GMDN Coding and Device Grouping Rules in Tanzania

1. Key takeaways

Tanzania has hard rules on how much can go into one application. Part I §3.3.1 of the 2024 Compendium of Guidelines: an application may only contain one of the following:

• a) A single medical device
• b) One medical device family
• c) One medical device system
• d) One medical device group

In principle, a separate application is required for each medical device, but grouping is permitted, provided the manufacturer has demonstrated that the devices submitted together meet the grouping criteria. The criteria are set out in Part IX, the Guidelines on Grouping of Devices and IVDs, which provides five decision flowcharts: FAMILY, SYSTEM, IVD TEST KIT, IVD CLUSTER and GROUP.

Getting grouping right at the start determines both the fee level and the flexibility of future portfolio changes. The rules below show why grouping decisions are best treated as strategic choices, documented against the official flowcharts, rather than administrative conveniences decided late in the process.

2. Legal basis

3. Expert insights

Insight 1: Regulation 7(1) of GN 315 and the Compendium form a principle-plus-exception relationship.

Regulation 7(1): an application for registration of a device shall be made in respect of each single device, or one device group, or one device family, or one device system. Regulation 7(3)(c) further requires the application to state the identification of the device, including the identification of any device that is part of a system, test kit, device group, device family or group of device families. In other words, the four forms in the statute match the Compendium exactly: single/group/family/system. There is no fifth form, and no general catch-all that would allow loose combinations of unrelated products in a single file.

Insight 2: GMDN is one of the five pre-submission essentials and is bound to the Category field.

Part I §3.4.1 requires the following before submission: a) device class; b) intended use; c) GMDN code and term; d) conformity assessment certificate; e) declaration of conformity. The Category field in Part II requires the applicant to state the GMDN category of the device. GMDN is therefore not merely a data entry item: it is also an input to the grouping decision — sharing the same GMDN category is usually one of the preconditions for forming a family.

Insight 3: A wrong grouping decision becomes a non-changeable matter at the change stage.

TMDA/DMD/MDA/G/003 §4(h) lists the addition of models that do not conform to the family/operation package/group definitions among matters that cannot be processed as change applications; §4(i) lists likewise the addition of devices under a brand name different from the registered device or IVD. In both cases, only a new application is possible. In other words, if grouping is made too broad at the outset, adding models later will be blocked and pushed back to a new application; if grouping is made too narrow, additional application fees must be paid. Both errors are avoidable with an early flowchart exercise.

Insight 4: IVDs have two flowcharts independent of non-IVDs — test kit and cluster.

Part IX sets up two separate decision flowcharts for IVDs, IVD TEST KIT and IVD CLUSTER, alongside the three non-IVD flowcharts of FAMILY, SYSTEM and GROUP. This parallels the treatment of IVD classification in Part VI as a separate track — Tanzania manages IVDs institutionally as an independent category, and the grouping logic reflects that separation.

Insight 5: Groups, families and kits filed under notification require a component-by-component description.

Part IV §3.3: device groups, families or kits may be notified under a single application, provided that (1) each component is fully described; (2) the intended use of each component is stated; and (3) for kits containing devices that require registration (such as sutures), the TMDA registration number of that device must be provided. This is the counterpart of the grouping rules on the notification pathway.

4. Practical recommendations

1. Run the relevant Part IX flowchart before submission and archive the decision process as the grouping rationale.
2. Confirm GMDN codes and terms model by model, and build a model-to-GMDN mapping table to submit with the application.
3. Group conservatively against the official definitions, to avoid later model additions being blocked by §4(h) into a new application.
4. Treat cross-family or cross-brand additions as new applications (§4(h), §4(i)); do not gamble on the change route.
5. For IVDs, use the test kit or cluster flowcharts, and do not borrow the non-IVD family/system rules.

5. Verification checklist

• □ Confirmed that each application contains only one of the four forms: single device/family/system/group.
• □ Relevant Part IX decision flowchart completed and archived.
• □ GMDN code and term confirmed before submission (§3.4.1(c)).
• □ Model-to-GMDN mapping table established.
• □ Aware that §4(h) (new models not conforming to grouping definitions) and §4(i) (different-brand additions) require new applications only.
• □ IVDs assessed with the test kit/cluster flowcharts, not with the non-IVD rules.

Regulatory information verified as of 29 October 2026. All provisions cited in this document were checked against the official published texts of TMDA (the June 2024 Compendium of Guidelines, Part I §3.3.1 and §3.4.1, Part II, Part IX; GN. No. 315, regulation 7; TMDA/DMD/MDA/G/003 §4(h) and §4(i)), and will be re-checked when the regulations are updated.

• Tanzania local resources: licensed Local Responsible Person (LRP) and distributor resources can be coordinated to cover online submission, sample delivery, quality audit cooperation and port clearance.
• Service capabilities: classification determination, registration and notification pathway selection, technical documentation (CSDT/STED) preparation and localization, GMDN 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.