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TMDA · Middle East & Africa

Tanzania medical device regulatory resources

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4,679 public device record records10 free resources24/25 topics with records3 regulations trackedAug 2026 fees reviewed
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Medical device registration database

Search official TMDA device registration records.

Medical device registry insights

Explore market trends, registrations, manufacturers, and local representatives.

Medical device regulations

Browse official TMDA regulations and guidance documents.

AI medical device classifier

Describe your device and get a preliminary TMDA risk class with an explanation and source links.

Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Tanzania requirements.

AI similar registered product finder

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Medical device regulation news

Follow recent TMDA policy, guidance, safety, and compliance updates.

Government registration fees

Review current TMDA medical-device assessment fees.

Regulatory requirements data

Browse source-linked lifecycle, language, local-role, renewal, and change-control facts.

Registration timeline

Compare official and realistic TMDA approval times by device class and pathway.

Structured regulatory requirements

Explore all 61 source-linked facts →

24 of 25 research dimensions currently covered · 12 official sources · latest verification 2026-09-15

Market entry

D01

Authority & regime

Verified
Competent authority
The Tanzania Medicines and Medical Devices Authority (TMDA) is the authority that approves registration of medical devices in Mainland Tanzania, acting under the Tanzania Medicines and Medi…
Jurisdiction limited to Mainland Tanzania
The Act's import/export control operates on trade 'into Mainland Tanzania'; TMDA's device regime covers Mainland Tanzania only.
2 source-linked facts
Checked 2026-08-25
Open details →
D02

Legal basis & guidance

Verified
Marketing authorization guideline in force
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.
Medical device regulations in force
Device classification and control rest on the TMDA (Control of Medical Devices) Regulations, GN No. 315 of 2015, as cited in the official compendium.
5 source-linked facts
Checked 2026-08-25
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D03

Device definition & scope

Verified
Accessories classified in their own right
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 access…
IVD definition
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,…
7 source-linked facts
Checked 2026-08-25
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D05

Registration pathways

Verified
Grouping: one unit per application
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 o…
Registration vs notification route split
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…
2 source-linked facts
Checked 2026-08-25
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D06

Reliance & recognition

Verified
China NMPA approval: no recognition regime
statement: TMDA's device registration framework (Control of Medical Devices Regulations 2015 and the June 2024 Compendium) subjects all Class A D devices and IVDs to independent dossier ass…
China NMPA approval: market-approval evidence for specialised-device applications
statement: TMDA's Compendium of Guidelines for Marketing Authorization of Medical Devices, Diagnostics and Laboratory Equipment (TMDA/DMD/MDA/G/001 Rev 03, June 2024) requires applicants fo…
3 source-linked facts
Checked 2026-09-15
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D07

Economic-operator roles

Verified
Applicant and Local Responsible Person
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 Represen…
1 source-linked fact
Checked 2026-08-25
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D08

Establishment, import & distribution

Verified
Import/export requires licence or permit
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.
Import permit application timing
Applications for medical device import/export permits must be submitted at least 6 weeks prior to shipment of the consignment.
4 source-linked facts
Checked 2026-08-25
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D09

Dossier requirements

Verified
Application language
All applications and supporting documents must be in Kiswahili or English.
GMDN nomenclature requirement
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 un…
4 source-linked facts
Checked 2026-08-25
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D10

Official forms & portals

Verified
Fee payment by control number
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 not…
TMDA Trader's Portal
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.
2 source-linked facts
Checked 2026-08-25
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Submission & evidence

D11

Label, IFU & language

Verified
Electronic IFU conditions
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…
Implant card with UDI
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/addres…
5 source-linked facts
Checked 2026-08-26
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D12

QMS, audit & inspection

Verified
ISO 13485 certificate 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 Tanz…
1 source-linked fact
Checked 2026-08-25
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D13

Standards, testing & ancillary approvals

Unresolved
TMDA electrical/EMC evidence
Electrical safety
TCRA Type Approval
Wireless / radio
TBS PVoC Certificate of Conformity
Import CoC / PVoC
3 maintained overlays
Open details →
D15

Review clocks

Verified
Class A · TMDA registration
20-45 working days
Class B · TMDA registration
20-45 working days
Class C · TMDA registration
45 working days
4 maintained pathways · 2 related facts
Checked 2026-08-30
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D16

