Tanzania Queries and the 60 Working Day Deemed Withdrawal Rule

1. Key takeaways

The query rules in Tanzania contain two independent consequences that companies routinely conflate:

1. Query → clock halt → no response within 60 working days deemed withdrawal. Part I §3.4.6 of the June 2024 Compendium: once a query is raised, the processing halts until the response is received (“the processing shall halt”); if no response to the query or request is received within 60 working days, it will be deemed that the application has been withdrawn by the applicant.
2. Wrong route → outright rejection and return. Part I §3.4.2: where a notification application is lodged for a product outside the notification scope, the application is rejected and returned without a query.

The consequences differ sharply: a query is a pause with a rescue path, while rejection and return means starting over. Project plans, internal alerts and client reporting should treat the two events with completely different escalation levels, because the recovery cost of a deemed withdrawal — re-lodging, re-paying, re-queuing — is far higher than the cost of answering a query on time.

2. Legal basis

3. Expert insights

Insight 1: Section 15 of GN 315 writes failure to respond on time directly into the grounds for refusal.

Section 15(1)(d): where an applicant fails to submit additional information or samples by a specified date in response to a requirement made by TMDA under these Regulations, TMDA may refuse to issue or vary a registration. Section 15(2): refusal is also available where the device does not meet the requirements as to safety and performance, or where the information or samples submitted are insufficient to enable TMDA to determine whether the device meets them. Section 15(3): a refusal must be notified in writing with reasons, and the applicant must be given the opportunity to make representations to TMDA. This is the procedural safeguard clause, and knowing it exists changes how applicants should document every exchange with the authority.

Insight 2: Section 12 gives TMDA two query powers, covering both the application stage and the examination stage.

Section 12(1): where the information is insufficient to determine whether the device meets the requirements as to safety and performance, TMDA may require the applicant to submit additional information by a specified date. Section 12(2): in examining an application, TMDA may require the applicant to submit additional information or device samples. The heading of Section 12 is “Additional Information and Samples”, and the section applies to both registration applications and variation applications (“in respect of an application for registration of a medical device or variation of a medical device registration”). Variation projects therefore face the same halt-and-withdraw dynamics as new registrations.

Insight 3: The 60 working days produce a deemed withdrawal, not a rejection.

The wording has practical weight: deemed withdrawal means the application no longer subsists, but no negative decision has been issued; a refusal under Section 15 leaves an adverse record and engages the representations procedure. In practice, if a response within 60 working days is genuinely impossible, proactive communication beats silence — although the official text sets out no statutory procedure for extending the deadline, GRZAN recommends explaining the situation to TMDA in writing, requesting confirmation, and retaining all correspondence as evidence of engagement.

Insight 4: The screening stage already filters out two categories of problems before any query is raised.

§3.4.2 defines two exits at screening: incomplete applications are queried and returned for correction; notification applications for the wrong route are rejected and returned. Route-selection errors are thus intercepted before formal assessment begins. This is the reason article 05 stresses the reading that satisfying any single characteristic requires registration: the cost of a wrong route choice is not a query round but a full restart of the application.

4. Practical recommendations

1. Set 60 working days as the internal red alert line, and start a countdown ledger on the day the query is received.
2. Aim for a complete, one-pass query response. Multiple query rounds repeatedly trigger the clock halt, and the project timeline never converges.
3. When a timely response is impossible, explain in writing and request confirmation — do not wait silently; the statutory consequence of silence is deemed withdrawal.
4. Self-check the route before submission to avoid a notification application being rejected and returned under §3.4.2.
5. Keep replacement samples in stock; Section 12(2) allows TMDA to demand additional samples during examination, and producing samples from scratch consumes most of the 60 working days.

5. Verification checklist

• □ A query countdown ledger is in place, with the alert line at 60 working days.
• □ The response has been confirmed to be submitted complete in one pass, avoiding multiple rounds.
• □ The submission route has been confirmed correct and outside the rejection-and-return scenario of §3.4.2.
• □ Samples available for additional submission are in stock (Section 12(2)).
• □ The procedural right to make representations under Section 15(3) of GN 315 is known to the project team.

Regulatory information verified as of 29 October 2026. All provisions cited in this article were checked against the texts officially published by TMDA (June 2024 Compendium Part I §3.4.2 and §3.4.6; GN. No. 315 Sections 12 and 15); the content is re-reviewed whenever the regulations are updated.

• Local resources in Tanzania: GRZAN can coordinate licensed local responsible persons (LRP) and distributor resources covering online submission, sample delivery, quality audit support and port clearance.
• Service capabilities: classification determination, route selection between registration and notification, technical documentation (CSDT/STED) preparation and localization, GMDN coding 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.