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Steps (6) arrow_drop_up arrow_drop_down
Obtain registration certificate of premises for medical or in vitro diagnosis device  (6) expand_more expand_less

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Summary of the procedure

Institutions involved 2 expand_more expand_less

Tanzania Medicines and Medical Devices Authority (TMDA) ( Eastern zone office) (x 5)
Bank

Results 2 expand_more expand_less

Registration certificate of premise
Business permit of a premise (TFDA)

Required Documents expand_more expand_less

Application form for medical device premise registration
Application form for licence
Tax Identification Number certificate
Memorandum and articles of association
Certificate of incorporation
Academic certificate
Commitment letter
Sketch location of the premise
TFDA profoma invoice
Stamped bank deposit slip
TFDA receipt

Estimated cost TZS  350,000

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USD expand_more expand_less
  • USD Add Name Here
TZS 300,000
Premise registration fee
TZS 50,000
Premise inspection fee

Total Duration 8 d - 18 d expand_more expand_less

  Min. Max.
Total time (sum): 8 d 18 d
of which:
Waiting time in queue (sum): 10mn 55mn
Attention at counter: 30mn 1h. 25mn
Waiting time until next step (sum): 8 d 17 d

Laws 3 expand_more expand_less

Tanzania Food, Drug and Cosmetics (Control of Medicine Device) regulation 2015 Tanzania Food, Drug and Cosmetics (Control of Medical Device) Regulations, 2015
  Sections 5, 6, 7, 14, 31 (2)
TFDA fee and charges regulation Tanzania Food, Drugs and Cosmetics (Fee and Charges) Regulations, 2015
  Section  4
THE TANZANIA FOOD, DRUGS AND COSMETICS ACT, CAP 219, 2003 The Tanzania Food, Drugs and Cosmetics Act, 2003
  Sections 5 (h), 18, 20, 21
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