Change Types for Approved Medical Devices in Tanzania

1. Key takeaways

Change management in Tanzania is governed by the Guidelines on Submission of Application for Change(s) to Approved Medical Devices and In-Vitro Diagnostics (reference TMDA/DMD/MDA/G/003, Rev. 00, First Edition, June 2022, issued under Article 23 of GN 315). The Guidelines divide changes into three categories, each with its own implementation conditions.

The Guidelines also provide 5 main decision trees plus 8 specific decision trees (Decision Tree A–H): the main decision tree; manufacturing process/facility/equipment (A); manufacturing quality control procedures (B); design (C); sterilisation (D); software (E); non-IVD materials (F); IVD materials (G); and labelling (H).

2. Legal basis

3. Expert insights

Insight 1: The concept of significant change is the common parent of major and minor changes, and its test is three consequences.

The opening definition of §3.3 provides that both major and minor changes under these Guidelines are regarded as significant changes and must be reported to TMDA. A significant change is one shown by risk analysis to have a potential impact on the function, performance, usability or safety of the registered or listed device or IVD. Such a change may: a) introduce a new hazard not previously addressed; b) adversely affect the risk associated with an existing hazard; or c) alter the way an existing or new risk is presented to the user, which may involve labelling changes or a new intended use.

Reporting must occur before implementation (“Reporting of change should occur prior to its implementation”).

Insight 2: Several items in the 11-item notifiable list are highly relevant to daily operations.

§3.3 lists items a) to k), 11 in total: a) labelling changes involving only layout, colour, font size and design without changing the prominence of cautions, warnings and contraindications; b) adding or deleting a language not required by TMDA; c) adding or deleting notified body approvals (such as CE marking); d) updating distributor information (including the European authorised representative) without affecting the approved information of the device; e) adding or deleting barcodes without changing registered information; f) adding a UDI without changing approved information; g) changes to the format of existing label date fields (for example from MMYY to DDMMYY); h) regulatory status changes of listed models following rejection or withdrawal by any notified body; i) changes of raw material supplier (excluding suppliers of medicinal substances and biological materials) without changing specifications; j) changes to the scope of QMS certification without affecting the registered device; k) changes of certification body without changing the scope of the QMS certificate.

Insight 3: Decision Tree A asks first whether safety or efficacy is affected; a yes answer means major.

Appendix 2 (Decision Tree A) asks whether a change in the manufacturing process, facility or equipment affects the safety or efficacy of the device. If yes, it is a major change. If the change is merely the addition of a new manufacturing site (with no change to the manufacturer’s name and address on the label), the new site must be included in the manufacturer’s quality system certificate and a change application containing a declaration must be submitted. If the change concerns the manufacturing process, facility or equipment of a supplier, with no change to device specifications or incoming inspection, it is a minor change. For a combination product, a manufacturing process, facility or equipment change is a major change. If a sterilisation process or method is involved, the assessment moves to Decision Tree D. Otherwise the change is notifiable and is recorded in the QMS.

Insight 4: Decision Tree H treats a restriction of indications as major, which is counter-intuitive.

The relevant Appendix content provides that changes to intended use or indications require a new application unless the change falls within the set of approved indications; changes within the approved set should be submitted at renewal or as a change notification. However, where a restriction on the indications for use is introduced out of concern for the safe and effective use of the device, requiring the addition of a contraindication, this is treated as a major change. In other words, narrowing the indications for safety reasons must follow the major change route precisely because a contraindication must be added. Separately, minor clarifications of the wording of existing warnings and cautions may not require an application, but adding or deleting contraindications, or deleting warnings or cautions, are major changes.

Insight 5: Decision Tree G draws the line for IVD material changes at additional clinical testing.

§5.8 provides that a change of IVD materials which requires additional clinical samples to be tested to determine performance characteristics is a major change – unless the additional clinical testing merely confirms that the changed IVD still complies with the approved performance specifications and no labelling change is needed. A change that alters the working principle (for example from immunofluorescence to ELISA) is major. Changes to methods – reaction components such as calibrators, or specimen processing, incubation time and temperature – require a change application where they alter performance characteristics and this is reflected on the label.

4. Practical recommendations

1. Establish a change register; every change is run through the applicable decision tree before it starts, and the determination is archived.
2. Never implement a major change before approval; for minor changes wait the full 10 days without objection; notifiable changes may be implemented first and reported afterwards.
3. Route software changes through Decision Tree E; do not apply the hardware trees (A/B/C/D).
4. For IVD material changes, self-check first whether additional clinical sample testing is needed – this is the dividing line between major and not major.
5. When narrowing indications for safety reasons, follow the major change route and add the contraindication at the same time.
6. Report all changes since registration at renewal (including approved and pending approval changes) – Part I §3.3.3(a).

5. Verification checklist

• □ Classification into the three categories of TMDA/DMD/MDA/G/003 (major/minor/notifiable) has been completed.
• □ The determination has been walked through the applicable decision tree (A–H) and archived.
• □ The letter of acceptance has been received before implementing any major change.
• □ For minor changes, the full 10 days have elapsed with no objection letter.
• □ Notifiable changes have been confirmed against the 11-item list and reported after implementation.
• □ Software changes use Decision Tree E; IVD material changes use Decision Tree G.
• □ The renewal change summary includes pending approval changes (Part I §3.3.3(a)).

Regulatory information verified as of 29 October 2026. All provisions cited in this document were checked against the official texts published by TMDA (TMDA/DMD/MDA/G/003 §3.1, §3.2, §3.3, §5.8, §5.9 and Appendix 2 and the relevant decision tree Appendices; GN. No. 315, Article 23; the June 2024 Compendium, Part I §3.3.2 and §3.3.3); the review is repeated whenever the regulations are updated.

• Tanzania local resources: GRZAN can coordinate licensed local responsible person (LRP) and distributor resources covering online submission, sample delivery, quality audit support and port release.
• Service capabilities: classification determination, registration and listing pathway selection, preparation and localisation of technical documentation (CSDT/STED), GMDN and grouping strategy, clinical evidence organisation, software and AI device submissions, change management, vigilance and PMS reporting, annual retention fee and renewal management.
• Contact: hito.lin@grzan.cn; website www.grzan.cn.