TMDA · structured requirements

🇹🇿 Tanzania IVD regulatory data

Explore the IVD requirements currently available for Tanzania, organized by topic and linked to official sources.

2 facts1 dimensions2 official sourceslatest verification 2026-09-15

Changes after registration

Common questions about changing a registered IVD in Tanzania. Each question separates published rules from details still awaiting verification.

Does changing a device brand name or logo require an update? →Specific rules awaiting verification
How do I update a manufacturer's name without changing the legal entity? →Specific rules awaiting verification
What changes when the manufacturer's office address changes? →Specific rules awaiting verification
Does a catalogue or reference code change affect registration or UDI? →Specific rules awaiting verification
Can a registration transfer to a different legal entity? →Specific rules awaiting verification
Can several changes be filed together? →Specific rules awaiting verification

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

Compare countries

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.

Tanzania approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Tanzania (4 records)

TanzaniaNMPA

Regulatory reference

China NMPA approval: no recognition regime

reliance.china-nmpa-no-recognition-route

Pending verification

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 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.
Source Jurisdiction Id: china
Source Authority Id: nmpa
Source Approval: China NMPA medical device registration certificate (Class II/III) or Class I filing record
Target Jurisdiction Id: tanzania
China Classes In Scope: all device classes A (registrable), B, C, D and IVDs under standard registration
Edge Type: No Reliance Route
Market Access Strength: none
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Registration via online Trader Portal; ISO 13485 evidence for notification of Class A devices.
WHO CRP applies only to WHO-prequalified IVDs (held fact).
Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

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

TanzaniaUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: Usable as supporting technical evidence, with no published reduction.
Timeline Savings: None published

TMDA Compendium of Guidelines (June 2024) — registration stage clocks

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

TanzaniaNMPA

Prior approval / evidence record

China NMPA approval: market-approval evidence for specialised-device applications

reliance.china-nmpa-origin-evidence

Pending verification

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 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.
Source Jurisdiction Id: china
Source Authority Id: nmpa
Source Approval: China NMPA medical device registration certificate (Class II/III) or Class I filing record
Target Jurisdiction Id: tanzania
China Classes In Scope: 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)
Edge Type: Origin Country Evidence
Market Access Strength: Evidence Only
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Applies to the 'Requirements for Registration of Specialized Medical Devices' section; other devices follow the general IMDRF-style dossier.
Manufacturer's Declaration of Conformity, certificate of analysis and operator manual also required.
Registration valid five years.
Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

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.

TanzaniaEU conformity assessment

Prior approval / evidence record

CE Mark (EU MDR)

Authority: CE Mark (EU MDR)
Accepted: Yes
Benefit: Usable as supporting technical evidence. The TMDA Compendium sets one 20-45 working-day service standard per class and publishes no origin-based reduction.
Timeline Savings: None published

TMDA Compendium of Guidelines (June 2024) — registration stage clocks

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Related structured datasets

Classification systems · 1 record

Open Risk classes A through D. →

tanzania:medical-device

Jurisdiction Id

tanzania

Domains

medical-device
ivd

Name

Risk classes A through D.

Classes

Id
a
Label
Class A
Normalized Risk Level
low
Id
b
Label
Class B
Normalized Risk Level
medium
Id
c
Label
Class C
Normalized Risk Level
high
Id
d
Label
Class D
Normalized Risk Level
highest

Regulator

TMDA

Official Domains

tmda.go.tz

Source Status

official-source-verified

Source Title

TMDA Compendium of Guidelines for Marketing Authorization of Medical Devices, Diagnostics and Laboratory Equipment (June 2024), Part V

Source Url

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

Verified On

2026-08-25

Source Supports

class-axis
classification-rules
ivd-class-axis
ivd-classification-rules

Notes

Four GHTF-based classes A-D (A low, B low-moderate, C moderate-high, D high); the manufacturer is responsible for classifying but TMDA reserves the right to decide the class.
Where more than one classification rule applies, the rules resulting in the highest risk classification apply; classification rules are those of the Control of Medical Devices Regulations GN.315 (Part V MD / Part VI IVD of the compendium).

