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The Tanzania Trade Portal is managed by the Tanzania Trade Development Authority (TanTrade) under the auspices of the National Trade Facilitation Committee (NTFC)

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Summary

Preview & Print

Properties

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"Certification sheet" format

Steps (6)

Obtain medical device or in vitro diagnostic devices registration certificate (6)

1 Apply for medical device or in vitro diagnostic devices registration

2 Pay registration fees

3 Obtain TMDA receipt

4 Submit technical file (dossier)

5 Obtain registration notification

6 Obtain medical device or in vitro diagnostics devices registration certificate

2

Pay registration fees
(last modified: 17/01/2022)

You can pay for this step online

Pay online

Costs

( see details )

Timeframe ( see details )

USD 2,650

5 mn - 25 mn

Contact details

Entity in charge

Bank

Unit in charge

Bank hall

Mon:	08:00 - 16:30
Tue:	08:00 - 16:30
Wed:	08:00 - 16:30
Thu:	08:00 - 16:30
Fri:	08:00 - 16:30
Sat:	08:30 - 12:00

NMB and TIB bank Dar es salaam ports branches works 24 hours 7 days.

Person in charge

Bank Teller

List of banks and bank accounts

Expected results

Stamped bank deposit slip

Mobile money text as proof of payment

Requirements

1.

TMDA profoma invoice

Cost USD 75

TZS

TZS Add Name Here

Registration of domestic medical devices
USD 75 Registration fee for class B
or USD 250 Registration fee for class C and D
or USD 75 Registration fee for class B
or USD 250 Registration fee for class B and D
or USD 50 Registration fee for variation- minor
or USD 75 Registration fee for variation-major
or USD 100 Registration fee for retention
Other costs
Registration of domestic In Vitro Diagnostic
or USD 125 Registration fee for class A
or USD 250 Registration fee for class B
or USD 375 Registration fee for class C
or USD 400 Registration fee for class D
or USD 125 Registration fee for variation-minor
or USD 250 Registration fee for variation-major
or USD 250 Registration fee for retention

Payment methods: cash, check, Mobile money

For Mpesa, Dial *150*00# . For Tigopesa, Dial *150*01# . Select government payment, payment number will be the control number. (The payment number for both platforms is the valid control number obtained from the Tanzania Medicine and Medical devices Authority (TMDA). Payments can also be made through banks using the control number.

Time frame

Waiting time in queue: Max. 15mn

Attention at counter: Min. 5mn - Max. 10mn

Legal justification

1.

Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 First schedule 42-80

Additional information

Variation Means a change to any aspect of a pharmaceutical product, including but not limited to a change to formulation, method and site of manufacture, specifications for the finished product and ingredients, container and container labeling and product information.