Approval validity & renewal

Verified
Authorization duration
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.
Annual retention fee condition
Continued validity of registration is subject to payment of annual retention fees as prescribed in the current Fees and Charges Regulations in force.
4 source-linked facts
Checked 2026-08-26
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Lifecycle & post-market

D17

Change control

Verified
Changes to registered devices require 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 ne…
1 source-linked fact
Checked 2026-08-25
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D18

UDI, listing & traceability

Verified
Supply and complaint records duty
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 o…
UDI information on label
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 al…
2 source-linked facts
Checked 2026-08-25
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D19

Clinical investigation & performance

Verified
Clinical trial application contents
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…
Clinical evidence in dossier
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 fr…
3 source-linked facts
Checked 2026-08-25
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D20

Special access & derogation

Verified
Import permit eligible applicants
Eligible applicants for TMDA medical device import/export permits include government and non government institutions, wholesalers, manufacturers, clinical trial sponsors, principal investig…
Authorisation for unregistered devices
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…
2 source-linked facts
Checked 2026-08-25
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D21

Manufacturer PMS

Verified
Biannual PMS reports
Submission of biannual post marketing surveillance reports is a standing condition for validity of registration.
Applicant market surveillance duty
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 de…
2 source-linked facts
Checked 2026-08-25
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D22

Vigilance & incident reporting

Verified
Adverse effect reports condition
Submission of adverse effect reports associated with the use of the device is a standing condition for validity of registration.
Immediate notification of serious defects
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…
3 source-linked facts
Checked 2026-08-25
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D23

Recall, FSCA & market surveillance

Verified
FSCA notification duty
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 d…
Seizure and destruction of unfit products
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 co…
2 source-linked facts
Checked 2026-08-25
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D24

Advertising, claims & promotion

Verified
False or misleading advertising prohibited
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,…
Promotion activities require written approval
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 discou…
2 source-linked facts
Checked 2026-08-25
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D25

Submission communications & appeal

Verified
Written representations before appeal
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 re…
Appeal to the Minister
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 interve…
2 source-linked facts
Checked 2026-08-25
Open details →

Government fees

Full fee schedule (18 lines) →

TMDA registration fees in USD · reviewed 2026-08-25

Fee lineAmountProvenance
Imported non-registrable Class A device notificationUSD 50Verified
Imported device - Class AUSD 500Verified
Imported device - Class B/C/DUSD 2,500Verified
Imported device - major variationUSD 300Verified
14 more fee lines on the full schedule · 18 of 18 rows source-verified

Registration timeline

Full registration timeline →

Tanzania Medicines and Medical Devices Authority (TMDA) review clocks and planning ranges · 4-class (A, B, C, D) — EU-aligned classification

Class / pathwayReview clockPlanning totalProvenance
Class A(TMDA registration)20-45 working days2-4 monthsVerified
Class B(TMDA registration)20-45 working days2-5 monthsVerified
Class C(TMDA registration)45 working days3-6 monthsVerified
Class D(TMDA registration)45 working days4-8 monthsVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(20-45 working days)
  5. 5Registration Approval(1-2 weeks)

Latest regulation news

All Tanzania regulation news →

Newest official TMDA headlines from the daily-refreshed feed — every row links directly to the authority publication.

Aug 17TMTMDAApproval and Gazetting of the Tanzania Medicines and Medical Devices (Control of Blood and Blood Products) Regulations, 2026TanzaniaJul 3TMTMDARegulatory Reliance Pathways for Marketing Authorisation of Human Medicinal ProductsTanzania

Key regulations

All 3 Tanzania regulations →

Official TMDA rules and guidance · 3 of 3 documents linked to official sources

Medical Device and In Vitro Diagnostic Devices RegulationsMedical Device and IVD Regulations
RegistrationVerified
Tanzania Medicines and Medical Devices Act, Cap. 219Tanzania Medicines and Medical Devices Act
GeneralVerified
TMDA/DMD/MDA/G/001 Rev 03Compendium of Guidelines for Marketing Authorization of Medical Devices, Diagnostics and Laboratory Equipment
RegistrationVerified

Registry insights

Full registry statistics →

Computed from 4,679 official TMDA public device record records · data as of 2026-09-18

4,679
Public device records
1,694
Manufacturers
623
Registrants
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