Registration pathways, prior approvals and planning · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Tanzania registration →

Country

Tanzania

Jurisdiction Id

tanzania

Country Code

Flag

🇹🇿

Regulator

Tanzania Medicines and Medical Devices Authority

Regulator Abbrev

TMDA

Region

africa

Tier

Risk Classification

4-class (A, B, C, D) — EU-aligned

Classes

Id
class-a
Class Name
Class A
Risk Level
low
Pathway
TMDA registration
Official Timeline
Min
20
Max
45
Unit
working-days
Realistic Timeline
Min
2
Max
4
Unit
months
Notes
Compendium of service standards: 20-45 working days end-to-end (screening 1-2, scheduling 10-20, assessment 23-40, QA 5-8, admin 5-25)
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
Yes
Verification Status
official-verified
Official Source
Title
TMDA Compendium of Guidelines (June 2024) — registration stage clocks
Url
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
Accessed Date
2026-08-25
Id
class-b
Class Name
Class B
Risk Level
medium
Pathway
TMDA registration
Official Timeline
Min
20
Max
45
Unit
working-days
Realistic Timeline
Min
2
Max
5
Unit
months
Notes
Compendium of service standards: 20-45 working days end-to-end (screening 1-2, scheduling 10-20, assessment 23-40, QA 5-8, admin 5-25)
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
Yes
Verification Status
official-verified
Official Source
Title
TMDA Compendium of Guidelines (June 2024) — registration stage clocks
Url
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
Accessed Date
2026-08-25
Id
class-c
Class Name
Class C
Risk Level
high
Pathway
TMDA registration
Official Timeline
Min
45
Max
45
Unit
working-days
Realistic Timeline
Min
3
Max
6
Unit
months
Notes
Compendium of service standards: up to 45 working days end-to-end (screening 1-2, scheduling 10-20, assessment 23-40, QA 5-8, admin 5-25)
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
Yes
Verification Status
official-verified
Official Source
Title
TMDA Compendium of Guidelines (June 2024) — registration stage clocks
Url
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
Accessed Date
2026-08-25
Id
class-d
Class Name
Class D
Risk Level
highest
Pathway
TMDA registration
Official Timeline
Min
45
Max
45
Unit
working-days
Realistic Timeline
Min
4
Max
8
Unit
months
Notes
Compendium of service standards: up to 45 working days end-to-end (screening 1-2, scheduling 10-20, assessment 23-40, QA 5-8, admin 5-25)
Clinical Trial Required
Yes
Local Testing Required
No
Gmp Required
Yes
Verification Status
official-verified
Official Source
Title
TMDA Compendium of Guidelines (June 2024) — registration stage clocks
Url
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
Accessed Date
2026-08-25

Key Requirements

Local Authorized Representative required for foreign manufacturers
Screening-to-notification stages: screening 1-2 wd, scheduling 10-20 wd, assessment 23-40 wd, QA 5-8 wd, admin 5-25 wd
Registration certificate notification within 5 working days of decision; variations decided within 10 days

Prior Approvals

Authority
CE Mark (EU MDR)
Accepted
Yes
Benefit
Usable as supporting technical evidence. The TMDA Compendium sets one 20-45 working-day service standard per class and publishes no origin-based reduction.
Timeline Savings
None published
Authority
FDA 510(k)/PMA
Accepted
Yes
Benefit
Usable as supporting technical evidence, with no published reduction.
Timeline Savings
None published

Local Rep Required

Yes

Local Rep Name

Tanzanian Authorized Representative

Mdsap Accepted

Mdsap Benefit

Not accepted

Registration Validity

5 years

Verification Status

official-verified

Official Sources

Title
TMDA Compendium of Guidelines (June 2024) — registration stage clocks
Url
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
Accessed Date
2026-08-25

