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Summary

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Properties

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"Certification sheet" format

Steps (37)

Obtain registration certificate of premises for medical and in vitro diagnostic devices (5)

1 Submit application for premise registration

2 Pay registration and inspection fees

3 Obtain TFDA receipt

4 Inspection of premise

5 Obtain registration documents

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

6 Obtain TFDA profoma invoice for medical device or in vitro diagnostic registration

7 Pay registration fees

8 Obtain TFDA receipt

9 Submit technical file (dossier)

10 Obtain registration notification

11 Obtain medical device or in vitro diagnostics registration certificate

Pre-clearance documentation (3)

12 Contract a clearing agent

13 Obtain cargo clearance documents

14 Obtain TRA self assessment document

Obtain medical device or in vitro diagnostics import permit (5)

15 Obtain user credentials

16 Apply for import permit

17 Pay for medical device or in vitro diagnostics import permit

18 Obtain TFDA receipt

19 Obtain medical device or in vitro diagnostics import permit

Custom declaration (3)

20 Lodge custom documents (TRA)

21 Pay custom levy

22 Obtain Tanzania Single Administrative Document (TANSAD)

Verification of consignment (3)

23 Book for physical verification of consignment

24 Pay container freight station (CFS ) charges

25 Physical verification of consignment

Obtain TRA release order (2)

26 Submit stamped documents

27 Obtain release order

Obtain delivery order (3)

28 Submit bill of lading

29 Pay shipping line charges

30 Obtain delivery order

Port clearance (7)

31 Lodge cargo clearance documents (TPA)

32 Pay port charges

33 Obtain TPA receipt

34 Create truck announcement

35 Obtain gate in ticket

36 Cargo collection and security verification

37 Check point and gate out pass

7

Pay registration fees
(last modified: 03/03/2020)

Costs

( see details )

Timeframe ( see details )

USD 12,580

5 mn - 15 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

Expected results

Stamped bank deposit slip

Requirements

1.

TMDA profoma invoice

Cost USD 12,580

TZS

TZS Add Name Here

Registration of imported medical devices
USD 500 For medical device Class A non-exempted from registration
USD 2,500 For medical devices class B, C and D
USD 150 Variation-minor
USD 300 Variation-major
USD 200 Retention- Class A
USD 200 Class B, C and C
USD 100 Duplicate certificate
Registration of imported in vitro diagnostic devices
USD 350 Class A
USD 1,250 Class B
USD 1,500 Class C
USD 2,000 Class D
USD 125 Variation-minor
USD 250 Variation-major
USD 250 Retention
USD 100 Duplicate certificate
Other costs
Registration of domestic medical devices
USD 75 class B
USD 250 Class C,D
USD 75 Class B
USD 250 Class B and D
USD 50 Variation- minor
USD 75 Variation-major
USD 100 Retention
USD 25 Export certificate
USD 30 Duplicate certificate
Registration of domestic in vitro diagnostic devices
USD 125 Class A
USD 250 Class B
USD 375 Class C
USD 400 Class D
USD 125 Variation-minor
USD 250 Variation-major
USD 250 Retetion
USD 100 Duplicate certificate

Payment methods: cash, check, Maxmalipo and 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 Foods and Drugs Authority (TFDA). Payments can also be made through banks using the control number.

Time frame

Waiting time in queue: Max. 5mn

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

Legal justification

1.

Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015
Section 122(1)(i))schedule42-80

Additional information

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