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Steps (13) arrow_drop_up arrow_drop_down
Obtain NEMC enviromental assessment certificate  (2) expand_more expand_less
Procure scoping report and TORs  (2) expand_more expand_less
Obtain scoping report and TORs approval  (2) expand_more expand_less
Actual EIA assessment  (1) expand_more expand_less
Obtain Medical device manufacturing license  (6) expand_more expand_less

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Summary of the procedure

Institutions involved 5 expand_more expand_less

National Environment Management Council (NEMC) (x 3)
Customer's premise/workplace (x 2)
Tanzania Food and Drugs Authority (TFDA) HQ (x 3)
National Microfinance Bank (NMB)
TFDA Eastern Zone Office

Results 2 expand_more expand_less

Premise registration certificate
TFDA Manufacturing license

Required Documents expand_more expand_less

Scoping report approval letter
Application for license form 0003 (TFDA)
Application for license form 0003 (TFDA)
Premise Registration form 0001 (TFDA)
Premise Registration form 0001 (TFDA)
Certified Certificate of incentives
Memorandum and Articles of Association or charter or statutes
Plant lay-out
Environmental Clearance Certificate
NMB Bank slip
TFDA proforma invoice
TFDA Payment receipt
TFDA Payment receipt
TFDA Payment receipt

Estimated cost Tanzanian Shilling  500,000

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USD expand_more expand_less
  • USD Add Name Here
Tanzanian Shilling 200,000
Annual dealers fee for medical devices for medium scale manufacturer
Tanzanian Shilling 300,000
Annual dealers fee for medical devices for large scale manufacturer

Total Duration 1 d - 6 d expand_more expand_less

  min max
Total time (sum): 1 d 6 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

Laws 2 expand_more expand_less

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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