Reviewed On

2026-08-30

Last Updated

2026-08-30

Process

Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps

Step
1
Title
Pre-Submission Preparation
Description
Gather technical documentation, quality management system (QMS) records, and clinical data required by TMDA. Appoint a Tanzanian Authorized Representative.
Duration
1-3 months
Icon
📋
Step
2
Title
Application Submission
Description
Submit complete registration dossier to TMDA including device description, risk analysis, and testing reports.
Duration
1-2 weeks
Icon
📤
Step
3
Title
Administrative Review
Description
TMDA reviews application for completeness. May request additional documents or clarifications.
Duration
2-4 weeks
Icon
🔍
Step
4
Title
Technical Evaluation
Description
In-depth technical assessment of device safety and performance. TMDA may issue questions.
Duration
20-45 working days
Icon
⚙️
Step
5
Title
Registration Approval
Description
Upon successful review, TMDA issues Tanzania market authorization certificate.
Duration
1-2 weeks
Icon
✅

Government fee schedules · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Tanzania fees →

Jurisdiction Id

tanzania

Country

Tanzania

Country Code

Authority

TMDA

Low Risk Local

Min: 50
Max: 500
Currency: USD
Per Product: Yes

High Risk Local

Min: 2500
Max: 2500
Currency: USD
Per Product: Yes

Details

Id
imported-device-notification
Item
Imported non-registrable Class A device notification
Currency
USD
Amount Local
50
Amount Local Formatted
USD 50
Frequency
Per notification
Notes
The June 2024 amendment sets USD 50; the TMDA web page still displays USD 100 for this row — the amendment controls.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.tmda.go.tz/uploads/1718887575-FEES%20AND%20CHARGES%20AMENDMENT%20JUNE%202024%20FINAL.pdf
Source Title
TMDA Fees and Charges Amendment, June 2024
Source Effective Date
2024-06-01
Verified On
2026-08-25
Id
imported-device-class-a
Item
Imported device - Class A
Currency
USD
Amount Local
500
Amount Local Formatted
USD 500
Frequency
Per application
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.tmda.go.tz/uploads/1718887575-FEES%20AND%20CHARGES%20AMENDMENT%20JUNE%202024%20FINAL.pdf
Source Title
TMDA Fees and Charges Amendment, June 2024
Source Effective Date
2024-06-01
Verified On
2026-08-25
Id
imported-device-class-b-d
Item
Imported device - Class B/C/D
Currency
USD
Amount Local
2500
Amount Local Formatted
USD 2,500
Frequency
Per application
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.tmda.go.tz/uploads/1718887575-FEES%20AND%20CHARGES%20AMENDMENT%20JUNE%202024%20FINAL.pdf
Source Title
TMDA Fees and Charges Amendment, June 2024
Source Effective Date
2024-06-01
Verified On
2026-08-25
Id
imported-device-major-variation
Item
Imported device - major variation
Currency
USD
Amount Local
300
Amount Local Formatted
USD 300
Frequency
Per variation
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.tmda.go.tz/index.php/pages/medical-devices-assessment-fees-and-charges
Source Title
TMDA medical-devices assessment fees and charges (Fees and Charges Regulation 2022, GN No. 686)
Verified On
2026-08-25
Id
imported-device-minor-variation
Item
Imported device - minor variation
Currency
USD
Amount Local
150
Amount Local Formatted
USD 150
Frequency
Per variation
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.tmda.go.tz/index.php/pages/medical-devices-assessment-fees-and-charges
Source Title
TMDA medical-devices assessment fees and charges (Fees and Charges Regulation 2022, GN No. 686)
Verified On
2026-08-25
Id
retention-registered-devices
Item
Annual retention - imported registered devices
Currency
USD
Amount Local
200
Amount Local Formatted
USD 200
Frequency
Annual
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.tmda.go.tz/index.php/pages/medical-devices-assessment-fees-and-charges
Source Title
TMDA medical-devices assessment fees and charges (Fees and Charges Regulation 2022, GN No. 686)
Verified On
2026-08-25
Id
retention-notified-devices
Item
Annual retention - imported notified devices
Currency
USD
Amount Local
50
Amount Local Formatted
USD 50
Frequency
Annual
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.tmda.go.tz/index.php/pages/medical-devices-assessment-fees-and-charges
Source Title
TMDA medical-devices assessment fees and charges (Fees and Charges Regulation 2022, GN No. 686)
Verified On
2026-08-25
Id
ivd-imported-notification
Item
IVD imported - notification
Currency
USD
Amount Local
