Premises Permits for Medical Device Businesses in Tanzania

1. Key takeaways

Tanzania separates the product track from the establishment track. Regulation 24 provides that no person shall manufacture, import or supply any device for sale unless the device is registered, the person holds a valid premises permit issued by TMDA, and the activities are conducted in accordance with the conditions of the permit. Registration of the product and authorization of the establishment are therefore two independent gates that must both be open before commerce begins.

The core rules of the premises permit:

2. Legal basis

3. Expert insights

Insight one: the Regulation 31 application pack contains two declarations by the person in charge, which are the statutory precondition for written procedures.

Regulation 31(1) requires the application to include: (a) the name and address of the owner; (b) the name and physical address of the premises; (c) the name, e-mail address and telephone number of the contact person; (d) a statement whether the premises conduct manufacturing or importing; (e) an attestation by the person in charge of the premises that written procedures have been established for distribution records, complaint handling, recalls and mandatory problem reporting; and (f) an attestation by the person in charge that written procedures have been established for handling, storage, delivery, installation, corrective action and servicing, where applicable.

Items (e) and (f) are attestation-type requirements — the procedures themselves are not filed, but the person in charge confirms they exist. Since an attestation is made, the procedure documents must genuinely exist and must be available for inspection at any time.

Insight two: Regulation 33 lists retail and wholesale separately, which means retail also needs a permit.

Regulation 33 provides that any person intending to carry on the retail or wholesale business of medical devices must apply to TMDA. Combined with the prohibition in Regulation 30 on operating without a permit, the device supply chain in Tanzania is licensed end to end: manufacturing, importing, distribution, wholesaling and retailing each require the corresponding authorization.

Insight three: of the three refusal grounds in Regulation 34, the third is failing to meet the minimum requirements for registration of premises.

Regulation 34(1): (a) the applicant has made a false or misleading statement; (b) TMDA has reasonable grounds to believe that issuing the permit would constitute a risk to the health or safety of patients, users or other persons; or (c) the applicant has not met the minimum requirements for registration of premises. Regulation 34(2) requires that a refusal be given in writing with reasons and that the applicant be given an opportunity of being heard.

Insight four: the suspension procedure embeds three procedural safeguards, mirroring the suspension of product registration under Regulation 20.

Regulation 36(3): TMDA shall not cancel or suspend a premises permit unless it has issued a 14-day written notice stating the reasons for the intended suspension, any corrective measures required and the period; the corrective period stated in the notice (where required) has expired without action; and the permit holder has been given an opportunity to make representations on the suspension. Regulation 36(2) additionally requires TMDA, before cancelling or suspending, to consider whether maintaining the permit in force would endanger health or safety.

Insight five: the distribution record duty covers five categories of actors, and its purpose is complete and rapid withdrawal from the market.

Regulation 39(1): manufacturers, importers, distributors, health care facilities and retailers must each keep distribution records for every device. Regulation 39(2): distribution, sale and user records must contain traceability information sufficient to support the complete and rapid withdrawal of devices from the market in the event of a recall or for any other reason. Regulation 40 (retention): records must be kept for the expected lifetime of the device and for 2 years after shipment of the device, and must be retrievable in a timely manner.

4. Practical recommendations

1. Treat 30 June as the fixed annual milestone for the premises permit and start renewal 90 days in advance.
2. Build an internal trigger for the 21-day change notification: any change to the owner details, premises address, contact person, or activity type (manufacturing or importing) starts the clock.
3. Back the two attestations of Regulation 31(1)(e) and (f) with real procedure documents that can be produced for inspection at any time.
4. Design distribution record fields to the complete-and-rapid-withdrawal standard of Regulation 39(2), retained for the expected lifetime plus 2 years after shipment.
5. On receiving a 14-day suspension notice, start corrective action immediately; once the period lapses without action, the hearing and suspension process follows.

5. Verification checklist

• □ A valid premises permit issued by TMDA has been obtained and is held (Regulation 30).
• □ The expiry date of the permit is on record: 30 June each year (Regulation 32(2)).
• □ The application pack contains all six items of Regulation 31(1), including the two attestations.
• □ Retail and wholesale businesses have applied separately (Regulation 33).
• □ A 21-day change notification mechanism is in place (Regulation 35).
• □ It is understood that suspension requires 14 days written notice and that reinstatement takes 30 days (Regulation 36(3)(a) and Regulation 38).
• □ Distribution records are designed to the complete-and-rapid-withdrawal standard, retained for the expected lifetime plus 2 years after shipment.

Regulatory information verified as of 29 October 2026. All provisions cited in this document were checked against the official TMDA published texts (GN. No. 315, Regulations 24 and 30–40; the June 2024 Compendium Part I §2.2) and will be re-reviewed when the regulations are updated.

• Local resources in Tanzania: GRZAN can coordinate a licensed Local Responsible Person (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-enabled device submissions, change management, vigilance and PMS reporting, and annual retention fee and renewal management.
• Contact GRZAN for registration documentation and conformity support for the Tanzania market: info@grzanglobal.com.