Tanzania medical device registration timeline

Source-linked clocks

Tanzania Medicines and Medical Devices Authority (TMDA) review clocks and end-to-end planning ranges, using the 4-class (A, B, C, D) — EU-aligned classification system.

4 pathways4 of 4 clocks verifiedvalidity 5 yearsMDSAP not acceptedreviewed 2026-08-25

Class / pathway	Review clock	Planning total	With prior approval	Provenance
Class A(TMDA registration) Compendium of service standards: 20-45 working days end-to-end (screening 1-2, scheduling 10-20, assessment 23-40, QA 5-8, admin 5-25)	20-45 working days	2-4 months	—	Verified
Class B(TMDA registration) Compendium of service standards: 20-45 working days end-to-end (screening 1-2, scheduling 10-20, assessment 23-40, QA 5-8, admin 5-25)	20-45 working days	2-5 months	—	Verified
Class C(TMDA registration) Compendium of service standards: up to 45 working days end-to-end (screening 1-2, scheduling 10-20, assessment 23-40, QA 5-8, admin 5-25)	45 working days	3-6 months	—	Verified
Class D(TMDA registration) Compendium of service standards: up to 45 working days end-to-end (screening 1-2, scheduling 10-20, assessment 23-40, QA 5-8, admin 5-25)	45 working days	4-8 months	—	Verified

Review clocks exclude applicant hold time · planning totals are estimates

Tanzania Medical Device Registration Process

Step-by-step TMDA registration process. Total estimated timeline: 2-4 months.

Step 1: Pre-Submission Preparation

1-3 months

Gather technical documentation, quality management system (QMS) records, and clinical data required by TMDA. Appoint a Tanzanian Authorized Representative.

Step 2: Application Submission

1-2 weeks

Submit complete registration dossier to TMDA including device description, risk analysis, and testing reports.

Step 3: Administrative Review

2-4 weeks

TMDA reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

20-45 working days

In-depth technical assessment of device safety and performance. TMDA may issue questions.

Step 5: Registration Approval

1-2 weeks

Upon successful review, TMDA issues Tanzania market authorization certificate.

Summary: The Tanzania medical device registration process through Tanzania Medicines and Medical Devices Authority (TMDA) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.

Prior approval recognition

CE Mark (EU MDR)Technical documentation and QMS evidence reuse1-3 months

FDA 510(k)/PMASubmission content reuse as reference evidence

Key requirements

Local Authorized Representative required for foreign manufacturers
Screening-to-notification stages: screening 1-2 wd, scheduling 10-20 wd, assessment 23-40 wd, QA 5-8 wd, admin 5-25 wd
Registration certificate notification within 5 working days of decision; variations decided within 10 days

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Source-linked review clocks verified against TMDA publications · full review 2026-08-25 · row IDs are stable — cite as registration-timeline:tanzania:class-a