Un-Permissible Changes Requiring New Applications in Tanzania

1. Key takeaways

TMDA/DMD/MDA/G/003 §4 (UN-PERMISSIBLE CHANGES) sets out a negative list, introduced in the official wording as follows:

The following changes do not qualify to be applied as changes of the approved product. The manufacturer should consider to file a new application for approval instead.

In other words: these 11 items cannot be processed as change applications and require a new application instead.

The eleven-item list:

a) changes that result in a change of the risk classification of the approved device or IVD;

b) changes to the specific disease, condition or risk factor that an IVD is intended to detect, define or identify;

c) changes to the approved intended use of the device or IVD;

d) changes to the analyte or measurand (the specimen tested);

e) changes to the antigens, antibodies, primers or solid phase of an IVD;

f) changes to the active pharmaceutical ingredient combined with a registered device;

g) changes to a registrable drug acting in an auxiliary role in the device;

h) addition of new models that do not meet the grouping criteria (the family/accessory pack/group definitions of the device or IVD);

i) addition of devices under a brand name different from the registered device or IVD;

j) a change of the test result format from qualitative to quantitative or from quantitative to qualitative;

k) a change of the biological or chemical principle of the test.

The list functions as a pre-screening gate: any change proposal that touches one of these items leaves the change-management system entirely and enters the new application pathway, with the associated fees, review timeline and documentation requirements of a first submission rather than a variation.

2. Legal basis

3. Expert insights

Insight 1: Item (a) interacts with Article 5(2) of GN 315 – once the classification changes, the product is no longer the same product.

Article 5(2) provides that where multiple rules apply, the highest risk class is taken; §4(a) provides that a change of classification cannot proceed as a change. Combined, this means that any factor capable of changing the applicable rule – a new indication, a new measurement function, a switch to sterile supply – triggers both a re-classification and the requirement to file a new application. This also explains why the three features highlighted for Class A devices matter: they are both pathway boundaries and classification boundaries at the same time.

Insight 2: Items (c), (d), (e) and (k) together define the product identity boundary of an IVD.

The approved intended use (c), the analyte or measurand (d), the antigens, antibodies, primers or solid phase (e) and the biological or chemical principle (k) – a change to any of these means the IVD is no longer the same product. This contrasts with §5.8 (the material changes of Decision Tree G): a material change that does not alter the working principle and requires no additional clinical samples can be a major change or may not even be triggered, whereas a change of principle, analyte or core reaction components leads directly to a new application.

Insight 3: The qualitative-to-quantitative switch in item (j) catches many companies by surprise.

Upgrading a rapid test from qualitative (negative/positive) to quantitative (reporting concentration values) looks like a performance enhancement, but in Tanzania it is a new product. Likewise, item (b) covers a change to the specific disease, condition or risk factor that an IVD is intended to detect – adding a disease target is not an extension of the indication but a new application, because the identity of the assay, not merely its performance, has changed.

Insight 4: Items (h) and (i) turn grouping and brand management into hard boundaries.

Under item (h), new models that do not meet the family/accessory pack/group definitions cannot be added by change; under item (i), devices under a different brand name cannot be added either. Together these mean that product line extension cannot be accumulated through changes. The grouping strategy chosen at first registration directly determines what can be added later. A grouping chosen too narrow leads to more application fees; one chosen too wide is constrained by the grouping criteria – the grouping decision is a one-off strategic choice.

Insight 5: Items (f) and (g) target combination products, consistent with the principle that drug-device combinations remain high risk.

A change to the active pharmaceutical ingredient combined with a registered device (f) and a change to a registrable drug in an auxiliary role (g) both address the boundary between device and drug – once the drug component changes, the characterisation of the product changes with it. This is consistent with the approach of the 2024 Compendium, Part XI, on the determination of borderline products, and reinforces that drug-related content is never treated as a minor variation.

4. Practical recommendations

1. Build the 11 items into a change pre-screening checklist; every change proposal passes the negative list first.
2. Route anything on the list into a new application; do not attempt to split it into several small changes to circumvent the rule.
3. For IVD projects, self-check items (b), (c), (d), (e), (j) and (k) with priority – these six are IVD-specific and lie exactly where product iteration happens most often.
4. Fix the grouping strategy at first registration (items (h) and (i)).
5. Keep a separate register for combination products: a change of drug component means a new application (items (f) and (g)).
6. Make classification re-assessment routine: every change proposal re-runs the classification rules (Article 5(2)).

5. Verification checklist

• □ The change proposal has passed the 11-item negative list pre-screen of §4.
• □ Items falling on the list have been set up as a new application (not a change).
• □ IVD projects have prioritised the self-check on items (b), (c), (d), (e), (j) and (k).
• □ Grouping and brand strategy were fixed at first registration (items (h) and (i)).
• □ Drug component changes in combination products are tracked separately (items (f) and (g)).
• □ Every change proposal has re-run the classification rules (Article 5(2)).
• □ Awareness that a change of classification falls under §4(a) and can only be handled by a new application.

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 §4(a)–(k), §5.8; GN. No. 315, Articles 5(2), 13(2) and 23; the June 2024 Compendium, Part I §3.1 and Part IX); 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.
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