Tanzania Medical Device Regulator TMDA and the Cap. 219 Legal Mandate

1. Key takeaways

Marketing approval authority for medical devices and in vitro diagnostic devices (IVDDs) in Mainland Tanzania rests with the Tanzania Medicines and Medical Devices Authority (TMDA). TMDA states explicitly on its official website that it authorizes the placement of medical devices (MD) and diagnostic devices (IVDDs) on the market under Section 51 of the Tanzania Medicines and Medical Devices Act. For any manufacturer planning entry into the Tanzanian market, this single sentence defines who decides, under which statutory power, and why every downstream requirement in the device regime traces back to one parent statute.

The legal architecture supporting the entire device regime has only two layers, yet the two layers differ in age by more than sixty years in regulatory lineage, and the distinction matters in practice:

• Parent statute: the Tanzania Food, Drugs and Cosmetics Act (Cap. 219), enacted in 2003 and later renamed the Tanzania Medicines and Medical Devices Act. The current name change followed an institutional reform in which the former Tanzania Food and Drugs Authority (TFDA) was reorganized into TMDA.
• Subsidiary legislation: the (Control of Medical Devices) Regulations, 2015, made under Section 122(1)(c)(e) of Cap. 219, published as Government Notice No. 315 (GN. No. 315) on 31 July 2015.

GRZAN highlights one easily overlooked fact: the formal title of GN 315 still reads “Tanzania Food, Drugs and Cosmetics (Control of Medical Devices) Regulations, 2015”, because the parent statute had not yet been renamed when the regulations were made. The TMDA website refers to the same document under both the old and the new name in its regulatory listings. If you cite strictly by title, an apparent contradiction with the current authority name arises — this is an artifact of legislative history, not evidence of two different regulations. Understanding this point prevents needless confusion in official correspondence with TMDA, in dossiers, and in tender documents where regulators or procurement bodies may quote either name.

2. Legal basis

3. Expert insights

Insight 1: Section 122(1)(c)(e) is the authorization interface for the entire device rulebook and defines the limits of GN 315.

The first page of GN 315 states expressly that it is made under Section 122(1)c)(e). This means no provision of GN 315 may exceed the scope of the parent statute; where a regulatory requirement conflicts with the Act, the Act prevails. The practical consequence for manufacturers is this: where GN 315 is silent on a situation, you cannot presume that silence equals no restriction. You must return to Cap. 219 and to TMDA’s statutory duties to judge the obligation. This interpretive discipline protects applicants from building submission strategies on assumptions that a later review can dismantle.

Insight 2: TMDA is simultaneously the review authority and the enforcement authority.

Cap. 219 and GN 315 place registration and approval (Sections 13, 14, 15), premises licensing (Sections 30–38), import and export permits (Sections 45–47), port inspection (Sections 56–58), vigilance reporting (Sections 41–44), recalls (Sections 63–66), advertising (Sections 68–73) and penalties (Sections 76, 77) in the hands of the same institution. Unlike systems that separate approval from market surveillance, a single violation record can affect both applications under review and products already licensed. GRZAN therefore manages in-review and on-market compliance ledgers as one combined account in project governance, so that any enforcement signal is visible to the team handling ongoing submissions.

Insight 3: GN 315 contains 78 sections and five schedules, a coverage far broader than most emerging markets.

The sections are organized into ten parts: Part I preliminaries (Sections 1–3); Part II classification (Sections 4–5); Part III registration (Sections 6–27); Part IV licensing of premises for device businesses (Sections 28–43); Part V import and export (Sections 44–58); Part VI disposal of non-conforming devices (Sections 59–62); Part VII recalls (Sections 63–66); Part VIII advertising (Sections 67–72); Part IX labelling (Sections 73–75); Part X general provisions (Sections 76–78). Note: the official PDF contains one misalignment between headings and text — the table of contents lists “Labelling” as Section 73 and “Restriction on labeling” as Section 74, whereas in the body Section 73 is “Comparison of Products”, Section 74 carries the eleven labelling requirements, and Section 75 is the language requirement. When citing, follow the body text: labelling requirements sit in Section 74 and language requirements in Section 75.

Insight 4: The scope of application is limited to Mainland Tanzania.

Several provisions of GN 315 use the expression “Mainland Tanzania” (for example Section 42(1)(a)(i) on domestic events, and Section 42(1)(b) on matters “outside Mainland Tanzania”). Zanzibar maintains its own arrangements for medicines and devices. GRZAN consistently defines Tanzania projects as Mainland only in quotations and proposals, to avoid any implied inclusion of Zanzibar institutions in scope, budgets or responsibility allocations. Manufacturers targeting Zanzibar must confirm the applicable requirements separately.

4. Practical recommendations

1. Cite regulations with all three elements: name + GN. No. 315 + section number. Abbreviating to “the 2015 Regulations” is acceptable in internal communication, but formal correspondence to TMDA must be complete.
2. Build a three-tier citation habit: parent statute — regulations — guidance. When communicating with TMDA, cite the regulation section first, then the guidance chapter. Guidance cannot serve as an independent source of obligation; it only explains compliance methods.
3. Do not treat TFDA-era documents as current authority. Device-related documents issued by TFDA before 2015 that TMDA has not expressly carried forward should not be used as a basis for submissions.
4. For disputes involving labelling, advertising or recalls, go directly to the specific GN 315 provisions rather than industry custom. The eleven items in Section 74, the comparison prohibition in Section 73, and the recall timelines in Section 66(2) are hard requirements.

5. Verification checklist

• □ Confirm the target market is Mainland Tanzania; Zanzibar requires separate confirmation.
• □ Confirm the current parent statute is cited as the Tanzania Medicines and Medical Devices Act, Cap. 219.
• □ Confirm the subsidiary legislation cited is GN. No. 315, published on 31 July 2015.
• □ When citing labelling provisions, use Section 74 (eleven items) and Section 75 (language), not the numbers shown in the table of contents.
• □ Confirm the TMDA website page “Procedures for Marketing Authorization” is consistent with this article (Section 51 authorization).
• □ A three-tier citation ledger (statute — regulations — guidance) has been established.

Regulatory information verified as of 29 October 2026. All provisions cited in this article were checked against the texts officially published by TMDA (Cap. 219, GN. No. 315, and the June 2024 Compendium of Guidelines); 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.