Register Medicines And Medical Devices In Tanzania
How do I register a medicine or medical device for Tanzania? Tanzania Medicines and Medical Devices Authority (TMDA) is the competent authority for registering medicines and medical devices before they are placed on the Tanzanian market. Company registration is not product registration. Confirm the live TMDA guidelines for that product type (human medicine, device class, diagnostics). This page does not list evaluation fees. Product registration sits beside the company’s business licence, not instead of it.
TMDA registers the product. A clinic licence registers the premises. They are not interchangeable. Mainland-first, 19 August 2026. Confirm the live TMDA class for the medicine or device before you ship a sample pack as stock.
The gain is product-vs-premises: TMDA product file plus any import/wholesale premises licences. If a sentence here disagrees with the live portal, the portal wins. Fees, forms, classes and processing times change. This page does not reprint a fee table that will be wrong after the next notice.
What this page decides
This page decides TMDA product registration. It is not a hospital licence.
Fix four things before you open a portal for registering medicines and medical devices in Tanzania: the activity in plain language, who owns it, whether the work happens on the mainland or in Zanzibar, and classify the product. Here the first of those is classify the product. While any of those is still moving, every instrument issued against them will have to be restated.
Competent institutions (verify live)
| Institution | What it actually controls | What it does not replace |
|---|---|---|
| TMDA | Product registration and many premises classes | BRELA |
| TRA/Customs | Import of registered products | The dossier |
Typical sequence
Use the order to sequence work, not to promise a date. What drives elapsed time on registering medicines and medical devices in Tanzania is the quality of the file, not the number of steps.
- Classify the product: Medicine vs device vs borderline food/supplement.
- Identify local responsible party: TMDA processes usually need a local applicant/agent as the live rules require.
- File the dossier on the live pathway: Do not use another country’s approval as automatic Tanzania registration.
- Then import/wholesale licences if you will import: Product approval ≠ importer class.
Documents the file usually needs
Packs for registering medicines and medical devices in Tanzania differ by class and by form revision. The list is orientation; the exact fields follow TMDA on the day you file.
- Dossier the guideline lists
- GMP/QMS evidence as required
- Local company/agent particulars
Mainland vs Zanzibar
Confirm whether island supply needs extra steps. TMDA is the usual Union medicines authority: verify current practice.
Common mistakes, delays and repairs
- Selling on a Kenya registration
- Importing ‘samples’ at commercial scale
- Calling a device a wellness gadget to skip class
What this process does not include
- Clinical-trial design
- A fee table
Verify before you file
Open the TMDA portal on the day you file. This page explains how registering medicines and medical devices in Tanzania works; the mapped service page is the commercial desk. Zatra does not issue licences, tax clearances or permits, and live regulator, bank and immigration rules govern.
Frequently asked questions
Does CE/FDA approval replace TMDA?
No. They may support a dossier. TMDA decides Tanzania registration.
Can I import before registration?
Generally no for commercial supply. Confirm any named exemptions on TMDA.
Does this TMDA page quote product-registration fees?
No. Confirm TMDA’s live schedule for that product class. TBS is a different mark.
Who must be the applicant?
Confirm the live guideline, often a local responsible person/company.
Supplements?
Borderline products may sit with TMDA or other food regulators. Classify honestly.
Does a hospital licence register the drug?
No. Facility licensing and TMDA product registration are separate files.
Disclaimer
This article is provided for informational purposes only and does not constitute legal, tax or investment advice. Tanzanian medicines and medical-device regulation may change through legislative amendment, regulation or administrative directive. The position stated here is read from material published by TMDA and TRA, and those authorities may change it without notice. Investors should obtain professional advice on their own facts before relying on a licence class, permit route or compliance deadline. Zatra Consultants Limited does not issue licences, permits, tax clearances or approvals, and gives no assurance of any regulatory outcome.
Sources & regulators
Verify before filing: Fees, forms and timelines change. Confirm the current schedule on the linked regulator portal before you budget or submit.
- Tanzania Medicines and Medical Devices Authority (TMDA): Medicines, medical devices and related product registration. Accessed 2026-08-16.
- Tanzania Revenue Authority (TRA): TIN, VAT, withholding, customs and tax administration. Confirm live steps and Finance Act text. Accessed 2026-08-16.
- Business Registrations and Licensing Agency (BRELA): Mainland companies, business names, beneficial ownership and related filings. Confirm live ORS forms. Accessed 2026-08-16.
See BRELA company registration support for the live desk route.