Local Manufacturing Incentives and Regulatory Harmonisation in Tanzania

1. Key takeaways

Tanzania is advancing the regionalisation of device regulation along two tracks: incentives for local manufacturing and regional and international harmonisation. The first track is driven mainly by the fee structure, the second by participation in a set of named mechanisms whose depth differs between the medicines and devices sectors. Both tracks matter to any manufacturer planning an entry strategy into the Tanzanian market.

On the local manufacturing side: the fee schedule on the TMDA website lists a separate rate in Tanzania shillings (TZS) for locally manufactured devices, substantially lower than the United States dollar rates applied to imported products:

On the regional and international harmonisation side: the TMDA website lists the mechanisms in which it participates, including the East African Community Mutual Recognition Procedures (EAC-MRP), the African Medicines Regulatory Harmonisation initiative (AMRH), processes related to the African Medicines Agency (AMA), and the WHO Collaborative Procedure. On the device side there are separate records of participation in the African Medical Devices Forum (AMDF), the Global Harmonization Working Party (GHWP) and the IMDRF.

2. Legal basis

3. Expert insights

Insight 1: the gap between local and imported rates is a policy instrument, not a currency conversion.

Take Class A registration: 100,000 TZS locally versus 500 USD for imports. This is not the result of an exchange rate calculation but a deliberate rate differential. Tanzania uses the fee structure to promote local manufacturing, and together with Article 24 of GN 315 (manufacturing requires a premises licence) and Part IV §3.2.3 (domestic manufacturers must be registered with the TMDA first) it forms a complete local manufacturing management framework. Investment decisions that price only the imported fee schedule miss the size of the incentive intended for localised production.

Insight 2: Part IV §3.2.3 counts the final manufacturing stage as manufacturing, so the threshold for localisation is lower than expected.

Part IV §3.2.3 provides that manufacturers within Tanzania must first be registered with the TMDA before their products can be notified, and this applies to entities participating in the final manufacturing process, including assembly, resizing, cutting and/or packaging. This means that establishing a packaging line in Tanzania may already constitute local manufacturing and attract the local rates — provided the entity has completed TMDA registration. Companies planning localisation should therefore evaluate whether their intended activity falls within this definition before committing to the imported-fee cost model.

Insight 3: the TMDA participates in regional harmonisation on both the medicines and device tracks, but the depth of device-side harmonisation differs.

The TMDA website lists EAC-MRP, AMRH, the AMA and the WHO Collaborative Procedure under the harmonisation sections related to medicines; on the device side it records participation in AMDF, GHWP and IMDRF separately. At present there is no evidence that devices enjoy a regional mutual recognition procedure comparable to that for medicines. The practical warning: do not transfer the EAC-MRP experience from medicines to devices — as of the verification date, devices still require separate marketing authorisation country by country. Budgets built on the assumption of regional recognition would fail.

Insight 4: MDSAP is currently the most concrete international mutual recognition landing point on the device side.

The public notice of 24 September 2026 is the only dated, clearly specified international mutual recognition development on the device side. Unlike the parallel mechanisms on the medicines side, the device-side international interface currently operates mainly at the level of quality system audits (QMS), not technical review. This matters strategically: audit evidence quality has a direct regulatory return, while waiting for review-level recognition has no current basis.

Insight 5: the compliance obligations of local manufacturing are not reduced.

Part IV §3.2.3 further provides that where refurbished second-hand devices are refurbished by a third party other than the original manufacturer, that third party bears the manufacturer responsibilities described in the guideline. A local refurbisher must therefore hold ISO 13485 to the manufacturer standard and discharge all associated duties — the favourable rates do not equal a reduction in obligations. This point is frequently overlooked by companies entering through refurbishment or packaging arrangements.

4. Practical recommendations

1. When assessing the feasibility of a factory or packaging line in Tanzania, include the local rate advantage in the model, together with the costs of TMDA premises registration and quality audits.
2. Confirm the definition of the final manufacturing stage (including assembly, resizing, cutting and packaging) and determine whether the activity constitutes local manufacturing.
3. Do not transfer the medicines-side EAC-MRP to devices — devices still require separate marketing authorisation in each country.
4. Configure refurbishment operations to the manufacturer standard (ISO 13485 plus TMDA registration).
5. Track AMDF, GHWP and IMDRF progress on the device side, and whether the TMDA issues an operational document on regional device mutual recognition.

5. Verification checklist

• □ The difference between local (TZS) and imported (USD) rates has been confirmed and entered into the cost model.
• □ It has been determined whether activities in Tanzania constitute the final manufacturing stage (including packaging).
• □ The domestic manufacturing entity has completed TMDA registration (Part IV §3.2.3).
• □ The medicines-side EAC-MRP experience has not been transferred to devices.
• □ Refurbishment operations are configured with ISO 13485 to the manufacturer standard.
• □ A tracking list of device-side regional harmonisation mechanisms has been established (AMDF / GHWP / IMDRF).

Regulatory information verified as of 29 October 2026. All content cited in this document has been checked against the TMDA website fee pages and harmonisation pages and the June 2024 Compendium, Part IV §3.2.3; the review is repeated whenever the regulations are updated.

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