List of steps
(Total number of steps: 13)
Obtain NEMC enviromental assessment certificate  (2)
Procure scoping report and TORs  (2)
Obtain scoping report and TORs approval  (2)
Actual EIA assessment  (1)
Obtain Medical device manufacturing license  (6)

Preview & Print

Properties
 
Summary of the procedure
 

Where to go? (5)

You will have to go to the following agencies. The number indicates how many interactions are required with each entity.
National Environment Management Council (NEMC) (x 3)
2 5 6
National Environment Management Council (NEMC)
Customer's Site (x 2)
7 12
Customer's Site
Tanzania Food and Drugs Authority (TFDA) HQ (x 3)
8 10 13
Tanzania Food and Drugs Authority (TFDA) HQ
National Microfinance Bank (NMB)
9
National Microfinance Bank (NMB)
TFDA Eastern Zone Office
11
TFDA Eastern Zone Office

What you will get (2)

The objective of the procedure is to obtain those documents.
Premise registration certificate
13
Premise registration certificate
TFDA Manufacturing license
13

Required documents 

The documents with green band will be provided to you during the procedure.

Scoping report approval letter
6
Application for license form 0003 (TFDA)
8
Application for license form 0003 (TFDA)
Premise Registration form 0001 (TFDA)
8
Premise Registration form 0001 (TFDA)
Certificate of incentives
8
Certificate of incentives
Memorandum and Articles of Association
8
Memorandum and Articles of Association
Plant lay-out
8
Plant lay-out
Environmental Clearance Certificate
8
Environmental Clearance Certificate
NMB Bank slip
9
NMB Bank slip
TFDA proforma invoice
9
TFDA proforma invoice
TFDA Payment receipt
10
TFDA Payment receipt
TFDA Payment receipt
11
TFDA Payment receipt
TFDA Payment receipt
13
TFDA Payment receipt

How much?

Cost of the procedure  TZS  500,000

Cost detail

Estimate your cost

TZS 200,000
Annual dealers fee for medical devices for medium scale manufacturer
TZS 300,000
Annual dealers fee for medical devices for large scale manufacturer

How long ?

The estimated total time is calculated by adding the time spent: 1) waiting in queue, 2) at the counter and 3) between steps.
  Min. Max.
Total time (sum): 1 d 5 d
of which:
Waiting time in queue (sum): 10mn 45mn
Attention at counter: 35mn 1h. 10mn
Waiting time until next step (sum): 0 d 5 d

Legal justification?

The regulations which justify the procedure and its content
THE TANZANIA FOOD, DRUGS AND COSMETICS ACT, 2003 THE TANZANIA FOOD, DRUGS AND COSMETICS ACT, 2003
  Article S. 22
THE TANZANIA FOOD, DRUGS AND COSMETICS ACT, 2003 THE TANZANIA FOOD, DRUGS AND COSMETICS ACT, CAP 219, 2003
  articles S. 7, S.18
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