1. MEDICINES AND DEVICES LICENCES FROM TMDA
  2. Business permit for Drugs and medical devices
  3. Business permit for manufacturing
  4. Obtain medical device manufacturing permit
print

Preview & Print

Properties

Preview & Print

Properties

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

arrow_drop_up arrow_drop_down
Summary of the procedure

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

expand_more expand_less

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 - 6d  expand_more expand_less

  Min. Max.
Total time (sum): 45mn 6d
of which:
Waiting time in queue (sum): 10mn 45mn
Attention at counter: 35mn 1h. 10mn
Waiting time until next step (sum): 0mn 5d

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
Powered by eRegulations ©, a content management system developed by UNCTAD's Business Facilitation Program and licensed under Creative Commons License