Notification Scope in Tanzania: Five Categories from Class A to Medical Gases

1. Key takeaways

The notification scope in Tanzania is far wider than Class A low-value consumables. Part IV §1 of the June 2024 Compendium lists five categories eligible for the notification route:

1. Class A devices and IVDs that are non-active, non-sterile and without measuring function; where these characteristics are absent, a device may still use notification if it is not used directly for diagnosis and designed exclusively for household use (official examples: bathroom scales for weight monitoring, height-measuring equipment).
2. Devices and IVD kits whose contained devices are already registered or notified in Tanzania.
3. Veterinary devices and IVDs.
4. Laboratory equipment and apparatus.
5. Medical gases.

The direct conclusion from this scope: veterinary devices in Tanzania follow notification rather than registration (Part IV §3.5 states expressly that medical devices (MDR) and in-vitro diagnostics (IVDDs) intended to be used in animals have been exempted from registration), but the products must be intended by the manufacturer for animal care and labelled accordingly. The scope also means that laboratories buying general equipment, and hospitals procuring medical gases, interact with TMDA through a lighter administrative channel — a genuine difference from markets where all products funnel into one review pipeline.

2. Legal basis

3. Expert insights

Insight 1: The veterinary exemption from registration is conditional, and the condition is written on the label.

Part IV §3.5(a): veterinary devices and IVDs are exempted from registration, applicable to products that the manufacturer clearly intends for animal care and that must be labelled as such. Part VIII §5.1(t) echoes the labelling requirement: devices for animal use must be marked “For Veterinary Use” or “Device for Veterinary Uses Only”. In other words, without the marking, the exemption loses its basis. A dual-use product whose labelling does not distinguish human from animal use cannot claim the veterinary channel, and its marketing status in Tanzania remains unsettled until the labelling question is resolved.

Insight 2: The notification dossier for medical gases is a standalone five-item set, with aerosols excluded.

Part IV §3.4(b) requires notification submissions for medical gases to include: first, a copy of controlled current standard operating procedures or a production agreement (covering storage, transport and distribution procedures); second, the results of daily gas quality checks for consecutive production batches over at least 3 months (where applicable); third, a comprehensive plan ensuring that each batch recipient is traceable; fourth, mock-up labels of the finished product in its sale/distribution packaging; fifth, premises certification (domestic) or proof of GMP compliance (overseas). §3.4(c) states expressly: aerosol preparations, or solid mixtures used to generate gases, are not eligible for the notification route.

Insight 3: Kits may use notification, but a kit containing a registrable device must state its TMDA registration number.

Part IV §3.3: device groups, families or kits may be notified under a single application, but in addition to the technical requirements of §2.2 the applicant must first describe every component completely; second state the intended purpose of each component; and third, for a kit containing a device subject to registration (such as sutures), provide the TMDA registration number of that device. This admits combination products into the notification channel while pulling the high-risk component back under registration control through the registration number requirement.

Insight 4: Manufacturer responsibility transfers for refurbished devices — a hidden clause in the notification requirements.

Part IV §3.2.3 provides: manufacturers within Tanzania must be registered with TMDA before notifying their products; this applies to parties participating in the final manufacturing process, including assembly, resizing, cutting and/or packaging. The more consequential sentence follows: for second-hand devices refurbished by a third party other than the original manufacturer, that third party assumes the manufacturer responsibilities described in the guidance. This means a refurbisher is treated as a manufacturer in Tanzania, must hold an ISO 13485 certificate and must discharge every manufacturer obligation — a status many distributors never anticipate.

4. Practical recommendations

1. Check the five notification categories before discussing the classification level. Veterinary devices, laboratory equipment and medical gases may have an independent notification channel even when they cannot simply be placed in Class A low risk.
2. Run a labelling compliance check for veterinary products without exception: the label must carry “For Veterinary Use” or “Device for Veterinary Uses Only”.
3. Prepare medical gas files as the five-item set; the daily quality checks for at least 3 months of consecutive batches require production sampling planned more than 3 months ahead and are the critical-path item of the notification.
4. Assess refurbishment businesses separately. A third-party refurbisher carries manufacturer responsibility in Tanzania and must hold ISO 13485 and be registered with TMDA; operating as a mere distributor is not available.

5. Verification checklist

• □ The five categories of Part IV §1 have been checked to determine whether the product falls within them.
• □ Veterinary device labels contain “For Veterinary Use” or “Device for Veterinary Uses Only”.
• □ For medical gases, daily quality check results for at least 3 months of consecutive batches have been prepared.
• □ Where a kit contains a registrable device, its TMDA registration number has been obtained.
• □ Domestic manufacturers (including assembly, resizing, cutting and packaging steps) are registered with TMDA.
• □ Refurbishment operations are configured to the manufacturer standard, with ISO 13485 and an accountable legal entity.

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 IV §1 and §3.2–§3.5; Part VIII §5.1(t); GN. No. 315 Section 13); 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.