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Steps (40) arrow_drop_up arrow_drop_down
Obtain registration certificate of premises for medical and in vitro diagnostic devices  (6) expand_more expand_less
Obtain medical device or in vitro diagnostic registration certificate  (6) expand_more expand_less
Pre-clearance documentation  (3) expand_more expand_less
Obtain medical device or in vitro diagnostics import permit  (5) expand_more expand_less
Obtain verified certificate of conformity  (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

arrow_drop_up arrow_drop_down
Summary of the procedure

Institutions involved 10 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 8)
Clearing Agent
Shipping Agents (x 3)
TBS Services Online Application System
TBS Import Inspection Office
CONTAINER FREIGHT STATION
Tanzania Revenue Authority-Headquarters (x 2)
Tanzania Ports Authority-Dar es salaam (x 4)

Results 7 expand_more expand_less

Registration certificate of premise
Business permit of a premise (TFDA)
Medical device certificate of registration
Permision to import medical devices
Verified certificate of conformity
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
TFDA profoma invoice (x 3)
Stamped bank deposit slip (x 6)
TFDA 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)
Clearing agent's authorization letter for customs (x 2)
Commercial invoice (x 3)
Packing list (x 3)
Certificate of origin (x 2)
Customer registration form
Registration certificate of premise (x 2)
Medical device certificate of registration
Proforma invoice
Certificate of analysis of products
Declaration of conformity of the device from the manufacturer
Certificate of conformity of the manufacturer to ISO 13485
Certificate of conformity
Self assessment document (TRA)
Product registration certificate
Certificate of conformity with TBS received stamp
Permision to import medical devices (x 2)
Verified certificate of conformity (x 2)
Control number (TRA)
Tanzania Single Administrative Document (TANSAD) (x 2)
Invoice (TICTS)
EAC certificate of origin
Consignment for verification (x 2)
Permission to import medical device with release order
EAC certificate of origin with release stamp
Verified certificate of conformity with TBS 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

Estimated cost TZS  350,000 + USD  13,219

expand_more expand_less

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
Inspection fee.
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
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
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
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
USD 0 -
3 % Cost, Insurance and Freight or Custom value
Clearing agent fees-estimate
USD 0 -
2 % goods-value
of FOB value of the consignment
Fee for Import Permit
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 228 d - 262 d expand_more expand_less

  Min. Max.
Total time (sum): 228 d 262 d
of which:
Waiting time in queue (sum): 1h. 25mn 8h. 20mn
Attention at counter: 3h. 35mn 9h. 15mn
Waiting time until next step (sum): 228 d 261 d

Laws 15 expand_more expand_less

Tarrif book (TPA) "Tariff book of port dues and charges (TPA)"
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
General goods PVoC procedures General goods PVoC procedures
  Section  24 ,  Article 4
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
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 and 10, 7, 14, 31 (2), 46, 47
TFDA fee and charges regulation Tanzania Food, Drugs and Cosmetics (Fee and Charges) Regulations, 2015
  Sections 4, 51, 122 (1) (i)) schedule 42- 80, first schedule
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, 28, 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
Used motorvehcle PVoC procedures Used motor vehicle PVoC procedures
  Section  4
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