Explore the medical device requirements currently available for Tanzania, organized by topic and linked to official sources.
What expires, what is retained periodically, and when must renewal start?
Registration of a medical device is valid for five (5) years and notification approval for three (3) years, unless suspended or revoked by TMDA or terminated by the registrant.
Applications for renewal of registration must be made at least 90 days before expiry of the existing registration, with a summary of all changes (approved and pending), specifications with batch certificates of analysis, label artwork and IFU, post-marketing surveillance reports and two samples from the same batch.
Continued validity of registration is subject to payment of annual retention fees as prescribed in the current Fees and Charges Regulations in force.
The registrant may terminate marketing authorization of a device by giving TMDA 60 days written notice and reasons; TMDA may for stated reasons suspend or revoke the registration or amend its conditions.
Which label and IFU elements, languages, symbols, and translation controls apply?
Labels and instructions for use for products marketed in Tanzania must be in English and/or Kiswahili; Kiswahili is required for home-use medical devices; other languages may be used as necessary. Applications and supporting documents may be in Kiswahili or English.
Use of Kiswahili is required for home-use medical devices (labels and IFU).
e-IFU is eligible only for devices limited to professional users; users must always be able to obtain the content in paper form on request, without undue delay or within the risk-assessment period, at no additional cost; the web address must be printed on the physical label. Paper-form IFU is required for home-use devices (electronic additional IFU optional).
Any TMDA logo is prohibited on medical device labelling; statements naming TMDA or the Ministry of Health Tanzania are prohibited in all labelling unless required by the Ministry (considered Authority endorsement).
Manufacturers of implantable devices must supply an implant card and patient information including device name, serial number, lot number, UDI and device model plus manufacturer name/address/website, stated in Kiswahili and English, readily understandable by lay persons and updated via the website; health institutions must give it to implanted patients with the card bearing their identity. Sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors are exempt.
Which current law, regulation, guidance, and transition provisions apply?
Principal legislation: The Tanzania Medicines and Medical Devices Act, Chapter 219, Revised Edition 2023 (principal legislation; renamed and amended by Act No. 8 of 2019).
Device classification and control rest on the TMDA (Control of Medical Devices) Regulations, GN No. 315 of 2015, as cited in the official compendium.
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Applications for marketing authorization of medical devices, diagnostics and laboratory equipment are assessed under the Compendium of Guidelines, TMDA/DMD/MDA/G/001 Rev 03, June 2024.
Notification applications must follow the Guidelines on Applications for Notification of Medical Devices and In Vitro Diagnostic Devices, 1st Edition 2022, effective 1 August 2022, covering devices exempted from registration, veterinary devices and medical gases.
Application fees are those specified in the Fees and Charges Regulations in force at the time of application; TMDA's fees page cites 'The Tanzania Medicines and Medical Devices (Fees and Charges) Regulation, 2022' and links a GN No. 686 PDF.
Is the product a device, IVD, accessory, software, or borderline product locally?
Cap. 219 defines 'medical device' broadly - any instrument, apparatus, laboratory equipment and reagent, implement, machine, appliance, implant, in vitro reagent, or calibrator, software, material or other similar or related article intended by the manufacturer to be used, alone or in combination, for human beings or other animals.
IVD medical device: a device intended by the manufacturer for the in vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes, including reagents, calibrators, control materials, specimen receptacles, software and related instruments.
Standalone software (SaMD in IMDRF context) is regulated: a software and/or mobile application intended to function by itself and not intended to control or affect the operation of other hardware medical devices; the compendium has a dedicated software guideline (Part X).
Accessories are classified in their own right as medical devices and do not necessarily take the classification of the device with which they are intended to be used; a product is an accessory only if it has an established intended use in conjunction with a medical device.
Medical gases (e.g. oxygen, nitrous oxide, medical air, carbon dioxide, helium) are regulated as medical devices through the notification route; applications must include controlled copies of valid SOPs/protocols for production including storage procedures.
