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"Certification sheet" format

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"Certification sheet" format

Steps (32)

Obtain registration certificate of premises for medical or in vitro diagnosis device (5)

1 Submit application for premise registration

2 Pay registration and inspection fees

3 Obtain TMDA receipt

4 Inspection of premise

5 Obtain registration documents

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

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

7 Pay registration fees

8 Obtain TMDA receipt

9 Submit technical file (dossier)

10 Obtain registration notification

11 Obtain medical device or in vitro diagnostics devices registration certificate

Obtain medical device or in vitro diagnosis device export permit (3)

12 Obtain user credentials

13 Apply for medical device or in vitro diagnostics export permit

14 Obtain medical device or in vitro diagnostics export permit

Pre-clearance documentation (2)

15 Contract a clearing agent

16 Book shipping space with shipping line

Custom declaration (2)

17 Lodge custom documents (TRA)

18 Obtain Tanzania Single Administrative Document (TANSAD)

Consignment inspection (2)

19 Request for consignment inspection

20 Consignment inspection and stuffing

Obtain TRA release order (2)

21 Submit stamped documents

22 Obtain release order

Port clearance (5)

23 Lodge cargo clearance documents (TPA)

24 Pay port charges

25 Create truck or driver announcement

26 Obtain gate in ticket

27 Obtain gate out permission

Obtain EAC certificate of origin (5)

28 Obtain online user credentials

29 Verification of goods

30 Apply for certificate of origin

31 Pay certificate fees

32 Obtain certificate of origin

Summary of the procedure

Institutions involved 13

Tanzania Medicines and Medical Devices Authority (TMDA) ( Eastern zone office) (x 4)

1 3 4 5

Bank (x 3)

2 7 24

Tanzania Medicines and Medical Devices Authority (TMDA), Sub- Head Office (x 7)

6 8 9 10 11 12 14

Customer online self service portal (TMDA)

Clearing Agent

Shipping Agents

Tanzania Custom Intergrated System (x 3)

17 18 21

Tanzania Revenue Authority-Headquarters (x 3)

19 20 22

TPA Intergated Electronic Payment System Portal (x 2)

23 25

Tanzania Ports Authority-Dar es salaam (x 2)

26 27

Certificate of origin electronic management, verification and issuance. (x 2)

28 30

Tanzania Chamber of Commerce, Industry & Agriculture (TCCIA) (x 2)

29 32

Mobile E payment

Results 7

Registration certificate of premise

Business permit of a premise (TFDA)

Medical device certificate of registration

Medical device export permit

Shipping order

Release order

EAC certificate of origin

Required Documents

Application form for medical device premise registration

Application form for licence

Tax Identification Number certificate (x 3)

1 15 17

Memorandum and articles of association

Certificate of incorporation

Academic certificate

Commitment letter

Sketch location of the premise

TMDA profoma invoice. (x 2)

2 7

Stamped bank deposit slip (x 3)

3 8 32

TMDA receipt (x 3)

5 9 11

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

Customer registration form

Registration certificate of premise

Profoma invoice

Clearing agent's authorization letter for customs (x 2)

15 17

Commercial invoice (x 5)

15 16 17 20 30

Packing list (x 5)

15 16 17 20 30

Plant import permit from importing country

Clearing agent's authorization letter for shipping line

Medical device export permit (x 2)

17 20

Business licence

EAC certificate of origin (x 2)

17 20

Tanzania Single Administrative Document (TANSAD) (x 2)

19 20

Shipping order (x 4)

19 20 23 26

Consignment (container)

Medical device export permit with release stamp

EAC certificate of origin with release stamp

Release order (x 2)

23 26

TPA payment note

Driver details

TPA receipt

Truck registration card

Driving licence

Form for verification of origin (EAC)

Consignment for verification

TCCIA account numbers

Estimated cost TZS 357,000 +USD 155

TZS

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
- TZS 0 - 1 % goods-value For wharfage export charges	0
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 230d - 295d

	Min.	Max.
Total time (sum):	230d	295d
of which:
Waiting time in queue (sum):	1h.	4h. 30mn
Attention at counter:	3h. 25mn	1d 1/2
Waiting time until next step (sum):	229d	293d

Laws 10

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