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  1. Export
  2. Commodities
  3. Medical device or in vitro diagnostics device
  4. Initial registration and licences
  5. Registration of premises for medical or in vitro diagnosis device
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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 3 expand_more expand_less

RIMS Customer Self Service Portal (x 3)
1 3 5
Bank
2
Tanzania Medicines and Medical Devices Authority
4

Results 2 expand_more expand_less

Registration certificate of premise
5
Business permit of a premise (TMDA)
5

Required Documents expand_more expand_less

Application form for medical device premise registration
1
Application form for licence
1
Tax Identification Number certificate
1
Memorandum and articles of association
1
Certificate of incorporation
1
Academic certificate
1
Commitment letter
1
Sketch location of the premise
1
TMDA profoma invoice
2

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 2d 1/2 - 10d  expand_more expand_less

  Min. Max.
Total time (sum): 2d 1/2 10d
of which:
Attention at counter: 25mn 1h. 15mn
Waiting time until next step (sum): 2d 9d

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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