medical devices sits Article 52 (prohibition on selling and labelling of free samples, and quantities); Article 53 is the provision on free of charge devices, and Article 54 covers devices for research.

GRZAN’s citation principle is to quote only the article number and the content of the provision, never the misaligned heading, and to note the phenomenon in external documents so that readers do not doubt the source.

Insight 2: The 300 unit packs cap in Article 52(2)(b) is a quantifiable hard limit.

The original text reads: “the quantity of the commercial pack shall not exceed 300 unit packs per single consignment”. Note that the unit is the unit pack, not the individual device and not the carton – the count is made at the level of the commercial pack. A free sample consignment above the cap is refused, so the shipping plan must be sized to the limit rather than adjusted afterwards.

Insight 3: Free does not mean free of charges.

Article 53(2) provides that “all free of charge medical devices shall be charged Free on Board as per Fees and Charge Regulations in force”. In other words, even devices supplied at no cost are charged on their FOB value under the current fee regulations. Article 53(1) additionally requires that an application to import free devices be accompanied by a proforma invoice showing the unit price of each product, so the valuation data must exist even for a no-cost shipment.

Insight 4: Import of devices for research presupposes an approved clinical trial.

Article 54(1) requires the application to import devices for research to be made by the clinical trial sponsor or principal investigator of a study already approved to be conducted in Tanzania, and Article 54(2) requires the application to be accompanied by a Clinical Trial Approval Letter issued by TMDA. The sequence is therefore fixed: obtain the clinical trial approval first, then apply to import the devices; an import application cannot precede or run in parallel with the trial approval.

Insight 5: Donated devices must pass two gates – Article 50 and Article 51.

Article 51(1) requires donated devices to comply with the Regulations, which includes the registration requirement; Article 51(2) requires the letter on official letterhead and the Donation Certificate. Where the donated device is unregistered, approval on public interest grounds must also be obtained under Article 50(2). All three documents – the letter, the Donation Certificate and the public interest approval – may therefore be required for a single donation, and each has its own lead time.

4. Practical recommendations

1. Prepare two documents early for donation projects: a letter on institutional letterhead plus the Donation Certificate (Article 51(2)).
2. For unregistered donated devices, additionally pursue the public interest approval of Article 50(2) on a case-by-case basis.
3. Self-check sample labelling and quantity first: the Free sample – Not for sale marking plus no more than 300 unit packs per consignment.
4. Budget the FOB-based charges for free devices; do not omit them from the budget (Article 53(2)).
5. Obtain the clinical trial approval letter before applying to import research devices (Article 54).
6. When citing the law, quote article numbers only and not the misaligned official headings.

5. Verification checklist

• □ For donated devices, the letter on official letterhead and the Donation Certificate are in place (Article 51(2)).
• □ Public interest approval under Article 50(2) has been obtained for unregistered donated devices.
• □ Free sample labels are printed with Free sample – Not for sale (Article 52(2)(a)).
• □ Commercial packs per consignment do not exceed 300 (Article 52(2)(b)).
• □ Free devices have been charged at FOB value and included in the budget (Article 53(2)).
• □ The TMDA Clinical Trial Approval Letter has been obtained for research devices (Article 54(2)).
• □ External citations use article numbers only and do not rely on the misaligned official headings.

Regulatory information verified as of 29 October 2026. All provisions cited in this document were checked against the official texts published by TMDA (GN. No. 315, Articles 50–54); the review is repeated whenever the regulations are updated.

• Tanzania local resources: GRZAN can coordinate licensed local responsible person (LRP) and distributor resources covering online submission, sample delivery, quality audit support and port release.
• Service capabilities: classification determination, registration and listing pathway selection, preparation and localisation of technical documentation (CSDT/STED), GMDN and grouping strategy, clinical evidence organisation, software and AI device submissions, change management, vigilance and PMS reporting, annual retention fee and renewal management.
• Contact: hito.lin@grzan.cn; website www.grzan.cn.