Import and Export Permit Requirements in Tanzania

1. Key takeaways

Tanzania operates a permit-per-shipment system for the import and export of medical devices. There is no annual or blanket authorization that covers a trading programme: every consignment needs its own permit issued by the Tanzania Medicines and Medical Devices Authority (TMDA). GN 315, Articles 45–47, forms the backbone of this regime, and the core rules can be summarised as follows.

Two consequences follow directly from this table. First, procurement planning must be translated into individual permit applications per batch, because a permit that expires or that is attached to the wrong consignment offers no protection at the border. Second, the asymmetry between the 6-month validity of import permits and the 3-month validity of export permits means that companies using Tanzania as a regional distribution hub must run two separate validity calendars. Article 50(1) adds a second lock: no device may be imported unless it has been registered by TMDA, although Article 50(2) allows unregistered devices to be approved on public interest grounds on a case-by-case basis. Article 55 finally gives TMDA the discretion to revoke, cancel or suspend permits where the importer, exporter or the goods breach any provision of the Regulations.

2. Legal basis

3. Expert insights

Insight 1: 6 months versus 3 months – the validity periods are asymmetric, and the export window is tighter.

Article 47(3) fixes the validity of import permits at 6 months and export permits at 3 months, counted from the date of issue. Companies doing regional distribution, with Tanzania serving as an East African transshipment hub, must schedule the export side separately. An export permit that is planned on the rhythm of the import side will routinely expire before the outbound shipment is ready, and an expired permit is treated the same way as no permit at all.

Insight 2: One permit per batch plus non-transferability means the permit, bill of lading and invoice must correspond exactly.

Under Article 47(4) a permit covers a single batch and may not be transferred to any other importer or exporter. This rules out the practice of clearing goods through customs using a permit held by a different company. GRZAN advises that when the local responsible person (LRP) or the distributor changes, permits covering goods already in transit become invalid immediately, so the permit portfolio and the logistics documents must be reviewed together at the moment of any change of licence holder.

Insight 3: The 3-shipment allowance in Article 47(5) is the only relaxation for partial shipments, and it applies only to import permits.

The original text reads: “In the event where shipping of the consignment takes more than one shipment (partial consignment), only three shipments shall be allowed to be covered by one import permit.” The provision mentions only the import permit; whether an export permit may cover partial consignments is simply not addressed in the written law. For practical estimate purposes, this must be confirmed with TMDA before any split export consignment is planned.

Insight 4: Article 50(1) restates that unregistered devices may not be imported, and Article 50(2) opens a public interest channel.

Article 50(1) prohibits the import of any device unless it has been registered by TMDA. Article 50(2) nevertheless allows TMDA, on the request of any person or institution and on public interest grounds, to approve the import of unregistered devices. This is the statutory channel for donations and urgent public health use, but it operates case by case and never as a blanket exemption, so approval documents must be obtained before shipment and kept on file.

Insight 5: Article 55 gives TMDA discretion to revoke import and export permits.

Under Article 55, where TMDA is satisfied that an importer, exporter or consignment has contravened any provision of the Regulations, it may revoke, cancel or suspend any import or export permit issued, or any other certificate issued under the Regulations. The practical meaning is that a single compliance failure at the port can affect permits for all subsequent batches, which is why port compliance and permit renewal must be managed as linked processes rather than as separate files.

4. Practical recommendations

1. Plan permits by batch, not by year. Under the permit-per-shipment system, the annual procurement plan must be broken down into individual batch permit applications.
2. Manage validity at 6 months for import permits and 3 months for export permits, and treat expiry as immediate loss of authorisation.
3. Keep partial shipments within 3 shipments per import permit; confirm any split export consignment with TMDA in advance.
4. Check in-transit permits whenever the LRP or distributor changes, to avoid a mismatch between the permit holder and the goods.
5. Route unregistered devices through the public interest channel of Article 50(2), apply case by case and retain the approval documents.
6. Link port compliance with permit renewal in a single register, reflecting the discretion created by Article 55.

5. Verification checklist

• □ Import and export permits have been applied for batch by batch (Article 45).
• □ Validity has been recorded: import 6 months, export 3 months (Article 47(3)).
• □ One permit per batch and non-transferability have been confirmed (Article 47(4)).
• □ Partial shipments do not exceed 3 shipments (Article 47(5)); split export consignments have been confirmed with TMDA.
• □ Entry has been confirmed through a port of entry prescribed in the First Schedule (Article 49(1)).
• □ Public interest approval under Article 50(2) has been obtained for any unregistered device.
• □ A linked register of port violations and permit renewals has been established (Article 55).

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 45–50 and 55); 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.