Tanzania Medical Device Registration versus Notification: Routes, Criteria and Validity

1. Key takeaways

Marketing authorization in Tanzania offers only two routes: registration and notification. The dividing line is drawn by Part I §3.2 of the June 2024 Compendium:

• Registration: applies to all Class B, C and D devices and IVDs, and to Class A devices possessing any one of the following characteristics:
  • a) Active devices
  • b) Measuring function
  • c) Sterile
• Notification: reserved for Class A devices and IVDs that do not meet the registration criteria.

Two consequences follow directly. First, registration certificates are valid for 5 years and notification approvals for 3 years (Part I §5.1). Second, a notification application undergoes first assessment only, with a processing time of 5 working days (Part I §3.4.8), whereas registration runs through all four stages of scheduling, assessment, quality assurance and administrative processing. The two routes therefore differ not only in dossier depth but in validity period, review structure and total elapsed time, and choosing between them is a strategic decision rather than a paperwork choice.

2. Legal basis

3. Expert insights

Insight 1: The official wording uses “and” in two places, but the practical meaning is that satisfying any single characteristic requires registration.

Part I §3.2 reads: select class A devices that possess the following characteristics: a) Active devices; b) Measuring function; and c) Sterile — using “and”. The opening paragraph of Part II, however, states that the notification route is “not applicable for class A medical devices supplied in non-sterile state, non-active and non-measuring function. Such devices are exempted from registration”. Read together, the exemption requires all three characteristics to be absent simultaneously (non-sterile + non-active + no measuring function), which reversed means satisfying any one of them requires registration. GRZAN recommends operating on the any-one-means-register reading — a submission on the looser reading is rejected and returned at the §3.4.2 screening step for applying under the wrong product class.

Insight 2: This is the most visible institutional difference between Tanzania and Kenya.

Kenya’s PPB applies listing to Class A devices with a set of nine documents; Tanzania’s notification is not only gated by three technical characteristics, but its approval is valid for only 3 years, and the notification route is extended to veterinary devices, laboratory equipment and medical gases (see article 06). Transplanting Kenyan listing experience directly into Tanzania produces errors in validity planning, dossier structure and product scope. Each market must be worked from its own guidance documents.

Insight 3: The 3-year versus 5-year split directly reshapes renewal scheduling and annual retention fee rhythm.

Part I §5.1 states expressly: registration is valid for 5 years and notification approval for 3 years, unless suspended or cancelled by TMDA or terminated by the authorization holder. The validity of both is simultaneously subject to three conditions: a) payment of the annual retention fee under the current fees regulations; b) submission of PMS reports; and c) submission of reports on undesirable effects related to the use of the device. A notification holder that plans renewals on a 5-year cycle will find the approval expired in year 3, with the device back under the Section 6 prohibition in the interval.

Insight 4: Notification is not a simplified registration; the dossier structure is different.

The notification technical requirements in Part IV and the registration technical requirements in Part II are not the same set. Notification requires: a product description covering 5 items; photographs of the commercial packaging with all faces clearly visible; mock-ups of the primary and secondary packaging labels; copies of the IFU, user manual and package insert; the manufacturer’s ISO 13485 certificate (issued by a recognized conformity assessment body, CAB); a Declaration of Conformity (DoC) addressed to TMDA, completed per Annex I of the Compendium and signed and stamped by the manufacturer; the device specifications and a list of applicable standards; and samples. It does not require a full STED.

4. Practical recommendations

1. Run the three-characteristic screening first for every Class A product: does it contain a power source or driving energy? Is it used for measurement? Is it supplied sterile? Any “yes” means preparing for registration.
2. Do not choose notification to save fees. Notification fees are indeed lower (USD 100 for import versus USD 500 for Class A registration), but a wrong selection is rejected and returned, and the 1–2 working-day issue time at screening is wasted.
3. Set the renewal cycle for notification holders at 3 years, and start at least 90 days before expiry (Section 17(4) of GN 315).
4. The DoC must use the Annex I template of the Compendium, completed, signed and stamped by the manufacturer; a self-drafted version is not accepted.

5. Verification checklist

• □ The three-characteristic screening (active / measuring function / sterile) is complete with the determination on record.
• □ Operation on the reading that satisfying any one characteristic requires registration has been confirmed.
• □ Validity periods confirmed: 5 years for registration, 3 years for notification.
• □ The notification document list has been confirmed different from the registration document list.
• □ The DoC uses the Annex I template of the Compendium and is signed and stamped by the manufacturer.

Regulatory information verified as of 29 October 2026. All provisions cited in this article were checked against the texts officially published by TMDA (June 2024 Compendium Part I §3.2 / §3.4.8 / §5.1, Part II, Part IV; GN. No. 315 Sections 13 and 17); the content is re-reviewed whenever the regulations are updated.

• Local resources in Tanzania: GRZAN can coordinate licensed local responsible persons (LRP) and distributor resources covering online submission, sample delivery, quality audit support and port clearance.
• Service capabilities: classification determination, route selection between registration and notification, technical documentation (CSDT/STED) preparation and localization, GMDN coding and grouping strategy, clinical evidence organization, software and AI device submissions, change management, vigilance and PMS reporting, annual retention fees and renewal management.
• Contact: hito.lin@grzan.cn; website www.grzan.cn.