Registration vs Notification: Choosing the Market Pathway in Tanzania

1. Key takeaways

The market pathway in Tanzania is decided by three decision points applied in sequence, and a company can complete the determination itself before submission. Getting all three right at the start is what keeps a project on schedule; getting any one wrong can mean a rejected application and a fee that is not refunded.

First cut — registration or notification. Compendium Part I §3.2: registration is the main pathway and applies to all Class B, C and D devices and IVDs, as well as to Class A devices with the following features: (a) active devices; (b) a measuring function; (c) sterile. Notification applies to Class A devices and IVDs that do not meet the registration criteria above. Article 5(2) of GN 315 adds: where multiple rules apply, the highest risk classification prevails.

Second cut — whether a manufacturing site quality audit is triggered. Quality audit guidelines §7.1.1: the audit applies to sites manufacturing Class C and D products, and to sites manufacturing Class A and B invasive and/or sterile products. Whether a desk review or an on-site audit is conducted is decided by the TMDA on the basis of risk assessment (§7.1.2); if a desk review suspects critical or major non-conformities, it is converted into an on-site audit under §9.3.

Third cut — timeline and budget. Compendium Part I §3.4.4–§3.4.8: the full process takes about 43 working days for Class A/B and about 93 working days for Class C/D, while notification takes only 5 working days; these time limits exclude on-site inspection time. Fees are tiered by class (imported products, USD): device notification 100, Class A 500, Class B/C/D 2500; IVD notification 100, Class A 300, Class B 1000, Class C 1500, Class D 2000.

A consequence that is easily overlooked: a registration certificate is valid for 5 years (Article 17(1) of GN 315), while a notification approval is valid for 3 years (Compendium Part I §5.1) — the pathway choice simultaneously determines the renewal rhythm.

2. Legal basis

3. Expert insights

Insight 1: the Class A triggers for registration are three parallel features, listed as a/b/c rather than joined by a conjunction.

§3.2 writes the Class A registration triggers as (a) Active devices; (b) Measuring function; (c) Sterile, without an and/or connector. The working interpretation is that a match on any one feature means registration: a sterile tongue depressor (Class A, sterile) goes through registration, not notification. Conversely, only an ordinary Class A consumable that is non-sterile and has no measuring function may be notified. Treating the three features as cumulative rather than alternative is a common reading error that leads directly to a rejected notification application.

Insight 2: the timelines differ by more than double, but the gap lies mainly in queuing and administration, not in review.

Breaking down §3.4.4–§3.4.8: the review stage takes 23 working days for Class A/B and 40 working days for Class C/D (the official text at this point reads 40 working days for class A and B devices, which against the same section’s Class C/D context should be a misprint for Class C/D; this table adopts 40 working days for Class C/D based on the context, and readers should defer to the current official text); what really separates the two classes is scheduling (≤10 versus ≤20) and administrative processing (≤5 versus ≤25). In other words, the risk point of a Class C/D project is not the technical dossier itself but the scheduling wait and the approval chain. Project plans should therefore build buffer into the administrative stages rather than into review quality.

Insight 3: the trigger surface for quality audits is broader than high risk.

§7.1.1 brings Class A/B invasive or sterile products into the quality audit as well. A Class B sterile syringe project, for example, is assessed at the B/C/D fee tier of 2500 USD and the Class A/B timeline of 43 working days, yet still requires a manufacturing site quality audit — the fee tier and the audit trigger are not the same dividing line. Companies allocating budget by fee tier alone will under-resourced the audit preparation work that these projects still require.

Insight 4: the fee tiers are flat for devices and stepped for IVDs.

The imported device tier has only three bands: 100 / 500 / 2500 — Classes B, C and D cost the same; IVDs rise step by step at 100 / 300 / 1000 / 1500 / 2000. For devices this means moving from Class B to Class D adds no assessment fee, but it does add quality audit, clinical evidence and vigilance investment; for IVDs, every step up in class changes the assessment fee. Portfolio planning should model the two product families on different cost curves rather than extrapolating from one to the other.

Insight 5: notification is not a simplified registration — the dossier and the output differ.

Notification involves only a first assessment, within 5 working days (§3.4.8); the output is an approval letter, not a registration certificate (opening of Part I §5); and it is valid for 3 years rather than 5 years (§5.1). Choosing the wrong pathway is not a matter of correction — §3.4.2 is explicit: a notification application for a product that does not qualify will be rejected and returned. The practical estimate is that a rejected notification costs the full fee plus a restart, so the pathway determination deserves a documented sign-off before any payment is made.

4. Practical recommendations

1. Write the three decision points into a one-page determination table at the project stage: class → pathway → whether a quality audit is triggered → timeline and fee tier.
2. For Class A, ask the three questions of active, measuring and sterile first; a match on any one means preparing for registration, not notification.
3. Start quality audit preparation in parallel for Class C/D projects; the review timeline counts only the dossier, not the on-site inspection.
4. Plan internal milestones on 43 / 93 / 5 working days, and do not rely on unofficial timelines circulating online such as 4–6 months or 9 months (practical estimate).
5. Schedule three lines separately: the 5-year registration certificate, the 3-year notification approval and the 3-year quality audit certificate.

5. Verification checklist

• □ The risk class has been determined, and the highest-class rule of Article 5(2) of GN 315 has been checked where multiple rules apply.
• □ The choice between registration and notification has been determined, and the three questions of active, measuring and sterile have been answered for Class A.
• □ Whether a quality audit is triggered has been determined (Class C/D; Class A/B invasive or sterile).
• □ Scheduling is based on 43 / 93 / 5 working days (excluding on-site inspection).
• □ The budget has been calculated on the imported USD tiers (devices 100/500/2500; IVDs 100/300/1000/1500/2000).
• □ The expiry dates of the registration certificate (5 years), notification approval (3 years) and quality audit certificate (3 years) have been recorded separately.

Regulatory information verified as of 29 October 2026. All content cited in this document has been checked against the TMDA website fee pages and the official published text (June 2024 Compendium, Part I §3.1, §3.2, §3.4.4–§3.4.8 and §5.1; quality audit guidelines §7.1.1, §7.1.2, §9.3 and §9.4; GN. No. 315, Articles 5 and 17(1)); the review is repeated whenever the regulations are updated.

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