Explore the medical device requirements currently available for Tanzania, organized by topic and linked to official sources.
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).
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.
Continued validity of registration is subject to payment of annual retention fees as prescribed in the current Fees and Charges Regulations in force.
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.
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.
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 clinical or IVD performance evidence or study is required and accepted?
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.
No person may conduct a clinical trial of any medical device without the written authorisation of the Director General of TMDA.
Is the product a device, IVD, accessory, software, or borderline product locally?
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.
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.
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.
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).
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).
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.
Which evidence, local deltas, formats, and signatures are required?
All applications and supporting documents must be in Kiswahili or English.
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.
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.
Excerpt preserves the source's typographical error 'angels'.
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.
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.
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.
Which label and IFU elements, languages, symbols, and translation controls apply?
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).
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.
Use of Kiswahili is required for home-use medical devices (labels and IFU).
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).
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.
Which current law, regulation, guidance, and transition provisions apply?
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.
Device classification and control rest on the TMDA (Control of Medical Devices) Regulations, GN No. 315 of 2015, as cited in the official compendium.
Excerpt preserves the source's typographical error 'Medica Devices'.
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.
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.
Effective from 2022-08-01
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).
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.
Which current form, portal, account, and submission package must be used?
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).
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.
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.
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 registration, notification, listing, reliance, or conformity route applies?
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.
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.
Which foreign decisions or evidence can be reused, with what effect and conditions?
Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.
No linked record is currently maintained. This does not establish that a pathway is unavailable.
Regulatory reference
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 assessment with no reference-authority list and no abridged pathway based on foreign approvals; TMDA's separate regulatory-reliance guideline (17 April 2025) covers marketing authorisation of human medicinal products only, and the only device-related reliance mechanism is the WHO Collaborative Registration Procedure for WHO-prequalified IVDs. An NMPA registration therefore gives no procedural benefit beyond documentary marketing-history evidence.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
tanzania
all device classes A (registrable), B, C, D and IVDs under standard registration
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2024-06-01
Source passage: According to The Tanzania Medicines and Medical devices (Control of Medical Devices) Regulations, 2015, all class A, B, C and D devices get market approval through registration while a selected class A devices attain market approval through notification. [...] For requirements for registration, please refer to Guidelines on Submission of Documentation for Registration of Medical Devices, third edition, April 2020 and Guidelines on submission of Documentation for Registration of In-vitro Diagnostic Devices, third edition, April 2020
Prior approval / evidence record
FDA 510(k)/PMA
Yes
Usable as supporting technical evidence, with no published reduction.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
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 for specialised devices such as MRI, ultrasound, X-ray and ECHO systems to submit a 'Certificate of market approval from any other country and market history', listing all countries where the device is marketed or withdrawn. An NMPA registration certificate satisfies this documentary requirement for a China-made device; the compendium names no reference regulatory authorities and provides no abridged route.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
tanzania
NMPA Class II/III certificates as foreign market-approval evidence; target Tanzania Class B, C and D specialised devices (MRI, ultrasound, X-ray, ECHO and similar)
Origin Country Evidence
Evidence Only
Product Marketing
Yes
Yes
Effective from 2024-06-01
Source passage: a) Certificate of market approval from any other country and market history. Brief description of the foreign marketing history, if any, of the device, including a list of all countries in which the device has been marketed and a list of all countries in which the device has been withdrawn from marketing for any reason related to the safety or effectiveness of the device.
Regulatory reference
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.
Prior approval / evidence record
CE Mark (EU MDR)
Yes
Usable as supporting technical evidence. The TMDA Compendium sets one 20-45 working-day service standard per class and publishes no origin-based reduction.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
What review, validation, and applicant stop-clock rules apply?
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.
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.
Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?
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.
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.
How are deficiencies answered, clocks handled, and decisions escalated or appealed?
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.
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.
Which UDI, device listing, database, and traceability duties apply?
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.
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.
What is reportable, by whom, where, in what format, and by what deadline?
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.
