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Properties

Steps (36) arrow_drop_up arrow_drop_down
Obtain registration certificate of premises for medical and in vitro diagnostic devices  (5) expand_more expand_less
Obtain medical device or in vitro diagnostic registration certificate  (6) expand_more expand_less
Obtain medical devices or in vitro diagnostics import permit  (5) expand_more expand_less
Pre-clearance documentation  (2) expand_more expand_less
Custom declaration  (3) expand_more expand_less
Verification of consignment  (3) expand_more expand_less
Obtain TRA release order  (2) expand_more expand_less
Obtain delivery order  (3) expand_more expand_less
Port clearance  (7) expand_more expand_less

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Summary of the procedure

Institutions involved 10 expand_more expand_less

Tanzania Medicines and Medical Devices Authority (TMDA) ( Eastern zone office) (x 4)
Tanzania Medicines and Medical Devices Authority (TMDA), Sub- Head Office (x 8)
Customer online self service portal (TMDA)
Clearing Agent
Shipping Agents (x 3)
Tanzania Custom Intergrated System (x 2)
CONTAINER FREIGHT STATION
Tanzania Revenue Authority-Headquarters (x 2)
Tanzania Ports Authority-Dar es salaam (x 4)

Results 6 expand_more expand_less

Registration certificate of premise
Business permit of a premise (TFDA)
Medical device certificate of registration
Permision to import medical devices
Release order
Delivery 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
TMDA profoma invoice (x 3)
Stamped bank deposit slip (x 6)
TMDA receipt (x 4)
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
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 (x 2)
Medical device certificate of registration
Certificate of analysis of products
Proforma invoice
Certificate of origin
Bill of lading
Clearing agent's authorization letter for customs
Clearing agent authorization letter
Permision to import medical devices (x 2)
Certificate of origin (x 2)
Packing list (x 2)
Commercial invoice (x 2)
Control number (TRA)
Tanzania Single Administrative Document (TANSAD) (x 2)
Invoice (TICTS)
Consignment for verification (x 2)
Permission to import medical device with release order
Certificate of origin with release stamp
Shipping line invoice
Importer identitification card
Clearing and forwarding agent identification card
Release order (x 4)
Delivery order (x 4)
TPA payment note with reference number
Driver details
Truck registration card
Driving licence
Gate in ticket (x 2)
Gate pass 'A' Manifest Cargo
Representatives
Clearing agent authorization letter

Estimated cost TZS  350,000 +USD  1,489

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
Inspection fee.
USD 500
For medical device Class A non-exempted from registration
USD 350
Class A
USD 0 -
2 % Free On Board (FOB)
Import permit fee
USD 0 -
3 % Cost, Insurance and Freight or Custom value
Clearing agent fees-estimate
TZS 0 -
1.6 % Custom value
For imported products
TZS 0 -
1.5 % Custom value
Railway Development Levy RDL
TZS 0 -
0.6 % Free On Board (FOB)
Custom Processing Charge CPC
TZS 0 -
18 % Custom value
Value added tax VAT
USD 240
Handling fee for a 20ft container
USD 50
Documentation fee-estimate
USD 45
Delivery order fee-estimate
USD 18
Shipping service fee-estimate
USD 6
Corridor levy
USD 20
Handling fee for 20ft container
USD 160
Handling fee for a 20ft container
USD 100
Handling fee for a 20ft container

Total Duration 229d - 261d  expand_more expand_less

  Min. Max.
Total time (sum): 229d 261d
of which:
Waiting time in queue (sum): 1h. 25mn 1d 1/2
Attention at counter: 3h. 25mn 1d 1/2
Waiting time until next step (sum): 228d 259d

Laws 13 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 2, 33, 34, 38, 41, 125, 126, 127, 145, 146, 147, 148, 181, 188, 235
East African Community Customs Management Regulations (2010) East African Community Customs Management Regulations, 2010
  Sections 39, 40, 44, 45, 46, 50, 53, 131
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 for importation and exportation of medical devices including in vitro diagnostics Guidelines for importation and exportation of medical devices including in vitro diagnostics
Guidelines on Submission of Documentation for Registration of In Vitro Diagnostics Devices May, 2018 Guidelines on Submission of Documentation for Registration of In Vitro Diagnostics Devices May, 2018
  Section  2
GUIDELINES ON SUBMISSION OF DOCUMENTATION FOR REGISTRATION OF MEDICAL DEVICES Guidelines on Submission of Documentation for Registration of Medical Devices
Ocean freight tariff Ocean freight tariff
  Article Table 9
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
  Sections 4, 51, 122 (1) (i)) schedule 42- 80, first schedule
Tarrif book (TPA) Tariff book of port dues and charges (TPA) Clause 39, 40, 42
THE TANZANIA FOOD, DRUGS AND COSMETICS ACT, CAP 219, 2003 The Tanzania Food, Drugs and Cosmetics Act, 2003
  Sections 5 (h), 18, 20, 46, 52, 53
The Tanzania Harbours Regulations, 1991 The Tanzania Harbours Regulations, 1991
  Sections 210, 222, 286, 287, 304
The value added tax Act, 2014 The Value Added Tax Act, 2014
  Section  3
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