100
Amount Local Formatted
USD 100
Frequency
Per notification
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.tmda.go.tz/index.php/pages/medical-devices-assessment-fees-and-charges
Source Title
TMDA medical-devices assessment fees and charges (Fees and Charges Regulation 2022, GN No. 686)
Verified On
2026-08-25
Id
ivd-imported-class-a
Item
IVD imported - Class A
Currency
USD
Amount Local
300
Amount Local Formatted
USD 300
Frequency
Per application
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.tmda.go.tz/index.php/pages/medical-devices-assessment-fees-and-charges
Source Title
TMDA medical-devices assessment fees and charges (Fees and Charges Regulation 2022, GN No. 686)
Verified On
2026-08-25
Id
ivd-imported-class-b
Item
IVD imported - Class B
Currency
USD
Amount Local
1000
Amount Local Formatted
USD 1,000
Frequency
Per application
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.tmda.go.tz/index.php/pages/medical-devices-assessment-fees-and-charges
Source Title
TMDA medical-devices assessment fees and charges (Fees and Charges Regulation 2022, GN No. 686)
Verified On
2026-08-25
Id
ivd-imported-class-c
Item
IVD imported - Class C
Currency
USD
Amount Local
1500
Amount Local Formatted
USD 1,500
Frequency
Per application
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.tmda.go.tz/index.php/pages/medical-devices-assessment-fees-and-charges
Source Title
TMDA medical-devices assessment fees and charges (Fees and Charges Regulation 2022, GN No. 686)
Verified On
2026-08-25
Id
ivd-imported-class-d
Item
IVD imported - Class D
Currency
USD
Amount Local
2000
Amount Local Formatted
USD 2,000
Frequency
Per application
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.tmda.go.tz/index.php/pages/medical-devices-assessment-fees-and-charges
Source Title
TMDA medical-devices assessment fees and charges (Fees and Charges Regulation 2022, GN No. 686)
Verified On
2026-08-25
Id
domestic-device-notification
Item
Domestic device - notification
Currency
TZS
Amount Local
50000
Amount Local Formatted
TZS 50,000
Frequency
Per notification
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.tmda.go.tz/index.php/pages/medical-devices-assessment-fees-and-charges
Source Title
TMDA medical-devices assessment fees and charges (Fees and Charges Regulation 2022, GN No. 686)
Verified On
2026-08-25
Id
domestic-device-class-a
Item
Domestic device - Class A registration
Currency
TZS
Amount Local
100000
Amount Local Formatted
TZS 100,000
Frequency
Per registration
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.tmda.go.tz/index.php/pages/medical-devices-assessment-fees-and-charges
Source Title
TMDA medical-devices assessment fees and charges (Fees and Charges Regulation 2022, GN No. 686)
Verified On
2026-08-25
Id
domestic-device-class-b
Item
Domestic device - Class B registration
Currency
TZS
Amount Local
200000
Amount Local Formatted
TZS 200,000
Frequency
Per registration
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.tmda.go.tz/index.php/pages/medical-devices-assessment-fees-and-charges
Source Title
TMDA medical-devices assessment fees and charges (Fees and Charges Regulation 2022, GN No. 686)
Verified On
2026-08-25
Id
domestic-device-class-c-d
Item
Domestic device - Class C/D registration
Currency
TZS
Amount Local
500000
Amount Local Formatted
TZS 500,000
Frequency
Per registration
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.tmda.go.tz/index.php/pages/medical-devices-assessment-fees-and-charges
Source Title
TMDA medical-devices assessment fees and charges (Fees and Charges Regulation 2022, GN No. 686)
Verified On
2026-08-25
Id
domestic-device-major-variation
Item
Domestic device - major variation
Currency
TZS
Amount Local
150000
Amount Local Formatted
TZS 150,000
Frequency
Per variation
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.tmda.go.tz/index.php/pages/medical-devices-assessment-fees-and-charges
Source Title
TMDA medical-devices assessment fees and charges (Fees and Charges Regulation 2022, GN No. 686)
Verified On
2026-08-25
Id
domestic-device-minor-variation
Item
Domestic device - minor variation
Currency
TZS
Amount Local
100000
Amount Local Formatted
TZS 100,000
Frequency
Per variation
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.tmda.go.tz/index.php/pages/medical-devices-assessment-fees-and-charges
Source Title
TMDA medical-devices assessment fees and charges (Fees and Charges Regulation 2022, GN No. 686)
Verified On
2026-08-25