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.
tanzania:medical-device
tanzania
Risk classes A through D.
a
Class A
low
b
Class B
medium
c
Class C
high
d
Class D
highest
TMDA
official-source-verified
TMDA Compendium of Guidelines for Marketing Authorization of Medical Devices, Diagnostics and Laboratory Equipment (June 2024), Part V
https://www.tmda.go.tz/uploads/publications/en1755088789-Compendium%20of%20Guidelines%20for%20Marketing%20Authorization%20of%20Medical%20Devices%2C%20Diagnostics%20and%20Laboratory%20Equipment%2C%20June%202024.pdf
2026-08-25
Tanzania
tanzania
TZ
🇹🇿
Tanzania Medicines and Medical Devices Authority
TMDA
africa
3
4-class (A, B, C, D) — EU-aligned
class-a
Class A
low
TMDA registration
20
45
working-days
2
4
months
No
No
Yes
official-verified
TMDA Compendium of Guidelines (June 2024) — registration stage clocks
https://www.tmda.go.tz/uploads/publications/en1755088789-Compendium%20of%20Guidelines%20for%20Marketing%20Authorization%20of%20Medical%20Devices%2C%20Diagnostics%20and%20Laboratory%20Equipment%2C%20June%202024.pdf
2026-08-25
class-b
Class B
medium
TMDA registration
20
45
working-days
2
5
months
No
No
Yes
official-verified
TMDA Compendium of Guidelines (June 2024) — registration stage clocks
https://www.tmda.go.tz/uploads/publications/en1755088789-Compendium%20of%20Guidelines%20for%20Marketing%20Authorization%20of%20Medical%20Devices%2C%20Diagnostics%20and%20Laboratory%20Equipment%2C%20June%202024.pdf
2026-08-25
class-c
Class C
high
TMDA registration
45
45
working-days
3
6
months
No
No
Yes
official-verified
TMDA Compendium of Guidelines (June 2024) — registration stage clocks
https://www.tmda.go.tz/uploads/publications/en1755088789-Compendium%20of%20Guidelines%20for%20Marketing%20Authorization%20of%20Medical%20Devices%2C%20Diagnostics%20and%20Laboratory%20Equipment%2C%20June%202024.pdf
2026-08-25
class-d
Class D
highest
TMDA registration
45
45
working-days
4
8
months
Yes
No
Yes
official-verified
TMDA Compendium of Guidelines (June 2024) — registration stage clocks
https://www.tmda.go.tz/uploads/publications/en1755088789-Compendium%20of%20Guidelines%20for%20Marketing%20Authorization%20of%20Medical%20Devices%2C%20Diagnostics%20and%20Laboratory%20Equipment%2C%20June%202024.pdf
2026-08-25
CE Mark (EU MDR)
Yes
Usable as supporting technical evidence. The TMDA Compendium sets one 20-45 working-day service standard per class and publishes no origin-based reduction.
None published
FDA 510(k)/PMA
Yes
Usable as supporting technical evidence, with no published reduction.
None published
Yes
Tanzanian Authorized Representative
No
Not accepted
5 years
official-verified
TMDA Compendium of Guidelines (June 2024) — registration stage clocks
https://www.tmda.go.tz/uploads/publications/en1755088789-Compendium%20of%20Guidelines%20for%20Marketing%20Authorization%20of%20Medical%20Devices%2C%20Diagnostics%20and%20Laboratory%20Equipment%2C%20June%202024.pdf
2026-08-25
2026-08-30
2026-08-30
default
planning-template
Maintained planning steps and estimates, not verified regulator deadlines.
1
Pre-Submission Preparation
Gather technical documentation, quality management system (QMS) records, and clinical data required by TMDA. Appoint a Tanzanian Authorized Representative.
1-3 months
📋
2
Application Submission
Submit complete registration dossier to TMDA including device description, risk analysis, and testing reports.
1-2 weeks
📤
3
Administrative Review
TMDA reviews application for completeness. May request additional documents or clarifications.
2-4 weeks
🔍
4
Technical Evaluation
In-depth technical assessment of device safety and performance. TMDA may issue questions.
20-45 working days
⚙️
5
Registration Approval
Upon successful review, TMDA issues Tanzania market authorization certificate.
