Proforma Invoice Requirements for Tanzania Import Permits
Updated: 2026-11-12 · GRZAN Regulatory Team · Verification date 2026-10-20
1. Key takeaways
Tanzania attaches strict format requirements to the proforma invoice that supports an import or export permit application. GN 315 Article 46 sets out the mechanics, and each element is mandatory rather than advisory.
- Article 46(1): the application must be made in the form prescribed in the Third Schedule.
- Article 46(2): the form must be accompanied by the original proforma invoice and two (2) copies, duly filled and signed by the incharge of the business.
- Article 46(3): the proforma invoice must state 11 items for each device.
The eleven-item list:
(a) number and date; (b) name of the supplier and/or manufacturer; (c) country of origin; (d) brand name or proprietary name; (e) product registration number issued by TMDA; (f) quantity, packing specifications, unit price and total price in convertible currency; (g) batch or lot number; (h) date of manufacture and date of expiry; (i) mode of transport (sea, air or land); (j) port of entry; (k) signature and stamp of the supplier.
Read together, these items turn the proforma invoice into the central control document of the transaction. Items (e), (g), (h) and (j) tie the paper file to the regulatory status of the product, the physical batch and the border logistics, which is why inconsistencies among them are treated as defects of the application itself rather than as clerical errors. A template built directly on items (a) to (k) is therefore the most reliable way to keep every permit file complete.
2. Legal basis
| Instrument | Reference | Publication date | Provisions |
|---|---|---|---|
| The Tanzania Food, Drugs and Cosmetics (Control of Medical Devices) Regulations, 2015 | GN. No. 315 | 31 July 2015 | Articles 46(1), 46(2), 46(3)(a)–(k); Third Schedule |
| The Tanzania Medicines and Medical Devices (Fees and Charges) Regulations, 2022 | Fees Regulations (2022) | 2022 | Fee rates applicable to import and export permits |
3. Expert insights
Insight 1: The original plus 2 copies requirement dates from a paper-based era; the degree of electronic acceptance should be confirmed with TMDA.
Article 46(2) states expressly: “original proforma invoice and two (2) copies, duly filled and signed by the incharge of the business”. Tanzania has since launched an online application system for import and export permits (the TMDA website e-Services menu lists an Import and Export Permit Application service), but the statutory text has not been amended in parallel. GRZAN’s practice is to prepare scanned copies according to the upload requirements of the online system while retaining the original for verification, always following the actual requirements of the TMDA portal where they differ from the letter of the regulation.
Insight 2: The TMDA product registration number in item (e) is the most common single point of failure.
The proforma invoice must display the product registration number issued by TMDA. This means that a product must be registered or listed before an import permit can be applied for, which forms a double lock together with Article 50(1) (no import of unregistered devices). A frequent corporate mistake is to arrange shipment before the registration certificate is issued, leaving the proforma invoice without a registration number and the whole consignment non-compliant at the application stage.
Insight 3: Items (g) and (h) bind the documentation to the product at batch level.
The proforma invoice must state the batch or lot number and the dates of manufacture and expiry. This is not merely customs information: together with the distribution records required by Article 39(2) (which must support complete and rapid recall) and the labelling requirements of Article 74(1)(d)(h) (batch number and expiry date), it forms a batch-level traceability chain. The batch number must be identical in all three places, so a mismatch discovered on one document should trigger a check of the other two.
Insight 4: Item (j) requires the port of entry to be fixed in advance, in line with Article 49(1).
Article 49(1) requires devices to enter Tanzania only through ports of entry prescribed in the First Schedule, and item (j) requires the port of entry to be stated on the proforma invoice. The two must be consistent. If the port is changed mid-route, both the proforma invoice and the permit must be handled in parallel, because a permit naming a port different from the actual arrival point creates an avoidable compliance gap.
Insight 5: Item (i) offers a three-way choice of transport mode, which determines the applicable ports and inspection arrangements.
The mode of transport must be sea, air or land. Tanzania’s main seaport is the Port of Dar es Salaam, the main air gateway is Julius Nyerere International Airport, and land transport involves border posts with neighbouring countries. The choice made under item (i) determines which of the designated ports listed under Article 49 apply to the consignment, so transport planning and permit drafting should be decided together rather than sequentially.
4. Practical recommendations
- Build the eleven items into a proforma invoice template and use it as a mandatory pre-issuance checklist.
- Confirm that the product registration number has been obtained before scheduling shipment – item (e) cannot be completed retrospectively.
- Keep the batch number, date of manufacture and date of expiry identical across the proforma invoice, the distribution records and the physical label.
- Fix the port of entry at the proforma invoice stage; if the port changes, handle the permit in parallel.
- Retain the original proforma invoice and confirm the electronic acceptance method on the TMDA portal.
- Have the invoice signed by the incharge of the business (Article 46(2)), not by an ordinary sales representative.
5. Verification checklist
- □ The proforma invoice contains all 11 items (a–k).
- □ The original plus 2 copies are attached and signed by the incharge of the business (Article 46(2)).
- □ Item (e), the TMDA product registration number, is filled in and the registration or listing is in force.
- □ The batch number, date of manufacture and date of expiry under items (g) and (h) are identical to the physical label and the distribution records.
- □ The port of entry under item (j) is fixed and complies with the First Schedule (Article 49(1)).
- □ The mode of transport under item (i) (sea, air or land) is clearly stated.
- □ The electronic acceptance method on the TMDA portal has been confirmed and the original is retained.
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 46(1)–(3), 49(1), 39(2) and 74(1)); 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.
Disclaimer
Prepared by GRZAN from publicly available regulation. It is provided for general information only and does not constitute legal advice. Legislation and official fees are subject to change by the competent authority.
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