Preview & Print


Preview & Print


Steps (34) arrow_drop_up arrow_drop_down
Obtain registration certificate of premises for medical or in vitro diagnosis device  (6) 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  (3) expand_more expand_less
Obtain EAC certificate of origin  (5) 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  (6) expand_more expand_less

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Summary of the procedure

Institutions involved 8 expand_more expand_less

Tanzania Medicines and Medical Devices Authority (TMDA) ( Eastern zone office) (x 5)
Tanzania Medicines and Medical Devices Authority (TMDA), Sub- Head Office (x 7)
Tanzania Chamber of Commerce, Industry & Agriculture (TCCIA) (x 2)
Clearing Agent
Shipping Agents
Tanzania Revenue Authority-Headquarters (x 3)
Tanzania Ports Authority-Dar es salaam (x 3)

Results 7 expand_more expand_less

Registration certificate of premise
Business permit of a premise (TFDA)
Medical device certificate of registration
Medical device export permit
EAC certificate of origin
Shipping order
Release order

Required Documents expand_more expand_less

Application form for medical device premise registration
Application form for licence
Tax Identification Number certificate (x 3)
Memorandum and articles of association
Certificate of incorporation
Academic certificate
Commitment letter
Sketch location of the premise
TFDA profoma invoice (x 2)
Stamped bank deposit slip (x 4)
TFDA receipt (x 3)
Application form for registration of medical devices (x 2)
Cover letter (x 2)
Technical file (x 2)
Label of medical device (x 2)
Instructions for use (x 2)
Patient information leaflet (x 2)
Sterilization validation report (x 2)
Certification on IVDD methodology (x 2)
Certification of electrical safety standards (x 2)
Description of the medical device (x 2)
Description of the features of the medical devices (x 2)
List and summary of the countries (x 2)
Risk assessment comprising an analysis and evaluation of risk (x 2)
Specification of the materials used (x 2)
Customer registration form
Registration certificate of premise
Profoma invoice
Form for verification of origin (EAC)
Consignment for verification
Packing list (x 5)
Commercial invoice (x 5)
Bank deposit slip
Clearing agent's authorization letter for customs (x 2)
Clearing agent's authorization letter for shipping line
Medical device export permit (x 2)
Business licence
EAC certificate of origin (x 2)
Tanzania Single Administrative Document (TANSAD) (x 2)
Shipping order (x 4)
Consignment (container)
Medical device export permit with release stamp
EAC certificate of origin with release stamp
Release order (x 2)
Invoice (TPA)
Driver details
TPA receipt
Truck registration card
Driving licence

Estimated cost TZS  357,000 + USD  1,005

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USD expand_more expand_less
  • USD 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 500
Registration fee for medical device Class A
USD 75
Registration fee for class B
USD 350
Registration fee for class A
TZS 5,000
Fee for certificate of origin for EAC countries
TZS 2,000
Printing cost for certificate of origin
USD 0 -
3 % goods-value
Clearing agent fees-estimate
USD 80
Handling fee for a 20ft container

Total Duration 229 d - 295 d expand_more expand_less

  Min. Max.
Total time (sum): 229 d 295 d
of which:
Waiting time in queue (sum): 1h. 5mn 5h. 10mn
Attention at counter: 3h. 15mn 9h.
Waiting time until next step (sum): 229 d 294 d

Laws 10 expand_more expand_less

Tarrif book (TPA) "Tariff book of port dues and charges (TPA)" But the whole tariff book shows Tanzania ports charges.
  Article Clause 33. 35
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, 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, 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
Tanzania Food, Drug and Cosmetics (Control of Medicine Device) regulation 2015 Tanzania Food, Drug and Cosmetics (Control of Medical Device) Regulations, 2015
  Sections 5, 6, 7, 10, 13, 14, 31 (2), 46, 47
TFDA fee and charges regulation Tanzania Food, Drugs and Cosmetics (Fee and Charges) Regulations, 2015
  Section  4 ,  Article First schedule 42-80
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)
Port service charges Act The Port Service Charges Act
  Section  8
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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