Port Inspection and Clearance of Medical Devices in Tanzania

1. Key takeaways

Tanzania applies mandatory port inspection to imported devices. GN 315, Articles 56–58, form the core of the regime, and the obligations they impose continue even after the goods have left the quay.

• Article 56(1): no imported device may be removed from the port of entry or any other place until it has been inspected and released by an inspector.
• Article 56(2): where goods are directly released by the customs department and moved from the port of entry to another place for storage or distribution, that place is deemed to be a designated port of entry.
• Article 56(3): removal of goods from a place described in Article 56(2) remains subject to this Article.
• Article 56(4): the importer must provide all necessary documents requested by the authorised inspector at any time.
• Article 57: where an inspector suspects that a device in the consignment contravenes the Regulations or the Act, the inspector may take samples for further investigation, using the sampling form prescribed in the Third Schedule.
• Article 58: where a consignment does not meet the requirements of the Regulations, the inspector shall reject or detain it and order re-exportation at the owner’s cost; a rejection form prescribed in the Second Schedule must be completed; a copy of the airway bill or bill of lading must be submitted as evidence of re-exportation; where the inspector considers that the consignment should be destroyed, the matter must be recommended to TMDA.

The combined effect is that inspection and release, not customs clearance, is the true gate for market access. Documents must travel with the goods, sampling and rejection follow fixed procedural forms, and both the financing and the evidencing of re-exportation fall on the owner of the goods. Labelling is the most frequently inspected item at the port, and the list of ports of entry itself is subject to revision, so each shipment must be checked against the current designations.

2. Legal basis

3. Expert insights

Insight 1: The deemed port of entry in Article 56(2) is a far-reaching extension clause.

Where customs releases goods directly to an inland warehouse, that warehouse is deemed to be a designated port of entry. This means that even after the goods have left the port and entered the company’s premises, the rule in Article 56(1) that goods must not be removed before inspection and release continues to apply. A company may not unbox and distribute stock in its own warehouse while waiting for the inspector; many importers have stumbled on precisely this point, treating customs release as final clearance.

Insight 2: Re-exportation is at the owner’s cost and must be evidenced by a copy of the airway bill or bill of lading.

Article 58(1) provides that the inspector shall reject or detain the consignment and order re-exportation at owners cost, and Article 58(3) provides that a copy of the airway bill or bill of lading shall be submitted to the Authority as evidence of re-exportation. Re-exportation is therefore not only an expense but also a burden of proof: without the transport document, the re-exportation is not regarded as complete from a regulatory standpoint, and the case remains open.

Insight 3: Destruction is not decided by the inspector; it must be recommended to TMDA.

Article 58(4) provides: “Where it is in the opinion of the inspector that the consignment be destructed, he shall recommend the same to the Authority.” The decision rests with TMDA, not with the inspector, so an importer should never treat an inspector’s negative view on site as an authorisation to destroy; the formal recommendation and the Authority’s decision are separate steps.

Insight 4: The most frequent failure point at the port is labelling, and the labelling requirements are spread across two instruments.

The 11 items of Article 74(1) form the statutory baseline, and Article 74(2) requires labelling to be clear, durable and conspicuous and readily understood by the intended user. The 2024 Compendium, Part VIII §3.4(a), additionally requires household devices to carry Swahili. Because the label is the most directly visible object during a port inspection, GRZAN recommends a labelling pre-check before shipment covering both sources.

Insight 5: The list of ports of entry can be adjusted dynamically.

Article 49(2) allows the ports of entry prescribed in the First Schedule to be amended, varied or supplemented from time to time. Each shipment must therefore be checked against the currently effective port list rather than relying on past routing experience, since a port that was valid for a previous consignment may no longer be designated.

4. Practical recommendations

1. Treat inspection and release as the gating step for goods movement; do not self-distribute from a warehouse even after customs release (Articles 56(1), (2) and (3)).
2. Keep the document package with the goods (Article 56(4)): import permit, proforma invoice, registration certificate, batch and expiry records.
3. Run a labelling pre-check before shipment, focusing on the 11 items of Article 74(1) and the Swahili requirement for household devices.
4. If re-exportation is ordered, arrange submission of the airway bill or bill of lading copy in parallel (Article 58(3)).
5. Verify the port of entry list before every shipment (Article 49(2) allows dynamic adjustment).
6. Wait for the TMDA decision before any destruction; do not act on the inspector’s recommendation alone (Article 58(4)).

5. Verification checklist

• □ Awareness of the no-removal-before-inspection rule, including customs direct release to a warehouse (Articles 56(1) and (2)).
• □ Document package complete and travelling with the goods (Article 56(4)).
• □ Labelling pre-check completed before shipment (11 items of Article 74(1) plus Swahili for household devices).
• □ Currently effective list of ports of entry checked (Articles 49(1) and (2)).
• □ Awareness that re-exportation is at the owner’s cost and requires submission of a copy of the airway bill or bill of lading (Articles 58(1) and (3)).
• □ Awareness that destruction is decided by TMDA (Article 58(4)).

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 49 and 56–58; the June 2024 Compendium, Part VIII); 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.