1-2 weeks
✅
tanzania
Tanzania
TZ
TMDA
50
500
USD
Yes
2500
2500
USD
Yes
imported-device-notification
Imported non-registrable Class A device notification
USD
50
USD 50
Per notification
The June 2024 amendment sets USD 50; the TMDA web page still displays USD 100 for this row — the amendment controls.
exact-current
official-verified
https://www.tmda.go.tz/uploads/1718887575-FEES%20AND%20CHARGES%20AMENDMENT%20JUNE%202024%20FINAL.pdf
TMDA Fees and Charges Amendment, June 2024
2024-06-01
2026-08-25
imported-device-class-a
Imported device - Class A
USD
500
USD 500
Per application
exact-current
official-verified
https://www.tmda.go.tz/uploads/1718887575-FEES%20AND%20CHARGES%20AMENDMENT%20JUNE%202024%20FINAL.pdf
TMDA Fees and Charges Amendment, June 2024
2024-06-01
2026-08-25
imported-device-class-b-d
Imported device - Class B/C/D
USD
2500
USD 2,500
Per application
exact-current
official-verified
https://www.tmda.go.tz/uploads/1718887575-FEES%20AND%20CHARGES%20AMENDMENT%20JUNE%202024%20FINAL.pdf
TMDA Fees and Charges Amendment, June 2024
2024-06-01
2026-08-25
imported-device-major-variation
Imported device - major variation
USD
300
USD 300
Per variation
exact-current
official-verified
https://www.tmda.go.tz/index.php/pages/medical-devices-assessment-fees-and-charges
TMDA medical-devices assessment fees and charges (Fees and Charges Regulation 2022, GN No. 686)
2026-08-25
imported-device-minor-variation
Imported device - minor variation
USD
150
USD 150
Per variation
exact-current
official-verified
https://www.tmda.go.tz/index.php/pages/medical-devices-assessment-fees-and-charges
TMDA medical-devices assessment fees and charges (Fees and Charges Regulation 2022, GN No. 686)
2026-08-25
retention-registered-devices
Annual retention - imported registered devices
USD
200
USD 200
Annual
exact-current
official-verified
https://www.tmda.go.tz/index.php/pages/medical-devices-assessment-fees-and-charges
TMDA medical-devices assessment fees and charges (Fees and Charges Regulation 2022, GN No. 686)
2026-08-25
retention-notified-devices
Annual retention - imported notified devices
USD
50
USD 50
Annual
exact-current
official-verified
https://www.tmda.go.tz/index.php/pages/medical-devices-assessment-fees-and-charges
TMDA medical-devices assessment fees and charges (Fees and Charges Regulation 2022, GN No. 686)
2026-08-25
ivd-imported-notification
IVD imported - notification
USD
100
USD 100
Per notification
exact-current
official-verified
https://www.tmda.go.tz/index.php/pages/medical-devices-assessment-fees-and-charges
TMDA medical-devices assessment fees and charges (Fees and Charges Regulation 2022, GN No. 686)
2026-08-25
ivd-imported-class-a
IVD imported - Class A
USD
300
USD 300
Per application
exact-current
official-verified
https://www.tmda.go.tz/index.php/pages/medical-devices-assessment-fees-and-charges
TMDA medical-devices assessment fees and charges (Fees and Charges Regulation 2022, GN No. 686)
2026-08-25
ivd-imported-class-b
IVD imported - Class B
USD
1000
USD 1,000
Per application
exact-current
official-verified
https://www.tmda.go.tz/index.php/pages/medical-devices-assessment-fees-and-charges
TMDA medical-devices assessment fees and charges (Fees and Charges Regulation 2022, GN No. 686)
2026-08-25
ivd-imported-class-c
IVD imported - Class C
USD
1500
USD 1,500
Per application
exact-current
official-verified
https://www.tmda.go.tz/index.php/pages/medical-devices-assessment-fees-and-charges
TMDA medical-devices assessment fees and charges (Fees and Charges Regulation 2022, GN No. 686)
2026-08-25
ivd-imported-class-d
IVD imported - Class D
USD
2000
USD 2,000
Per application
exact-current
official-verified
https://www.tmda.go.tz/index.php/pages/medical-devices-assessment-fees-and-charges
TMDA medical-devices assessment fees and charges (Fees and Charges Regulation 2022, GN No. 686)
