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Steps (5) arrow_drop_up arrow_drop_down
Obtain registration certificate of premises for medical or in vitro diagnosis device  (5) 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 4)
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
TMDA profoma invoice
Stamped bank deposit slip
TMDA receipt

Estimated cost TZS  350,000

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

Total Duration 9d - 18d  expand_more expand_less

  Min. Max.
Total time (sum): 9d 18d
of which:
Waiting time in queue (sum): 10mn 1h.
Attention at counter: 25mn 1h. 15mn
Waiting time until next step (sum): 8d 17d

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 24, 31, 32 (2)
TFDA fee and charges regulation Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 First schedule
  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
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