Quality Audit Scope for Medical Device Manufacturing Sites in Tanzania

1. Key takeaways

Tanzania applies a separate gate for manufacturing sites — the Quality Audit. TMDA’s Guidelines on Submission of Documentation for Quality Audit of Medical Devices and Diagnostics Manufacturing Sites define the scope of application as follows:

§7.1.1: the quality audit applies to sites manufacturing Class C and Class D medical devices and diagnostics, as well as sites manufacturing Class A and Class B invasive and/or sterile products. Audits of Class A and Class B (non-invasive, non-sterile) sites are determined at the time of the marketing authorization review, depending on product risk.

The audit is conducted against the good manufacturing practice (GMP) requirements contained in the ISO 13485 quality management system standard. Once the site passes, a quality audit certificate valid for 3 years is issued (§9.4), and it may be renewed in accordance with the prescribed procedure. The certificate is site-based, not product-based, which means its lifecycle must be managed separately from the product registration itself.

2. Legal basis

3. Expert insights

Insight 1: Class A/B sites are not exempt across the board — the trigger is the two words invasive and/or sterile.

The wording of §7.1.1 is “class A, B invasive and/or sterile products”. Note the and/or: invasiveness alone triggers the audit, and sterility alone triggers it as well. A sterile syringe (Class B) and an invasive catheter (Class B) both go through the quality audit, whereas an ordinary tongue depressor (Class A) generally does not. GRZAN still performs a dedicated trigger assessment on every Class A/B project, because the classification outcome alone does not answer the question.

Insight 2: The audit scope, the number and qualifications of auditors, and the audit duration are all determined by risk grading.

§7.1.2: TMDA evaluates the application and the accompanying documents and performs a risk assessment; the preliminary evaluation findings and the risk category are used to determine the audit scope, the number and qualifications of auditors, and the number of audit days required. Based on perceived risk, TMDA may also determine whether the site requires an on-site audit or may proceed by desk review. This means that the audit intensity for the same company can differ across product lines, and the outcome cannot be assumed from a previous audit of another product family.

Insight 3: Non-conformities are graded into three levels, and the handling differs completely.

§8: non-conformities are classified as critical, major or minor. The handling rules in §9 are:

• §9.1 Where a critical non-conformity exists, the site must take corrective action and re-apply for an audit as prescribed (re-audit);
• §9.2 Where a major non-conformity exists, the site must take corrective action and submit a compliance report within the timeline set by TMDA (including corrections already implemented and corrective actions to be taken);
• §9.3 For sites assessed through desk review, where a critical or major non-conformity is suspected, the process converts to an on-site audit; where the non-conformity is major or minor, the site can only be found compliant after responding to the query;
• §9.4 Once the requirements are met, the certificate is issued with a validity of 3 years.

Insight 4: Inadequate QMS and GMP is itself a ground for losing the certificate, regardless of whether the product itself is compliant.

Regulation 18(f) of GN 315: based on information obtained after registration, if the QMS and GMP on which the design of Class C and Class D devices is based, or the QMS and GMP on which the manufacture, assembly, processing, packaging, refurbishment or modification of Class B, C and D devices is based, are insufficient to ensure that the device conforms to its specification, TMDA may suspend or cancel the registration. This elevates a manufacturing system deficiency directly into a product licensing problem.

Insight 5: The quality audit certificate is valid for 3 years and is not synchronized with the 5-year registration.

The 3-year validity of the quality audit certificate under §9.4 and the 5-year registration validity under regulation 17(1) of GN 315 are two independent cycles. A company needs to renew the quality audit certificate in year 3 and renew the product registration in year 5 — the two lines must be scheduled separately, with the audit renewal falling roughly in the middle of the registration term.

4. Practical recommendations

1. Start quality audit preparation in parallel with any Class C/D project; do not wait until the dossier review is halfway done.
2. For Class A/B, perform the invasive/sterile trigger assessment first and record the outcome in the project memorandum.
3. Aim for desk review (see article 13 for details), but prepare an on-site audit plan B at the same time — §9.3 provides that desk review converts to on-site audit as soon as a critical or major non-conformity is suspected.
4. Maintain two independent calendars — one for the quality audit certificate (3 years) and one for the product registration (5 years) — to avoid missed renewals.
5. Ensure the ISO 13485 certificate is issued by a recognized conformity assessment body (CAB) (the parallel requirement for notification applications in Part IV §3.2.3 can be used as a reference).

5. Verification checklist

• □ Product class and invasive/sterile characteristics assessed, and whether the quality audit is triggered confirmed.
• □ Manufacturing site holds a current ISO 13485 certificate issued by a recognized CAB.
• □ Desk review versus on-site audit evaluated, with both options prepared.
• □ Consequences of the three non-conformity grades (critical/major/minor) understood.
• □ Dual calendar established for the quality audit certificate (3 years) and the product registration (5 years).

Regulatory information verified as of 29 October 2026. All provisions cited in this document were checked against the official published texts of TMDA (the quality audit guidelines §7.1.1, §7.1.2, §8, §9.1–§9.4; the June 2024 Compendium of Guidelines, Part I §3.4.5; GN. No. 315, regulation 18(f)), 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.
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