2026-08-25
domestic-device-notification
Domestic device - notification
TZS
50000
TZS 50,000
Per notification
exact-current
official-verified
https://www.tmda.go.tz/index.php/pages/medical-devices-assessment-fees-and-charges
TMDA medical-devices assessment fees and charges (Fees and Charges Regulation 2022, GN No. 686)
2026-08-25
domestic-device-class-a
Domestic device - Class A registration
TZS
100000
TZS 100,000
Per registration
exact-current
official-verified
https://www.tmda.go.tz/index.php/pages/medical-devices-assessment-fees-and-charges
TMDA medical-devices assessment fees and charges (Fees and Charges Regulation 2022, GN No. 686)
2026-08-25
domestic-device-class-b
Domestic device - Class B registration
TZS
200000
TZS 200,000
Per registration
exact-current
official-verified
https://www.tmda.go.tz/index.php/pages/medical-devices-assessment-fees-and-charges
TMDA medical-devices assessment fees and charges (Fees and Charges Regulation 2022, GN No. 686)
2026-08-25
domestic-device-class-c-d
Domestic device - Class C/D registration
TZS
500000
TZS 500,000
Per registration
exact-current
official-verified
https://www.tmda.go.tz/index.php/pages/medical-devices-assessment-fees-and-charges
TMDA medical-devices assessment fees and charges (Fees and Charges Regulation 2022, GN No. 686)
2026-08-25
domestic-device-major-variation
Domestic device - major variation
TZS
150000
TZS 150,000
Per variation
exact-current
official-verified
https://www.tmda.go.tz/index.php/pages/medical-devices-assessment-fees-and-charges
TMDA medical-devices assessment fees and charges (Fees and Charges Regulation 2022, GN No. 686)
2026-08-25
domestic-device-minor-variation
Domestic device - minor variation
TZS
100000
TZS 100,000
Per variation
exact-current
official-verified
https://www.tmda.go.tz/index.php/pages/medical-devices-assessment-fees-and-charges
TMDA medical-devices assessment fees and charges (Fees and Charges Regulation 2022, GN No. 686)
2026-08-25
2026-08-25
official-verified
TMDA Fees and Charges Amendment, June 2024
https://www.tmda.go.tz/uploads/1718887575-FEES%20AND%20CHARGES%20AMENDMENT%20JUNE%202024%20FINAL.pdf
2024-06-01
2026-08-25
TMDA medical-devices assessment fees and charges (Fees and Charges Regulation 2022, GN No. 686)
https://www.tmda.go.tz/index.php/pages/medical-devices-assessment-fees-and-charges
2026-08-25
2026-08-25
exact-current
Yes
tanzania
Tanzania
low
tmda-electrical-emc-evidence
TMDA electrical/EMC evidence
Medical Electrical Safety
Included In Medical Registration
Finished Device
TMDA compendium (June 2024): ISO 10993 series treated as the gold standard for biocompatibility, with validated alternative methods needing justification; measuring-function devices where inaccuracy could significantly harm the patient need metrological conformity studies (traceability also for IVD calibrators); special packaging needs seal-integrity and sterility evidence (e.g. bubble, dye-penetration tests); IMDRF/SaMD guidance referenced for software.
reviewed
tcra-type-approval
TCRA Type Approval
Radio Spectrum
Mandatory If Feature
Covered Telecommunications Or Radio Equipment
candidate
tbs-pvoc-certificate-of-conformity
TBS PVoC Certificate of Conformity
Import Conformity
Mandatory At Import
Shipment With Regulated Hs Code
candidate
TCRA
telecommunications and radiocommunications equipment type approval
https://www.tcra.go.tz/download/sw-1702550035-GUIDELINES%20FOR%20TYPE%20APPROVAL%20OF%20ELECTRONIC%20COMMUNICATION%20EQUIPMENT.pdf
TBS
PVoC and import controls
https://www.tbs.go.tz/pages/import-and-export-control
TMDA
compendium of guidelines ISO 10993 metrology and packaging evidence
https://www.tmda.go.tz/uploads/publications/en1755088789-Compendium%20of%20Guidelines%20for%20Marketing%20Authorization%20of%20Medical%20Devices%2C%20Diagnostics%20and%20Laboratory%20Equipment%2C%20June%202024.pdf