Used products refurbished by a third party that is not the original manufacturer: that third party bears the responsibility of the manufacturer under the guideline.
The compendium addresses borderline determination: where a product has features similar to medicines, cosmetics, food supplements or biocides, device status may be difficult to determine and is assessed case by case (dedicated borderline manual, Part XI).
Which registration, notification, listing, reliance, or conformity route applies?
Registration is the main route and applies to all class B, C and D medical devices and IVDs plus class A devices that are active, have a measuring function, or are sterile; notification is reserved for other class A devices and IVDs that do not meet the registration criteria.
Each application must contain exactly one of: a single medical device, one medical device family, one medical device system, or one medical device group; family members must share product owner, risk classification, intended purpose, design and manufacturing process, with variations within permissible variants.
Which foreign decisions or evidence can be reused, with what effect and conditions?
WHO-prequalified IVDs can be registered via the WHO collaborative registration procedure: applicant submits the same dossier to TMDA as the one approved by WHO for prequalification and authorizes WHO to share its assessment and inspection outcomes with TMDA; TMDA online submission and fees still apply.
Confirms the Mainland Tanzania edge of the WHO PQ -> CRP reliance path.
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
The applicant must be a Tanzania resident licensed by TMDA as a medical device dealer; a non-resident applicant must appoint a Local Responsible Person (LRP, also called Authorized Representative or Local Agent) - a company incorporated in Tanzania and authorized by TMDA to deal in medical devices - with proof of official appointment submitted during the marketing authorization process.
Which establishment licences, importer permissions, and distribution controls apply?
No person other than a holder of a licence or permit under Cap. 219 may import or export into Mainland Tanzania any drugs, medical devices, herbal drugs or poisons.
Importers and exporters must register their premises with TMDA before applying for import/export permits; the Act separately prohibits manufacture for sale, sale, supply or storage except in premises registered under section 18.
Statutory basis: section 18, Cap. 219 R.E. 2023.
Applications for medical device import/export permits must be submitted at least 6 weeks prior to shipment of the consignment.
TMDA processes medical device import/export permit applications within 7 days.
Which evidence, local deltas, formats, and signatures are required?
All applications and supporting documents must be in Kiswahili or English.
New and re-registration applications for single-use devices must be accompanied by two commercial packs of samples (additional samples may be requested during evaluation); small reusable devices and lay-use devices likewise require two samples; applications without samples do not proceed to assessment.
For large medical devices, devices that are part of hospital infrastructure, and cardiac implants, submission of label artwork and scaled pictures of the device from different angles giving a 360-degree view suffices in lieu of physical samples.
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Applicants must have the device's class, intended purpose, GMDN code and term, conformity assessment certification and declaration of conformity before submitting; if the device is coded under another system instead of GMDN, that system must be specified.
Which current form, portal, account, and submission package must be used?
Applications are made through the TMDA Trader Portal: application invoices are sent to applicants via the portal and payment receipts are returned through the Trader's Portal.
All application fees are non-refundable and must be paid by the control number issued through the TMDA invoice; bank-transfer charges are borne by the applicant, who must send an advice note identifying the applicant, device and amount paid (plus registration number for registered devices).
Which QMS, audit, inspection, and certificate scope is accepted or required?
A valid certificate of compliance with ISO 13485 standards (or equivalent) from the manufacturer, issued by a recognized Conformity Assessment Body (CAB), is required; manufacturers in Tanzania must be registered by TMDA prior to notifying their products.
What review, validation, and applicant stop-clock rules apply?
When queries are raised, processing halts until the response is received; if no response to the query or request is received within 60 working days, the application is deemed withdrawn by the applicant.
The quality audit of manufacturing facilities is incorporated into the assessment process, but the published assessment timelines do not include the time for conducting site inspections.
