1. Food and Drugs license from TFDA
  2. Obtain Business Permits
  3. Business permits for manufacturing
  4. Obtain medical device manufacturing permit
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Vista previa e impresión

Propiedades

Vista previa e impresión

Propiedades

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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Resumen del procedimento

Institutions involved 5 expand_more expand_less

National Environment Management Council (NEMC) (x 3)
2 5 6
Customer's premise/workplace (x 2)
7 12
Tanzania Medicines and Medical Devices Authority (TMDA) HQ (x 3)
8 10 13
National Microfinance Bank (NMB)
9
TMDA Eastern Zone Office
11

Results 2 expand_more expand_less

Premise registration certificate
13
TFDA Manufacturing license
13

Required Documents expand_more expand_less

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

Estimated cost TZS  500,000

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TZS expand_more expand_less
  • TZS Add Name Here
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

Total Duration 45mn - 6días  expand_more expand_less

  Min. Max.
Duración total: 45mn 6días
de la cual:
Espera en fila: 10mn 45mn
Atención en ventanilla: 35mn 1h. 10mn
Entre pasos: 0mn 5días

Laws 2 expand_more expand_less

THE TANZANIA FOOD, DRUGS AND COSMETICS ACT, 2003 THE TANZANIA FOOD, DRUGS AND COSMETICS ACT, 2003
  Artículo S. 22
THE TANZANIA FOOD, DRUGS AND COSMETICS ACT, 2003 THE TANZANIA FOOD, DRUGS AND COSMETICS ACT, CAP 219, 2003
  Artículos S. 7, S.18
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