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TMDA · structured requirements

🇹🇿 Tanzania medical device regulatory data

Explore the medical device requirements currently available for Tanzania, organized by topic and linked to official sources.

2 facts2 dimensions2 official sourceslatest verification 2026-08-24

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

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Authorization duration

authorization.duration
Official document
Type

Route Dependent

Description

Full registration is valid 5 years; notification is valid 3 years.

Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

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Label, IFU, and submission language

language.label-ifu-submission
Official document
Label Ifu

English and/or Kiswahili; Kiswahili required for home-use instructions/labels under cited compendium

Submission

English

Status

Verified Official

Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.

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