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
After market authorization, all changes made to the product must be reported to TMDA; the MAH must submit applications for changes and provide scientific evidence that the changes do not negatively affect quality, safety or performance, per the Guidelines on Submission of Applications for Changes to Approved Medical Devices and In-vitro Diagnostics (TMDA/DMD/MDA/G/003).
Which UDI, device listing, database, and traceability duties apply?
Labels must incorporate the information required for Unique Device Identification (UDI) purposes per the labelling guideline; UDI is defined as a unique numeric or alphanumeric code that allows clear and unambiguous identification of specific devices on the market and facilitates traceability.
The Market Authorization Holder must maintain records of supply and records of complaints for all medical devices and accessories they have registered or notified, individually or as part of a device group.
Which clinical or IVD performance evidence or study is required and accepted?
No person may conduct a clinical trial of any medical device without the written authorisation of the Director General of TMDA.
A clinical trial application must be in the prescribed form, signed, accompanied by the prescribed fee, an Ethical Clearance Certificate issued by an approved institute for medical research, and relevant information per the clinical trial guidelines.
Where proof of clinical performance is required, clinical evidence must be submitted as part of the registration dossier; a clinical evaluation considers available relevant clinical data from published sources or device-related investigations, and additional clinical data may need to be generated for certain devices.
Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?
Upon application, TMDA may authorise the sale, supply, import or export of unregistered drugs, medical devices or herbal drugs for a specific purpose; such authorisation carries conditions and may be withdrawn.
Eligible applicants for TMDA medical device import/export permits include government and non-government institutions, wholesalers, manufacturers, clinical trial sponsors, principal investigators and researchers, and recipients of donations.
Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?
Submission of biannual post-marketing surveillance reports is a standing condition for validity of registration.
The applicant must conduct market surveillance activities once the product has been granted marketing authorization, and provide technical support and services to users of the registered device.
What is reportable, by whom, where, in what format, and by what deadline?
Adverse events/incidents and medical device/diagnostic problems are reported to TMDA through the Safety and Quality Reporting Tool (SQRT) at https://sqrt.tmda.go.tz/; all reports submitted are kept confidential.
Vigilance guideline PDFs (GUIDELINES ON VIGILANCE OF MEDICAL DEVICES) and publications/96, publications/110 links returned 404 on 2026-08-25; deadlines remain unverified from the primary guideline.
Submission of adverse effect reports associated with the use of the device is a standing condition for validity of registration.
The applicant and the Local Responsible Person must monitor the device on the market and inform TMDA immediately after detecting any problem relating to a registered device, such as serious manufacturing defects which may endanger public health.
Which recall, FSCA, notice, and authority-coordination duties apply?
The Market Authorization Holder must notify TMDA concerning field safety corrective action (FSCA), including recall, and must report defects and adverse effects to the Authority; handling device recalls is an applicant responsibility.
Where TMDA is satisfied that any regulated product is unfit for the intended use, it may seize, forfeit and condemn the product, declare it unfit and order its destruction at the owner's cost.
Which claims, audiences, channels, approvals, and restrictions apply?
No person may advertise any product regulated under Cap. 219 in a manner that is false, misleading or deceptive, or likely to create an erroneous impression regarding its character, value, quantity, composition, merit, safety or quality.
No person may carry out promotion activities on products regulated under Cap. 219 except after getting written approval from the Authority; retail advertising with bonuses, offers or discounts of regulated products is separately prohibited, with penalties from TZS 100,000 (individual) to TZS 1,000,000 or more (corporate).
How are deficiencies answered, clocks handled, and decisions escalated or appealed?
A person aggrieved by a decision of the Authority may appeal to the Minister against that decision; the Authority may appear as respondent and be heard, and the Attorney General may intervene.
An applicant aggrieved by a TMDA registration decision may first make representations in writing to TMDA; if still unsatisfied with the decision, the applicant may appeal to the Minister responsible for Health.
