Tanzania medical device regulations
Official sources linkedTMDA rules and guidance for medical device market access, registration, and lifecycle compliance. Each code opens a metadata page with the official source and readable HTML when available.
| Code | Regulation | Category | Effective | Provenance |
|---|---|---|---|---|
| Medical Device and In Vitro Diagnostic Devices Regulations | Medical Device and IVD Regulations TMDA regulations governing registration, control, and oversight of medical devices and in vitro diagnostic devices under the Tanzania Medicines and Medical Devices Act. | Registration | — | Official |
| Tanzania Medicines and Medical Devices Act, Cap. 219 | Tanzania Medicines and Medical Devices Act Primary statutory basis for TMDA regulation of medicines, medical devices and diagnostics. This entry points to the official acts collection. The proposed Chapter 219 R.E. 2021 PDF carries a REVIEW DRAFT watermark and is not published as the authoritative consolidated text. | General | — | Official |
| TMDA/DMD/MDA/G/001 Rev 03 | Compendium of Guidelines for Marketing Authorization of Medical Devices, Diagnostics and Laboratory Equipment TMDA marketing-authorization compendium (June 2024, document # TMDA/DMD/MDA/G/001 Rev 03, 247 pages) — the official successor to the standalone "Guidelines on Submission of Documentation for Registration of Medical Devices" (TMDA/DMC/MDC/G/001, 3rd edition April 2020), whose stored TMDA upload URL now returns HTTP 404 while TMDA's marketing-authorization procedure page links this compendium alongside the dead file. Consolidates the dossier guideline family into Parts I-XI — procedural aspects for marketing authorization, technical documentation requirements for medical devices and IVDs, notification of exempted devices, classification rules for devices and IVDDs, clinical evidence, labelling incl. electronic IFU, grouping, software and AI medical devices, borderline products — plus Annex I essential-requirements checklist, Annex II essential-principles guidance, and Annex III ISO 15223-1 symbols. Ingested in full with all parts and annexes. | Registration | — | Official |
Exports carry source + retrieval dateWhat these codes are
Each row above represents one regulatory instrument. Its code is the authority’s identifier. A regulation page collects the metadata and official source; when readable HTML is available, article links can open and highlight the exact cited passage.
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