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  1. Export
  2. Commodities
  3. Medical device or in vitro diagnostics device
  4. Full procedure view - for a first time trader
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Properties

Steps (30) arrow_drop_up arrow_drop_down
Obtain registration certificate of premises for medical or in vitro diagnosis device  (5) expand_more expand_less
Obtain medical device or in vitro diagnostic devices registration certificate  (6) expand_more expand_less
Obtain medical device or in vitro diagnosis device export permit  (2) expand_more expand_less
Pre-clearance documentation  (2) expand_more expand_less
Custom declaration  (2) expand_more expand_less
Consignment inspection  (2) expand_more expand_less
Obtain TRA release order  (2) expand_more expand_less
Port clearance  (5) expand_more expand_less
Obtain EAC certificate of origin  (4) expand_more expand_less

arrow_drop_up arrow_drop_down
Summary of the procedure

Institutions involved 14 expand_more expand_less

RIMS Customer Self Service Portal (x 4)
1 3 5 6
Bank (x 3)
2 7 23
Tanzania Medicines and Medical Devices Authority
4
Tanzania Medicines and Medical Devices Authority (TMDA), Sub- Head Office (x 5)
8 9 10 11 13
Customer online self service portal (RIMS - TMDA)
12
Clearing Agent
14
Shipping Agents
15
Tanzania Custom Intergrated System (x 3)
16 17 20
Tanzania Revenue Authority-Headquarters (x 3)
18 19 21
TPA Electronic Payment Portal (TePP) (x 2)
22 24
Tanzania Ports Authority-Dar es salaam (x 2)
25 26
Tanzania Chamber of Commerce, Industry & Agriculture (TCCIA) (x 2)
27 30
Certificate of origin electronic management, verification and issuance.
28
Mobile E payment
29

Results 7 expand_more expand_less

Registration certificate of premise
5
Business permit of a premise (TMDA)
5
Medical device certificate of registration
11
Medical device export permit
13
Shipping order
15
Release order
21
EAC certificate of origin
30

Required Documents expand_more expand_less

Application form for medical device premise registration
1
Application form for licence
1
Tax Identification Number certificate (x 3)
1 14 16
Memorandum and articles of association
1
Certificate of incorporation
1
Academic certificate
1
Commitment letter
1
Sketch location of the premise
1
TMDA profoma invoice (x 2)
2 7
Application form for registration of medical devices (x 2)
6 9
Cover letter (x 2)
6 9
Technical file (x 2)
6 9
Label of medical device (x 2)
6 9
Instructions for use (x 2)
6 9
Patient information leaflet (x 2)
6 9
Sterilization validation report (x 2)
6 9
Certification on IVDD methodology (x 2)
6 9
Certification of electrical safety standards (x 2)
6 9
Description of the medical device (x 2)
6 9
Description of the features of the medical devices (x 2)
6 9
List and summary of the countries (x 2)
6 9
Risk assessment comprising an analysis and evaluation of risk (x 2)
6 9
Specification of the materials used (x 2)
6 9
Stamped bank deposit slip (x 2)
8 30
TMDA receipt (x 2)
9 11
Profoma invoice
12
Clearing agent's authorization letter for customs (x 2)
14 16
Commercial invoice (x 5)
14 15 16 19 28
Packing list (x 5)
14 15 16 19 28
Plant import permit from importing country
14
Clearing agent's authorization letter for shipping line
15
Medical device export permit (x 2)
16 19
Business licence
16
EAC certificate of origin (x 2)
16 19
Tanzania Single Administrative Document (TANSAD) (x 2)
18 19
Shipping order (x 4)
18 19 22 25
Consignment (container)
19
Medical device export permit with release stamp
20
EAC certificate of origin with release stamp
20
Release order (x 2)
22 25
TPA payment note
23
Driver details
24
TPA receipt
25
Truck registration card
25
Driving licence
25
Form for verification of origin (EAC)
27
Consignment for verification
27
TCCIA account numbers
29

Estimated cost TZS  357,000 +USD  155

expand_more expand_less

TZS expand_more expand_less
  • TZS Add Name Here
This is an estimate based on a series of assumptions which you can modify to calculate your own costs:

Cost detail

Estimate your cost

TZS 300,000
Premise registration fee
TZS 50,000
Premise inspection fee
USD 75
Registration fee for class B
USD 0 -
3 % goods-value
Clearing agent fees-estimate
0 mode_edit
TZS 0 -
1 % goods-value
For wharfage export charges
0 mode_edit
USD 80
Handling fee for a 20ft container
TZS 5,000
Fee for certificate of origin for EAC countries
TZS 2,000
Printing cost for certificate of origin

Total Duration 224d - 285d  expand_more expand_less

  Min. Max.
Total time (sum): 224d 285d
of which:
Waiting time in queue (sum): 45mn 3h. 20mn
Attention at counter: 3h. 5mn 1d 1/2
Waiting time until next step (sum): 223d 284d

Laws 10 expand_more expand_less

East African Community Customs Management Act, 2004 (Revised Edition 2017) East African Community Customs Management Act, 2004 (Revised Edition 2019)
  Sections 41, 73, 74, 75, 76, 82, 123, 145, 146, 147, 148, 181, 187, 188, 189
East African Community Customs Management Regulations (2010) East African Community Customs Management Regulations, 2010
  Sections 38, 40, 44, 45, 46, 53, 74, 89
Guidline for registration of Medical and In vitro diagostic device Guideline on submission of documentation for registration of medical and in vitro diagostic device
  Section  2
GUIDELINES ON SUBMISSION OF DOCUMENTATION FOR REGISTRATION OF MEDICAL DEVICES Guidelines on Submission of Documentation for Registration of Medical Devices
Tanzania Food, Drug and Cosmetics (Control of Medicine Device) regulation 2015 Tanzania Food, Drug and Cosmetics (Control of Medical Device) Regulations, 2015
  Sections 6, 7, 10, 13, 14, 17, 24, 31, 32 (2), 46, 47
TFDA fee and charges regulation Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 First schedule
  Section  4
Tarrif book (TPA) Tariff Book of Port Dues and Charges (TPA) Clause 14, 29
EAC Union Rules of Origin,2015 The East African Community ( EAC) Custom Union (Rules of Origin), 2015
  articles Rule 17, Rules 17 (5), Rules 17 (6)
THE TANZANIA FOOD, DRUGS AND COSMETICS ACT, CAP 219, 2003 The Tanzania Food, Drugs and Cosmetics Act, 2003
  Sections 5 (h), 18, 20, 21, 52, 53
The Tanzania Harbours Regulations, 1991 The Tanzania Harbours Regulations, 1991
  Sections 212, 222, 239, 241, 252, 274, 275, 276, 277, 278, 279, 284, 286, 287, 304
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