Notes

Fees follow the Tanzania Medicines and Medical Devices (Fees and Charges) Regulation 2022 (GN No. 686) as displayed by TMDA; the June 2024 amendment controls where the page disagrees (imported notification USD 50).
Domestic-retention amounts print "NA" on the TMDA page and need confirmation against GN No. 686; imported retention is USD 200 registered / USD 50 notified.
Domestic IVD rows mirror the medical-device table (TZS 100,000/200,000/500,000 by class).

Last Updated

2026-08-25

Verification Status

official-verified

Official Sources

Title
TMDA Fees and Charges Amendment, June 2024
Url
https://www.tmda.go.tz/uploads/1718887575-FEES%20AND%20CHARGES%20AMENDMENT%20JUNE%202024%20FINAL.pdf
Effective Date
2024-06-01
Accessed Date
2026-08-25
Title
TMDA medical-devices assessment fees and charges (Fees and Charges Regulation 2022, GN No. 686)
Url
https://www.tmda.go.tz/index.php/pages/medical-devices-assessment-fees-and-charges
Accessed Date
2026-08-25

Reviewed On

2026-08-25

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Tanzania certifications →

Slug

tanzania

Market

Tanzania

Confidence

low

Schemes

Id
tmda-electrical-emc-evidence
Name
TMDA electrical/EMC evidence
Category
Medical Electrical Safety
Status
Included In Medical Registration
Object
Finished Device
Note
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.
Source Urls
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
Source Binding
reviewed
Id
tcra-type-approval
Name
TCRA Type Approval
Category
Radio Spectrum
Status
Mandatory If Feature
Object
Covered Telecommunications Or Radio Equipment
Source Urls
https://www.tcra.go.tz/download/sw-1702550035-GUIDELINES%20FOR%20TYPE%20APPROVAL%20OF%20ELECTRONIC%20COMMUNICATION%20EQUIPMENT.pdf
Source Binding
candidate
Id
tbs-pvoc-certificate-of-conformity
Name
TBS PVoC Certificate of Conformity
Category
Import Conformity
Status
Mandatory At Import
Object
Shipment With Regulated Hs Code
Source Urls
https://www.tbs.go.tz/pages/import-and-export-control
Source Binding
candidate

Official Sources

Authority
TCRA
Topic
telecommunications and radiocommunications equipment type approval
Url
https://www.tcra.go.tz/download/sw-1702550035-GUIDELINES%20FOR%20TYPE%20APPROVAL%20OF%20ELECTRONIC%20COMMUNICATION%20EQUIPMENT.pdf
Authority
TBS
Topic
PVoC and import controls
Url
https://www.tbs.go.tz/pages/import-and-export-control
Authority
TMDA
Topic
compendium of guidelines ISO 10993 metrology and packaging evidence
Url
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