Technical Dossier Requirements for Medical Device Registration in Tanzania

1. Key takeaways

Tanzania’s technical documentation requirements for registration are set out in Part II (non-IVD) and Part III (IVD) of the 2024 Compendium of Guidelines. Both parts provide that regardless of device class, the applicant must submit the following information (Device Details):

• Name(s): the device’s generic and brand names
• Description: a summary of the design, characteristics and performance, including packaging information
• Category: the GMDN category of the device; if the device is not categorized under GMDN and is coded under another system, this must be specified
• Intended Use/Indication(s): the intended use and/or a general description of the diseases or conditions the device is intended to diagnose, treat, prevent, cure or mitigate; the target patient population must be included
• Instructions for Use: brief information for safe use, including procedures, methods, frequency, duration, quantity and preparation
• Contraindications: situations in which the device should not be used
• Warnings: specific hazard warnings that users must know before use
• Precautions: measures and special care required for safe and effective use
• Adverse Effects: all undesirable and side effects associated with the device under normal conditions of use
• Alternative Use: any alternative practices or procedures for diagnosing, treating, curing or mitigating the disease or condition
• Storage conditions: storage conditions (which should be based on stability study results, where applicable)
• Recommended shelf-life: the recommended shelf-life (where applicable)

This is followed by the Summary Technical Documentation (STED), starting with the device description and features including description of variants and accessories, and containing: a) the principle of operation of the device; b) the risk class and the applicable classification rules; and further elements specified in the guideline.

These twelve fixed fields are the skeleton of every Tanzanian submission, for every class, and reviewers work through them field by field. Omissions in the two least intuitive fields — Adverse Effects and Alternative Use — are among the most frequent causes of queries.

2. Legal basis

3. Expert insights

Insight 1: Regulation 11 of GN 315 lists 14 statutory dossier items for Class B/C/D, which stack on top of Part II of the Compendium.

Regulation 11 requires, in addition to the information under regulation 7: (a) a description of the device and of the materials used in its manufacture and packaging; (b) the characteristics that make it fit for the medical conditions, purposes and uses for which it is manufactured, sold or represented; (c) a list of the countries other than Tanzania where the device has been sold, and a summary of any reported problems with the device and any recalls of the device in those countries; (d) a risk assessment conducted per ISO 14971 (including risk analysis and evaluation and the risk reduction measures taken to meet safety and effectiveness requirements); (e) the quality plan; (f) specifications of manufacturing and packaging materials; (g) the manufacturing process; (h) the list of standards applied in design and manufacture; (i) a detailed summary of all studies on which the manufacturer relied to confirm conformity with safety and performance requirements, including pre-clinical and clinical studies, process validation studies, where appropriate software verification studies, and literature reviews; (j) objective evidence of biocompatibility for non-IVD devices manufactured from or containing animal or human tissues or their derivatives; (k) details of investigational testing in human subjects for near-patient IVDs; (l) a bibliography of published reports; (m) copies of labels; (n) a copy of the QMS certificate.

Insight 2: Regulation 11(c) is a distinctive Tanzanian item — global sales history and the list of problems abroad.

The text reads: a list of the countries other than Tanzania where the device has been sold and a summary of any reported problems with the medical device and any recalls of the medical device in those countries. This is not a field required in most markets, and it is self-declaratory in nature: recalls abroad must be disclosed truthfully. It resonates with regulation 41 of GN 315 (incidents occurring abroad must also be reported), forming a complete chain of foreign-information obligations.

Insight 3: The seven items for non-exempt Class A devices under regulation 10 are visibly lighter, but contain three triggered requirements.

Regulation 10 requires: (a) copies of the primary and secondary labels of each component, family member and accessory of the device system; (b) instructions for use; (c) patient information leaflet (where applicable); (d) for sterile devices, the sterilization validation report; (e) for devices with a measuring function, metrological or equivalent certification; (f) for active devices, certification against electrical safety standards; (g) any other information required by TMDA. Items (d), (e) and (f) are triggered — and they correspond exactly to the three characteristics marking the notification boundary described in article 05.

Insight 4: GMDN is a mandatory field, not an option.

The Category field in Part II requires the applicant to state the GMDN category of the device, and to specify if the device is not categorized according to GMDN and is coded based on another system. GMDN is therefore the default requirement, and using another coding system requires additional explanation. This is consistent with Part I §3.4.1, which lists the GMDN code and term as pre-submission essential information.

Insight 5: The Essential Requirements checklist in Annex I covers all devices, including Class A.

Part X §2.1 of the Compendium states, when discussing software devices: this applies to all medical devices, including Class A medical devices. The Essential Requirements checklist must identify the applicable design and manufacturing requirements item by item, and justification must be recorded for any requirement judged not applicable.

4. Practical recommendations

1. Build the document skeleton on the twelve fixed fields of Part II, one subsection per field, to avoid overlooking Adverse Effects and Alternative Use, the two most frequently missed fields.
2. Prepare the foreign sales history and problem list separately (regulation 11(c)), including summaries of reported problems and recalls.
3. Issue the risk assessment as an independent report per ISO 14971, not by embedding a risk table into the STED (regulation 11(d) names ISO 14971 expressly).
4. Confirm GMDN codes and terms early; if another coding system is used, explain it in the dossier.
5. Do not miss the triggered items for non-exempt Class A devices: sterilization validation, metrological certification and electrical safety certification.

5. Verification checklist

• □ Written to the twelve fixed fields of Part II/Part III.
• □ List of countries where the device has been sold and the summary of foreign problems/recalls submitted (regulation 11(c)).
• □ Risk assessment issued as an independent report per ISO 14971 (regulation 11(d)).
• □ GMDN category completed; alternative coding system explained where used.
• □ STED contains the principle of operation and the risk class plus applicable classification rules.
• □ Non-exempt Class A triggered items completed under regulation 10 (sterilization/metrology/electrical safety).
• □ Annex I Essential Requirements checklist completed item by item, with justification recorded for non-applicable items.

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 II, Part III, Annex I, Annex II; GN. No. 315, regulations 10 and 11), 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.